Clinical trial: NCT02494921
Section: Alternatives
Subsections: W H At Ot Her C H Oices D O I H A Ve If I D O N Ot T A Ke P Art I N T His St U D Y ? Y O Ur Ot Her C H Oices Ma Y I Ncl U De:|W H At Ot Her C H Oices D O I H A Ve If I D O N Ot T A Ke P Art I N T His St U D Y ? Y O Ur Ot Her C H Oices Ma Y I Ncl U De:|W H At Ot Her C H Oices D O I H A Ve If I D O N Ot T A Ke P Art I N T His St U D Y ? Y O Ur Ot Her C H Oices Ma Y I Ncl U De:|W H At Ot Her C H Oices D O I H A Ve If I D O N Ot T A Ke P Art I N T His St U D Y ? Y O Ur Ot Her C H Oices Ma Y I Ncl U De:

Getti n g treat me nt or care f or y o ur ca ncer wit h o ut bei n g i n a st u d y.  
Ta ki n g part i n a n ot her st u d y.  
Getti n g n o treat me nt.  
Getti n g c o mf ort care als o calle d palliati ve care. T his t y pe of care hel ps re d uce pai n, tire d ness, a p petite pr o ble ms a n d ot her pr o ble ms ca use d b y t he ca ncer. It d oes n ot treat t he ca ncer directl y b ut i nstea d tries t o i m pr o ve h o w y o u feel. C o mf ort care tries t o kee p y o u as acti ve a n d c o mf orta ble as p ossi ble.  
Please tal k t o y o ur d oct or a b o ut y o ur c h oices bef ore deci di n g if y o u will ta ke part i n t his st u d y.

Getti n g treat me nt or care f or y o ur ca ncer wit h o ut bei n g i n a st u d y.  
Ta ki n g part i n a n ot her st u d y.  
Getti n g n o treat me nt.  
Getti n g c o mf ort care als o calle d palliati ve care. T his t y pe of care hel ps re d uce pai n, tire d ness, a p petite pr o ble ms a n d ot her pr o ble ms ca use d b y t he ca ncer. It d oes n ot treat t he ca ncer directl y b ut i nstea d tries t o i m pr o ve h o w y o u feel. C o mf ort care tries t o kee p y o u as acti ve a n d c o mf orta ble as p ossi ble.  
Please tal k t o y o ur d oct or a b o ut y o ur c h oices bef ore deci di n g if y o u will ta ke part i n t his st u d y.

Getti n g treat me nt or care f or y o ur ca ncer wit h o ut bei n g i n a st u d y.  
Ta ki n g part i n a n ot her st u d y.  
Getti n g n o treat me nt.  
Getti n g c o mf ort care als o calle d palliati ve care. T his t y pe of care hel ps re d uce pai n, tire d ness, a p petite pr o ble ms a n d ot her pr o ble ms ca use d b y t he ca ncer. It d oes n ot treat t he ca ncer directl y b ut i nstea d tries t o i m pr o ve h o w y o u feel. C o mf ort care tries t o kee p y o u as acti ve a n d c o mf orta ble as p ossi ble.  
Please tal k t o y o ur d oct or a b o ut y o ur c h oices bef ore deci di n g if y o u will ta ke part i n t his st u d y.

Getti n g treat me nt or care f or y o ur ca ncer wit h o ut bei n g i n a st u d y.  
Ta ki n g part i n a n ot her st u d y.  
Getti n g n o treat me nt.  
Getti n g c o mf ort care als o calle d palliati ve care. T his t y pe of care hel ps re d uce pai n, tire d ness, a p petite pr o ble ms a n d ot her pr o ble ms ca use d b y t he ca ncer. It d oes n ot treat t he ca ncer directl y b ut i nstea d tries t o i m pr o ve h o w y o u feel. C o mf ort care tries t o kee p y o u as acti ve a n d c o mf orta ble as p ossi ble.  
Please tal k t o y o ur d oct or a b o ut y o ur c h oices bef ore deci di n g if y o u will ta ke part i n t his st u d y.
Clinical trial: NCT02494921
Section: Confidentiality
Subsections: Will M Y Me Dic Al I Nf Or M Ati O N Be Ke Pt Pri V Ate ?|Will M Y Me Dic Al I Nf Or M Ati O N Be Ke Pt Pri V Ate ?|Will M Y Me Dic Al I Nf Or M Ati O N Be Ke Pt Pri V Ate ?|Will M Y Me Dic Al I Nf Or M Ati O N Be Ke Pt Pri V Ate ?

We will d o o ur best t o ma ke s ure t hat t he pers o nal i nf or mati o n i n y o ur me dical rec or d is ke pt pri vate. H o we ver, we ca n n ot g uara ntee t otal pri vac y. Y o ur pers o nal i nf or mati o n ma y be gi ve n o ut if re q uire d b y la w. If i nf or mati o n fr o m t his st u d y is p u blis he d or prese nte d at scie ntific meeti n gs, y o ur na me a n d ot her pers o nal i nf or mati o n will n ot be use d.  
Or ga nizati o ns t hat ma y l o o k at a n d/ or c o p y y o ur me dical rec or ds f or researc h, q ualit y ass ura nce, a n d data a nal ysis i ncl u de:  
N o vartis (t he dr u g s u p plier) a n d its a ut h orize d a ge nts Pr ostate Ca ncer F o u n dati o n T he U ni versit y of Calif or nia T he Nati o nal Ca ncer I nstit ute ( N CI) a n d ot her g o ver n me nt a ge ncies, e. g., t he F o o d a n d Dr u g A d mi nistrati o n ( F D A), i n v ol ve d i n kee pi n g researc h safe f or pe o ple. G o ver n me ntal a ge ncies i n ot her c o u ntries w here t he st u d y dr u g ma y be c o nsi dere d f or a p pr o val.  
Partici pati o n i n researc h ma y i n v ol ve a l oss of pri vac y, b ut i nf or mati o n a b o ut y o u will be ha n dle d as c o nfi de ntiall y as p ossi ble. A me dical rec or d will be create d beca use of y o ur partici pati o n i n t his st u d y. Y o ur c o nse nt f or m a n d s o me of y o ur researc h test res ults will be  
  
i ncl u de d i n t his rec or d. T heref ore, y o ur ot her d oct ors ma y bec o me a ware of y o ur partici pati o n.  
H os pital re g ulati o ns re q uire t hat all healt h care pr o vi ders treat i nf or mati o n i n me dical rec or ds c o nfi de ntiall y.

We will d o o ur best t o ma ke s ure t hat t he pers o nal i nf or mati o n i n y o ur me dical rec or d is ke pt pri vate. H o we ver, we ca n n ot g uara ntee t otal pri vac y. Y o ur pers o nal i nf or mati o n ma y be gi ve n o ut if re q uire d b y la w. If i nf or mati o n fr o m t his st u d y is p u blis he d or prese nte d at scie ntific meeti n gs, y o ur na me a n d ot her pers o nal i nf or mati o n will n ot be use d.  
Or ga nizati o ns t hat ma y l o o k at a n d/ or c o p y y o ur me dical rec or ds f or researc h, q ualit y ass ura nce, a n d data a nal ysis i ncl u de:  
N o vartis (t he dr u g s u p plier) a n d its a ut h orize d a ge nts Pr ostate Ca ncer F o u n dati o n T he U ni versit y of Calif or nia T he Nati o nal Ca ncer I nstit ute ( N CI) a n d ot her g o ver n me nt a ge ncies, e. g., t he F o o d a n d Dr u g A d mi nistrati o n ( F D A), i n v ol ve d i n kee pi n g researc h safe f or pe o ple. G o ver n me ntal a ge ncies i n ot her c o u ntries w here t he st u d y dr u g ma y be c o nsi dere d f or a p pr o val.  
Partici pati o n i n researc h ma y i n v ol ve a l oss of pri vac y, b ut i nf or mati o n a b o ut y o u will be ha n dle d as c o nfi de ntiall y as p ossi ble. A me dical rec or d will be create d beca use of y o ur partici pati o n i n t his st u d y. Y o ur c o nse nt f or m a n d s o me of y o ur researc h test res ults will be
i ncl u de d i n t his rec or d. T heref ore, y o ur ot her d oct ors ma y bec o me a ware of y o ur partici pati o n.  
  
H os pital re g ulati o ns re q uire t hat all healt h care pr o vi ders treat i nf or mati o n i n me dical rec or ds c o nfi de ntiall y.

We will d o o ur best t o ma ke s ure t hat t he pers o nal i nf or mati o n i n y o ur me dical rec or d is ke pt pri vate. H o we ver, we ca n n ot g uara ntee t otal pri vac y. Y o ur pers o nal i nf or mati o n ma y be gi ve n o ut if re q uire d b y la w. If i nf or mati o n fr o m t his st u d y is p u blis he d or prese nte d at scie ntific meeti n gs, y o ur na me a n d ot her pers o nal i nf or mati o n will n ot be use d.  
Or ga nizati o ns t hat ma y l o o k at a n d/ or c o p y y o ur me dical rec or ds f or researc h, q ualit y ass ura nce, a n d data a nal ysis i ncl u de:  
N o vartis (t he dr u g s u p plier) a n d its a ut h orize d a ge nts Pr ostate Ca ncer F o u n dati o n T he U ni versit y of Calif or nia T he Nati o nal Ca ncer I nstit ute ( N CI) a n d ot her g o ver n me nt a ge ncies, e. g., t he F o o d a n d Dr u g A d mi nistrati o n ( F D A), i n v ol ve d i n kee pi n g researc h safe f or pe o ple. G o ver n me ntal a ge ncies i n ot her c o u ntries w here t he st u d y dr u g ma y be c o nsi dere d f or a p pr o val.  
Partici pati o n i n researc h ma y i n v ol ve a l oss of pri vac y, b ut i nf or mati o n a b o ut y o u will be ha n dle d as c o nfi de ntiall y as p ossi ble. A me dical rec or d will be create d beca use of y o ur partici pati o n i n t his st u d y. Y o ur c o nse nt f or m a n d s o me of y o ur researc h test res ults will be  
  
i ncl u de d i n t his rec or d. T heref ore, y o ur ot her d oct ors ma y bec o me a ware of y o ur partici pati o n.  
H os pital re g ulati o ns re q uire t hat all healt h care pr o vi ders treat i nf or mati o n i n me dical rec or ds c o nfi de ntiall y.

We will d o o ur best t o ma ke s ure t hat t he pers o nal i nf or mati o n i n y o ur me dical rec or d is ke pt pri vate. H o we ver, we ca n n ot g uara ntee t otal pri vac y. Y o ur pers o nal i nf or mati o n ma y be gi ve n o ut if re q uire d b y la w. If i nf or mati o n fr o m t his st u d y is p u blis he d or prese nte d at scie ntific meeti n gs, y o ur na me a n d ot her pers o nal i nf or mati o n will n ot be use d.  
Or ga nizati o ns t hat ma y l o o k at a n d/ or c o p y y o ur me dical rec or ds f or researc h, q ualit y ass ura nce, a n d data a nal ysis i ncl u de:  
N o vartis (t he dr u g s u p plier) a n d its a ut h orize d a ge nts Pr ostate Ca ncer F o u n dati o n T he U ni versit y of Calif or nia T he Nati o nal Ca ncer I nstit ute ( N CI) a n d ot her g o ver n me nt a ge ncies, e. g., t he F o o d a n d Dr u g A d mi nistrati o n ( F D A), i n v ol ve d i n kee pi n g researc h safe f or pe o ple. G o ver n me ntal a ge ncies i n ot her c o u ntries w here t he st u d y dr u g ma y be c o nsi dere d f or a p pr o val.  
Partici pati o n i n researc h ma y i n v ol ve a l oss of pri vac y, b ut i nf or mati o n a b o ut y o u will be ha n dle d as c o nfi de ntiall y as p ossi ble. A me dical rec or d will be create d beca use of y o ur partici pati o n i n t his st u d y. Y o ur c o nse nt f or m a n d s o me of y o ur researc h test res ults will be
i ncl u de d i n t his rec or d. T heref ore, y o ur ot her d oct ors ma y bec o me a ware of y o ur partici pati o n.  
  
H os pital re g ulati o ns re q uire t hat all healt h care pr o vi ders treat i nf or mati o n i n me dical rec or ds c o nfi de ntiall y.
Clinical trial: NCT02494921
Section: Duration of Study Involvement
Subsections: H O W M A N Y Pe O Ple Will T A Ke P Art I N T His St U D Y ?|H O W M A N Y Pe O Ple Will T A Ke P Art I N T His St U D Y ?|Bef Ore Y O U Be Gi N T He M Ai N P Art Of T He St U D Y:|Bef Ore Y O U Be Gi N T He M Ai N P Art Of T He St U D Y:|D Uri N G T He M Ai N P Art Of T He St U D Y:|D Uri N G T He M Ai N P Art Of T He St U D Y:|C Ycle 1, D A Y 1 (T His Visit Will T A Ke A B O Ut 4 H O Urs)|C Ycle 1, D A Y 1 (T His Visit Will T A Ke A B O Ut 4 H O Urs)|C Ycle 1, D A Y 2 (T His Visit Will T A Ke A B O Ut 3 0 Mi N Utes) P H Ysical E Xa Mi Nati O N|C Ycle 1, D A Y 2 (T His Visit Will T A Ke A B O Ut 3 0 Mi N Utes) P H Ysical E Xa Mi Nati O N|C Ycle 1, D A Ys 5- 7 (T His Visit S H O Ul D T A Ke A B O Ut 1 5 Mi N Utes)|C Ycle 1, D A Ys 5- 7 (T His Visit S H O Ul D T A Ke A B O Ut 1 5 Mi N Utes)|C Ycle 1, D A Y 8 (T His Visit Will T A Ke A B O Ut 1 H O Ur)|C Ycle 1, D A Y 8 (T His Visit Will T A Ke A B O Ut 1 H O Ur)|C Ycle 1, D A Y 1 5 (T His Visit Will T A Ke A B O Ut 1 H O Ur) C Ycle 2, D A Y 1 (T His Visit Will T A Ke A B O Ut 1 - 1 1/ 2 H O Urs)|C Ycle 1, D A Y 1 5 (T His Visit Will T A Ke A B O Ut 1 H O Ur) C Ycle 2, D A Y 1 (T His Visit Will T A Ke A B O Ut 1 - 1 1/ 2 H O Urs)|C Ycle 2, D A Ys 5- 7 (T His Visit S H O Ul D T A Ke A B O Ut 1 5 Mi N Utes)|C Ycle 2, D A Ys 5- 7 (T His Visit S H O Ul D T A Ke A B O Ut 1 5 Mi N Utes)|D A Y 1 Of E Ver Y C Ycle T Here After (T His Visit Will T A Ke A B O Ut 4 H O Urs)|D A Y 1 Of E Ver Y C Ycle T Here After (T His Visit Will T A Ke A B O Ut 4 H O Urs)|D A Ys 5- 7 Of E Ver Y C Ycle T Here After (T His Visit S H O Ul D T A Ke A B O Ut 1 5 Mi N Utes)|D A Ys 5- 7 Of E Ver Y C Ycle T Here After (T His Visit S H O Ul D T A Ke A B O Ut 1 5 Mi N Utes)|E N D Of Tre At Me Nt Visit (T His Visit Will T A Ke Bet Wee N 1 H O Ur A N D 5 H O Urs)|E N D Of Tre At Me Nt Visit (T His Visit Will T A Ke Bet Wee N 1 H O Ur A N D 5 H O Urs)|H O W L O N G Will I Be I N T He St U D Y ?|H O W L O N G Will I Be I N T He St U D Y ?|H O W M A N Y Pe O Ple Will T A Ke P Art I N T His St U D Y ?|H O W M A N Y Pe O Ple Will T A Ke P Art I N T His St U D Y ?|Bef Ore Y O U Be Gi N T He M Ai N P Art Of T He St U D Y:|Bef Ore Y O U Be Gi N T He M Ai N P Art Of T He St U D Y:|D Uri N G T He M Ai N P Art Of T He St U D Y:|D Uri N G T He M Ai N P Art Of T He St U D Y:|C Ycle 1, D A Y 1 (T His Visit Will T A Ke A B O Ut 4 H O Urs)|C Ycle 1, D A Y 1 (T His Visit Will T A Ke A B O Ut 4 H O Urs)|C Ycle 1, D A Y 2 (T His Visit Will T A Ke A B O Ut 3 0 Mi N Utes) P H Ysical E Xa Mi Nati O N|C Ycle 1, D A Y 2 (T His Visit Will T A Ke A B O Ut 3 0 Mi N Utes) P H Ysical E Xa Mi Nati O N|C Ycle 1, D A Ys 5- 7 (T His Visit S H O Ul D T A Ke A B O Ut 1 5 Mi N Utes)|C Ycle 1, D A Ys 5- 7 (T His Visit S H O Ul D T A Ke A B O Ut 1 5 Mi N Utes)|C Ycle 1, D A Y 8 (T His Visit Will T A Ke A B O Ut 1 H O Ur)|C Ycle 1, D A Y 8 (T His Visit Will T A Ke A B O Ut 1 H O Ur)|C Ycle 1, D A Y 1 5 (T His Visit Will T A Ke A B O Ut 1 H O Ur) C Ycle 2, D A Y 1 (T His Visit Will T A Ke A B O Ut 1 - 1 1/ 2 H O Urs)|C Ycle 1, D A Y 1 5 (T His Visit Will T A Ke A B O Ut 1 H O Ur) C Ycle 2, D A Y 1 (T His Visit Will T A Ke A B O Ut 1 - 1 1/ 2 H O Urs)|C Ycle 2, D A Ys 5- 7 (T His Visit S H O Ul D T A Ke A B O Ut 1 5 Mi N Utes)|C Ycle 2, D A Ys 5- 7 (T His Visit S H O Ul D T A Ke A B O Ut 1 5 Mi N Utes)|D A Y 1 Of E Ver Y C Ycle T Here After (T His Visit Will T A Ke A B O Ut 4 H O Urs)|D A Y 1 Of E Ver Y C Ycle T Here After (T His Visit Will T A Ke A B O Ut 4 H O Urs)|D A Ys 5- 7 Of E Ver Y C Ycle T Here After (T His Visit S H O Ul D T A Ke A B O Ut 1 5 Mi N Utes)|D A Ys 5- 7 Of E Ver Y C Ycle T Here After (T His Visit S H O Ul D T A Ke A B O Ut 1 5 Mi N Utes)|E N D Of Tre At Me Nt Visit (T His Visit Will T A Ke Bet Wee N 1 H O Ur A N D 5 H O Urs)|E N D Of Tre At Me Nt Visit (T His Visit Will T A Ke Bet Wee N 1 H O Ur A N D 5 H O Urs)|H O W L O N G Will I Be I N T He St U D Y ?|H O W L O N G Will I Be I N T He St U D Y ?

T here are t w o parts t o t his st u d y; a d ose-fi n di n g part ( p hase I b) a n d a d ose e x pa nsi o n/ p hase II  
part, y o u will o nl y be partici pati n g i n t he d ose-fi n di n g part ( p hase I b). A p pr o xi matel y 9- 1 8 patie nts will partici pate i n t he d ose-fi n di n g part ( p hase I b) at U C S F.

T here are t w o parts t o t his st u d y; a d ose-fi n di n g part ( p hase I b) a n d a d ose e x pa nsi o n/ p hase II  
part, y o u will o nl y be partici pati n g i n t he d ose-fi n di n g part ( p hase I b). A p pr o xi matel y 9- 1 8 patie nts will partici pate i n t he d ose-fi n di n g part ( p hase I b) at U C S F.

Y o u will nee d t o ha ve t he f oll o wi n g e xa ms, tests or pr oce d ures t o fi n d o ut if y o u ca n be i n t he mai n part of t he st u d y. Ma n y of t hese e xa ms, tests or pr oce d ures are part of re g ular r o uti ne ca ncer care a n d ma y be d o ne e ve n if y o u d o n ot j oi n t he st u d y. If y o u ha ve ha d s o me of t he m rece ntl y, t he y ma y n ot nee d t o be re peate d. T his will be u p t o y o ur st u d y d oct or. T he t otal ti me t o c o m plete t he scree ni n g tests a n d pr oce d ures is a b o ut 8- 1 2 h o urs. T he f oll o wi n g pr oce d ures will be d o ne:  
A c o m plete me dic al hist or y a n d y o ur c urre nt me dic al c o n diti o n will be c ollecte d i ncl u di n g i nf or mati o n a b o ut y o ur c urre nt healt h stat us P h ysical E xa mi nati o n Vit al si g ns ( bl o o d press ure, heart rate, te m perat ure), hei g ht a n d wei g ht Bl o o d s a m ples: A bl o o d sa m ple will be dra w n b y i nserti n g a nee dle i nt o a vei n i n y o ur ar m ( ~ 4 ta bles p o o ns of bl o o d):  
C o m plete bl o o d c o u nt ( C B C) wit h differe ntial a n d platelet c o u nt Bl o o d c he mistr y assess me nt P S A  
Test oster o ne T o meas ure y o ur disease, y o u will ha ve o ne or m ore of t he f oll o wi n g tests d o ne (t hese will be d o ne wit hi n 4 2 da ys of re gistrati o n):  
C T a n d/ or M RI sca n of t he c hest, a b d o me n, a n d pel vis  
  
A C T sc a n is a ra di ol o gical test t hat uses s pecial x-ra y e q ui p me nt t o ma ke detaile d pict ures of b o d y tiss ues a n d or ga ns. F or t he C T sca n, y o u ma y be gi ve n a "c o ntrast material" (a s pecial d ye t hat ma kes it easier f or d oct ors t o see differe nt tiss ues i n y o ur b o d y). T he c o ntrast material ma y be gi ve n orall y or t hr o u g h o ne of y o ur vei ns. Oral c o ntrast material is gi ve n t o y o u t o dri n k a n d is use d t o hel p o utli ne t he st o mac h a n d i ntesti nes. I ntra ve n o us (I V) c o ntrast material is gi ve n t o y o u b y i njecti n g t he c o ntrast material i nt o a li ne, w hic h is attac he d t o a nee dle i n y o ur ar m a n d is use d t o get clearer pict ures of y o ur b o d y ca vit y. After y o u ha ve bee n gi ve n t he c o ntrast material (eit her b y m o ut h, b y vei n), y o u will lie flat o n a ta ble t hat will m o ve y o u i nt o t he C T sca n mac hi ne. Y o u will be as ke d t o lie still a n d ma y be as ke d t o h ol d y o ur breat h f or a fe w sec o n ds. Eac h C T sca n will ta ke a b o ut 1 5 mi n utes t o a half h o ur.  
If a C T sca n ca n n ot be perf or me d, a n M RI sc a n will be perf or me d. A n M RI sca n ta kes a n i ma ge of y o ur b o d y t o o bser ve t he l ocati o n a n d size of y o ur t u m or. F or t he M RI  
sca n, y o u ma y be gi ve n a "c o ntrast material" (a s pecial d ye t hat ma kes it easier f or d oct ors t o see differe nt tiss ues i n y o ur b o d y). Ga d oli ni u m is c o ntrast material t hat ca uses s o me t u m ors t o a p pear m uc h bri g hter t ha n n or mal tiss ue o n M RI sca ns t hese t u m ors ma y n ot be visi ble wit h o ut ga d oli ni u m). T he c o ntrast material ma y be gi ve n t o y o u i n y o ur ar m t hr o u g h a cat heter (a ti n y t u be) i nserte d i nt o a vei n. Y o u will t he n lie d o w n o n a narr o w be d, w hic h will be place d i n a t u n nel t hat is 6 feet l o n g b y 2 2 i nc hes wi de a n d o pe n at eac h e n d. Y o u will lie t here q uietl y f or a b o ut o ne h o ur, d uri n g w hic h ti me y o u will hear a l o u d mac hi ne- li ke n oise. T he M RI sca n is d o ne i n t he Ra di ol o g y De part me nt a n d ta kes a p pr o xi matel y a n h o ur a n d a half t o c o m plete.  
B o ne sc a n: A b o ne sca n is a test t hat ma kes detaile d i ma ges of y o ur b o nes a n d a n y t u m ors o n t he m. Bef ore t he b o ne sca n, a s mall a m o u nt of ra di oacti ve s u bsta nce is i njecte d i nt o y o ur vei n. A b o ut 3 h o urs later, y o u will lie o n a ta ble u n der a mac hi ne, w hic h will ma ke a n i ma ge of y o ur b o nes. T he test itself will ta ke a b o ut 1 h o ur, b ut t he w h ole pr ocess ta kes u p t o 4 h o urs.  
Electr oc ar di o gr a m ( E C G): rec or ds t he electrical acti vit y of y o ur heart. Wires or "lea ds" will be attac he d t o y o ur c hest wit h a n a d hesi ve a n d y o u will be as ke d t o lie still w hile t he mac hi ne pri nts o ut a n electrical "rec or d" of y o ur heart acti vit y. T he pr oce d ure is d o ne i n t he Car di ol o g y De part me nt a n d ta kes a b o ut 1 5- 3 0 mi n utes.  
Y o u will be as ke d a b o ut a n y me dici nes y o u are ta ki n g i ncl u di n g o ver-t he-c o u nter me dici nes, vita mi ns, or her bal treat me nts.  
Perf or m a nce st at us t o assess h o w y o ur disease is affecti n g y o ur dail y acti vities.  
Eit her a M U G A ( m ulti ple- gate d ac q uisiti o n) sca n or a n E C H O (ec h ocar di o gra m), n o ni n vasi ve tests w hic h ta ke m o vi n g pict ures of y o ur heart will als o be d o ne. T hese will be d o ne wit hi n 4 2 of re gistrati o n.  
M U G A sc a n : A M U G A sca n is a test t hat ma kes a m oti o n pict ure t hat s h o ws h o w well y o ur heart p u m ps bl o o d. T he sca n is perf or me d b y ta ki n g a s mall sa m ple of  
  
y o ur o w n bl o o d t hat is t he n "la bele d" wit h a ra di oacti ve s u bsta nce. T he la bele d bl o o d sa m ple is t he n re-i njecte d i nt o a vei n i n y o ur ar m a n d all o we d t o circ ulate i n y o ur b o d y. O nce t he la bele d bl o o d has circ ulate d ar o u n d y o ur b o d y, a series of i ma ges (si milar t o a m o vie) are ta ke n of y o ur heart. Y o u will be as ke d t o lie flat o n a ta ble a n d re mai n still f or a b o ut 1 0- 2 0 mi n utes w hile t he pict ures of y o ur heart are bei n g ta ke n. T his test is d o ne i n t he N uclear Me dici ne de part me nt a n d ta kes a b o ut 9 0 mi n utes.  
E C H O : T his e xa mi nati o n uses s o u n d wa ves t o ma ke pict ures of y o ur heart, w hic h hel ps deter mi ne h o w well y o ur heart s q ueezes bl o o d. Y o u will be as ke d t o lie o n y o ur left si de w hile a tec h nicia n places a pr o be wit h gel o n y o ur c hest t o create i ma ges of y o ur heart t o deter mi ne t he f u ncti o n a n d size. T he pr oce d ure is d o ne i n t he Car di ol o g y De part me nt a n d will ta ke a p pr o xi matel y 4 5- 6 0 mi n utes.

Y o u will nee d t o ha ve t he f oll o wi n g e xa ms, tests or pr oce d ures t o fi n d o ut if y o u ca n be i n t he mai n part of t he st u d y. Ma n y of t hese e xa ms, tests or pr oce d ures are part of re g ular r o uti ne ca ncer care a n d ma y be d o ne e ve n if y o u d o n ot j oi n t he st u d y. If y o u ha ve ha d s o me of t he m rece ntl y, t he y ma y n ot nee d t o be re peate d. T his will be u p t o y o ur st u d y d oct or. T he t otal ti me t o c o m plete t he scree ni n g tests a n d pr oce d ures is a b o ut 8- 1 2 h o urs. T he f oll o wi n g pr oce d ures will be d o ne:  
A c o m plete me dic al hist or y a n d y o ur c urre nt me dic al c o n diti o n will be c ollecte d i ncl u di n g i nf or mati o n a b o ut y o ur c urre nt healt h stat us P h ysical E xa mi nati o n Vit al si g ns ( bl o o d press ure, heart rate, te m perat ure), hei g ht a n d wei g ht Bl o o d s a m ples: A bl o o d sa m ple will be dra w n b y i nserti n g a nee dle i nt o a vei n i n y o ur ar m ( ~ 4 ta bles p o o ns of bl o o d):  
C o m plete bl o o d c o u nt ( C B C) wit h differe ntial a n d platelet c o u nt Bl o o d c he mistr y assess me nt P S A  
Test oster o ne T o meas ure y o ur disease, y o u will ha ve o ne or m ore of t he f oll o wi n g tests d o ne (t hese will be d o ne wit hi n 4 2 da ys of re gistrati o n):  
C T a n d/ or M RI sca n of t he c hest, a b d o me n, a n d pel vis A C T sc a n is a ra di ol o gical test t hat uses s pecial x-ra y e q ui p me nt t o ma ke detaile d  
  
pict ures of b o d y tiss ues a n d or ga ns. F or t he C T sca n, y o u ma y be gi ve n a "c o ntrast material" (a s pecial d ye t hat ma kes it easier f or d oct ors t o see differe nt tiss ues i n y o ur b o d y). T he c o ntrast material ma y be gi ve n orall y or t hr o u g h o ne of y o ur vei ns. Oral c o ntrast material is gi ve n t o y o u t o dri n k a n d is use d t o hel p o utli ne t he st o mac h a n d i ntesti nes. I ntra ve n o us (I V) c o ntrast material is gi ve n t o y o u b y i njecti n g t he c o ntrast material i nt o a li ne, w hic h is attac he d t o a nee dle i n y o ur ar m a n d is use d t o get clearer pict ures of y o ur b o d y ca vit y. After y o u ha ve bee n gi ve n t he c o ntrast material (eit her b y m o ut h, b y vei n), y o u will lie flat o n a ta ble t hat will m o ve y o u i nt o t he C T sca n mac hi ne. Y o u will be as ke d t o lie still a n d ma y be as ke d t o h ol d y o ur breat h f or a fe w sec o n ds. Eac h C T sca n will ta ke a b o ut 1 5 mi n utes t o a half h o ur.  
If a C T sca n ca n n ot be perf or me d, a n M RI sc a n will be perf or me d. A n M RI sca n ta kes a n i ma ge of y o ur b o d y t o o bser ve t he l ocati o n a n d size of y o ur t u m or. F or t he M RI  
sca n, y o u ma y be gi ve n a "c o ntrast material" (a s pecial d ye t hat ma kes it easier f or d oct ors t o see differe nt tiss ues i n y o ur b o d y). Ga d oli ni u m is c o ntrast material t hat ca uses s o me t u m ors t o a p pear m uc h bri g hter t ha n n or mal tiss ue o n M RI sca ns t hese t u m ors ma y n ot be visi ble wit h o ut ga d oli ni u m). T he c o ntrast material ma y be gi ve n t o y o u i n y o ur ar m t hr o u g h a cat heter (a ti n y t u be) i nserte d i nt o a vei n. Y o u will t he n lie d o w n o n a narr o w be d, w hic h will be place d i n a t u n nel t hat is 6 feet l o n g b y 2 2 i nc hes wi de a n d o pe n at eac h e n d. Y o u will lie t here q uietl y f or a b o ut o ne h o ur, d uri n g w hic h ti me y o u will hear a l o u d mac hi ne- li ke n oise. T he M RI sca n is d o ne i n t he Ra di ol o g y De part me nt a n d ta kes a p pr o xi matel y a n h o ur a n d a half t o c o m plete.  
B o ne sc a n: A b o ne sca n is a test t hat ma kes detaile d i ma ges of y o ur b o nes a n d a n y t u m ors o n t he m. Bef ore t he b o ne sca n, a s mall a m o u nt of ra di oacti ve s u bsta nce is i njecte d i nt o y o ur vei n. A b o ut 3 h o urs later, y o u will lie o n a ta ble u n der a mac hi ne, w hic h will ma ke a n i ma ge of y o ur b o nes. T he test itself will ta ke a b o ut 1 h o ur, b ut t he w h ole pr ocess ta kes u p t o 4 h o urs.  
Electr oc ar di o gr a m ( E C G): rec or ds t he electrical acti vit y of y o ur heart. Wires or "lea ds" will be attac he d t o y o ur c hest wit h a n a d hesi ve a n d y o u will be as ke d t o lie still w hile t he mac hi ne pri nts o ut a n electrical "rec or d" of y o ur heart acti vit y. T he pr oce d ure is d o ne i n t he Car di ol o g y De part me nt a n d ta kes a b o ut 1 5- 3 0 mi n utes.  
Y o u will be as ke d a b o ut a n y me dici nes y o u are ta ki n g i ncl u di n g o ver-t he-c o u nter me dici nes, vita mi ns, or her bal treat me nts.  
Perf or m a nce st at us t o assess h o w y o ur disease is affecti n g y o ur dail y acti vities.  
Eit her a M U G A ( m ulti ple- gate d ac q uisiti o n) sca n or a n E C H O (ec h ocar di o gra m), n o ni n vasi ve tests w hic h ta ke m o vi n g pict ures of y o ur heart will als o be d o ne. T hese will be d o ne wit hi n 4 2 of re gistrati o n.  
M U G A sc a n : A M U G A sca n is a test t hat ma kes a m oti o n pict ure t hat s h o ws h o w well y o ur heart p u m ps bl o o d. T he sca n is perf or me d b y ta ki n g a s mall sa m ple of y o ur o w n bl o o d t hat is t he n "la bele d" wit h a ra di oacti ve s u bsta nce. T he la bele d  
  
bl o o d sa m ple is t he n re-i njecte d i nt o a vei n i n y o ur ar m a n d all o we d t o circ ulate i n y o ur b o d y. O nce t he la bele d bl o o d has circ ulate d ar o u n d y o ur b o d y, a series of i ma ges (si milar t o a m o vie) are ta ke n of y o ur heart. Y o u will be as ke d t o lie flat o n a ta ble a n d re mai n still f or a b o ut 1 0- 2 0 mi n utes w hile t he pict ures of y o ur heart are bei n g ta ke n. T his test is d o ne i n t he N uclear Me dici ne de part me nt a n d ta kes a b o ut 9 0 mi n utes.  
E C H O : T his e xa mi nati o n uses s o u n d wa ves t o ma ke pict ures of y o ur heart, w hic h hel ps deter mi ne h o w well y o ur heart s q ueezes bl o o d. Y o u will be as ke d t o lie o n y o ur left si de w hile a tec h nicia n places a pr o be wit h gel o n y o ur c hest t o create i ma ges of y o ur heart t o deter mi ne t he f u ncti o n a n d size. T he pr oce d ure is d o ne i n t he Car di ol o g y De part me nt a n d will ta ke a p pr o xi matel y 4 5- 6 0 mi n utes.

If t he e xa ms, tests, a n d pr oce d ures s h o w t hat meet t he criteria t o be i n t he researc h st u d y a n d y o u c h o ose t o ta ke part, y o u will t he n be e nr olle d i n t he researc h st u d y. Eac h c ycle of treat me nt will last 2 1 da ys.

If t he e xa ms, tests, a n d pr oce d ures s h o w t hat meet t he criteria t o be i n t he researc h st u d y a n d y o u c h o ose t o ta ke part, y o u will t he n be e nr olle d i n t he researc h st u d y. Eac h c ycle of treat me nt will last 2 1 da ys.

P h ysical E xa mi nati o n Vital si g ns ( bl o o d press ure, heart rate, te m perat ure), hei g ht, a n d wei g ht Bl o o d sa m ples ( ~ 2 ta bles p o o ns of bl o o d):  
Bl o o d c o u nts R o uti ne tests f or safet y P S A  
A d mi nistrati o n of d oceta xel t hr o u g h o ne of y o ur vei ns Start ta ki n g oral pre d nis o ne t wice dail y Re vie w of si de effects Perf or ma nce stat us C o nc urre nt me dicati o ns First oral d ose of ri b ocicli b Bl o o d sa m ples ( ~ 1 ta bles p o o n of bl o o d):  
P har mac o ki netics - T hese are bl o o d tests t hat will hel p deter mi ne t he le vels of st u d y dr u g i n y o ur bl o o d at differe nt ti me p oi nts.

P h ysical E xa mi nati o n Vital si g ns ( bl o o d press ure, heart rate, te m perat ure), hei g ht, a n d wei g ht Bl o o d sa m ples ( ~ 2 ta bles p o o ns of bl o o d):  
Bl o o d c o u nts R o uti ne tests f or safet y P S A  
A d mi nistrati o n of d oceta xel t hr o u g h o ne of y o ur vei ns Start ta ki n g oral pre d nis o ne t wice dail y Re vie w of si de effects Perf or ma nce stat us C o nc urre nt me dicati o ns First oral d ose of ri b ocicli b Bl o o d sa m ples ( ~ 1 ta bles p o o n of bl o o d):  
P har mac o ki netics - T hese are bl o o d tests t hat will hel p deter mi ne t he le vels of st u d y dr u g i n y o ur bl o o d at differe nt ti me p oi nts.

Vital si g ns ( bl o o d press ure, heart rate, te m perat ure)  
Re vie w of si de effects P a g e 5 of 2 5 C C \# 1 4 5 5 1 5  
  
```
Perf or ma nce stat us

Bl o o d sa m ples ( ~ 1 ta bles p o o n of bl o o d):

P har mac o ki netics - T hese are bl o o d tests t hat will hel p deter mi ne t he le vels of

st u d y dr u g i n y o ur bl o o d at differe nt ti me p oi nts.


```

Vital si g ns ( bl o o d press ure, heart rate, te m perat ure)  
Re vie w of si de effects P a g e 5 of 2 5 C C \# 1 4 5 5 1 5  
```
Perf or ma nce stat us

Bl o o d sa m ples ( ~ 1 ta bles p o o n of bl o o d):

P har mac o ki netics - T hese are bl o o d tests t hat will hel p deter mi ne t he le vels of

st u d y dr u g i n y o ur bl o o d at differe nt ti me p oi nts.




```

Ne u p o ge n a d mi nistrati o n - gi ve n u n der t he s ki n dail y o n Da ys 5- 7. T hese i njecti o ns will be a d mi nistere d eit her at h o me or i n t he cli nic.

Ne u p o ge n a d mi nistrati o n - gi ve n u n der t he s ki n dail y o n Da ys 5- 7. T hese i njecti o ns will be a d mi nistere d eit her at h o me or i n t he cli nic.

P h ysical E xa mi nati o n Vital si g ns ( bl o o d press ure, heart rate, te m perat ure)  
Bl o o d sa m ples ( ~ 2 ta bles p o o ns of bl o o d):  
Bl o o d c o u nts R o uti ne tests f or safet y Re vie w of si de effects Perf or ma nce stat us C o nc urre nt me dicati o ns

P h ysical E xa mi nati o n Vital si g ns ( bl o o d press ure, heart rate, te m perat ure)  
Bl o o d sa m ples ( ~ 2 ta bles p o o ns of bl o o d):  
Bl o o d c o u nts R o uti ne tests f or safet y Re vie w of si de effects Perf or ma nce stat us C o nc urre nt me dicati o ns

P h ysical E xa mi nati o n Vital si g ns ( bl o o d press ure, heart rate, te m perat ure), hei g ht, a n d wei g ht Electr ocar di o gra m ( E C G)  
Bl o o d sa m ples ( ~ 2 ta bles p o o ns of bl o o d):  
Bl o o d c o u nts P a g e 6 of 2 5 C C \# 1 4 5 5 1 5 P h ysical E xa mi nati o n Vital si g ns ( bl o o d press ure, heart rate, te m perat ure)  
Electr ocar di o gra m ( E C G)  
Bl o o d sa m ples ( ~ 1 ta bles p o o n of bl o o d):  
Bl o o d c o u nts Re vie w of si de effects Perf or ma nce stat us C o nc urre nt me dicati o ns  
  
R o uti ne tests f or safet y P S A  
A d mi nistrati o n of d oceta xel t hr o u g h o ne of y o ur vei ns Re vie w of si de effects Perf or ma nce stat us C o nc urre nt me dicati o ns

P h ysical E xa mi nati o n Vital si g ns ( bl o o d press ure, heart rate, te m perat ure), hei g ht, a n d wei g ht Electr ocar di o gra m ( E C G)  
Bl o o d sa m ples ( ~ 2 ta bles p o o ns of bl o o d):  
Bl o o d c o u nts P a g e 6 of 2 5 C C \# 1 4 5 5 1 5 P h ysical E xa mi nati o n Vital si g ns ( bl o o d press ure, heart rate, te m perat ure)  
Electr ocar di o gra m ( E C G)  
Bl o o d sa m ples ( ~ 1 ta bles p o o n of bl o o d):  
Bl o o d c o u nts Re vie w of si de effects Perf or ma nce stat us C o nc urre nt me dicati o ns R o uti ne tests f or safet y  
  
P S A  
A d mi nistrati o n of d oceta xel t hr o u g h o ne of y o ur vei ns Re vie w of si de effects Perf or ma nce stat us C o nc urre nt me dicati o ns

Ne u p o ge n a d mi nistrati o n - gi ve n u n der t he s ki n dail y o n Da ys 5- 7. T hese i njecti o ns will be a d mi nistere d eit her at h o me or i n t he cli nic.

Ne u p o ge n a d mi nistrati o n - gi ve n u n der t he s ki n dail y o n Da ys 5- 7. T hese i njecti o ns will be a d mi nistere d eit her at h o me or i n t he cli nic.

P h ysical E xa mi nati o n Vital si g ns ( bl o o d press ure, heart rate, te m perat ure), hei g ht, a n d wei g ht Bl o o d sa m ples ( ~ 2 ta bles p o o ns of bl o o d):  
Bl o o d c o u nts R o uti ne tests f or safet y P S A  
A d mi nistrati o n of d oceta xel t hr o u g h o ne of y o ur vei ns Re vie w of si de effects Electr ocar di o gra m ( E C G)  
Perf or ma nce stat us C o nc urre nt me dicati o ns

P h ysical E xa mi nati o n Vital si g ns ( bl o o d press ure, heart rate, te m perat ure), hei g ht, a n d wei g ht Bl o o d sa m ples ( ~ 2 ta bles p o o ns of bl o o d):  
Bl o o d c o u nts R o uti ne tests f or safet y P S A  
A d mi nistrati o n of d oceta xel t hr o u g h o ne of y o ur vei ns Re vie w of si de effects Electr ocar di o gra m ( E C G)  
Perf or ma nce stat us C o nc urre nt me dicati o ns

Ne u p o ge n a d mi nistrati o n - gi ve n u n der t he s ki n dail y o n Da ys 5- 7. T hese i njecti o ns will  
be a d mi nistere d eit her at h o me or i n t he cli nic.

Ne u p o ge n a d mi nistrati o n - gi ve n u n der t he s ki n dail y o n Da ys 5- 7. T hese i njecti o ns will  
be a d mi nistere d eit her at h o me or i n t he cli nic.

D uri n g t his visit, y o u will ha ve t he f oll o wi n g e xa ms, tests, or pr oce d ures at t he ti me, as s pecifie d. T he visit will be d o ne wit hi n 3 0 da ys of t he last treat me nt.  
P h ysical E xa mi nati o n Vital si g ns ( bl o o d press ure, heart rate, te m perat ure), hei g ht, a n d wei g ht Bl o o d sa m ples ( ~ 2 ta bles p o o ns of bl o o d):  
Bl o o d c o u nts R o uti ne tests f or safet y P S A  
Re vie w of si de effects Perf or ma nce stat us C o nc urre nt me dicati o ns C T or M RI of t he c hest/a b d o me n/ pel vis (if n ot alrea d y c o m plete d wit hi n past 2 8 da ys)  
B o ne sca n (if n ot alrea d y c o m plete d wit hi n past 2 8 da ys)  
Y o u will be c o nt acte d 3 0 d a ys after t he l ast d ose of st u d y tre at me nt . Y o u will be as ke d h o w y o u are feeli n g a n d w hat me dicati o ns y o u ha ve bee n ta ki n g.  
If y o u wit h dr a w fr o m t he st u d y, a n d y o ur disease has n ot pr o gresse d, y o u ma y be c o ntacte d via a p h o ne call, a n d as ke d t o ha ve a C T/ M RI sca n d o ne e ver y t w o m o nt hs t o meas ure y o ur disease si nce st o p pi n g st u d y treat me nt. T his will be d o ne f or researc h p ur p oses if t his sca n is d o ne at a ti me p oi nt ot her t ha n y o ur r o uti ne resta gi n g ti me p oi nt.

D uri n g t his visit, y o u will ha ve t he f oll o wi n g e xa ms, tests, or pr oce d ures at t he ti me, as s pecifie d. T he visit will be d o ne wit hi n 3 0 da ys of t he last treat me nt.  
P h ysical E xa mi nati o n  
  
Vital si g ns ( bl o o d press ure, heart rate, te m perat ure), hei g ht, a n d wei g ht Bl o o d sa m ples ( ~ 2 ta bles p o o ns of bl o o d):  
Bl o o d c o u nts R o uti ne tests f or safet y P S A  
Re vie w of si de effects Perf or ma nce stat us C o nc urre nt me dicati o ns C T or M RI of t he c hest/a b d o me n/ pel vis (if n ot alrea d y c o m plete d wit hi n past 2 8 da ys)  
B o ne sca n (if n ot alrea d y c o m plete d wit hi n past 2 8 da ys)  
Y o u will be c o nt acte d 3 0 d a ys after t he l ast d ose of st u d y tre at me nt . Y o u will be as ke d h o w y o u are feeli n g a n d w hat me dicati o ns y o u ha ve bee n ta ki n g.  
If y o u wit h dr a w fr o m t he st u d y, a n d y o ur disease has n ot pr o gresse d, y o u ma y be c o ntacte d via a p h o ne call, a n d as ke d t o ha ve a C T/ M RI sca n d o ne e ver y t w o m o nt hs t o meas ure y o ur disease si nce st o p pi n g st u d y treat me nt. T his will be d o ne f or researc h p ur p oses if t his sca n is d o ne at a ti me p oi nt ot her t ha n y o ur r o uti ne resta gi n g ti me p oi nt.

Y o u will c o nti n ue st u d y treat me nt u ntil y o u e x perie nce disease pr o gressi o n, disc o nti n ue treat me nt d ue t o i nt olera ble t o xicit y, i n vesti gat or decisi o n, or wit h dra w c o nse nt, w hic he ver occ urs first. Y o u will be treate d wit h t he c o m bi nati o n of ri b ocicli b pl us d oceta xel + pre d nis o ne f or u p t o 9 c ycles. If t here is n o e vi de nce of disease pr o gressi o n after 9 c ycles of pr ot oc ol t hera p y, patie nts ma y c o nti n ue o n si n gle a ge nt mai nte na nce ri b ocicli b u ntil t he ti me of disease pr o gressi o n.  
Y o ur d oct or ca n als o deci de t o wit h dra w y o u fr o m t he st u d y if he/s he feels t hat t his is best f or y o u.

Y o u will c o nti n ue st u d y treat me nt u ntil y o u e x perie nce disease pr o gressi o n, disc o nti n ue treat me nt d ue t o i nt olera ble t o xicit y, i n vesti gat or decisi o n, or wit h dra w c o nse nt, w hic he ver occ urs first. Y o u will be treate d wit h t he c o m bi nati o n of ri b ocicli b pl us d oceta xel + pre d nis o ne f or u p t o 9 c ycles. If t here is n o e vi de nce of disease pr o gressi o n after 9 c ycles of pr ot oc ol t hera p y, patie nts ma y c o nti n ue o n si n gle a ge nt mai nte na nce ri b ocicli b u ntil t he ti me of disease pr o gressi o n.  
Y o ur d oct or ca n als o deci de t o wit h dra w y o u fr o m t he st u d y if he/s he feels t hat t his is best f or y o u.

T here are t w o parts t o t his st u d y; a d ose-fi n di n g part ( p hase I b) a n d a d ose e x pa nsi o n/ p hase II  
part, y o u will o nl y be partici pati n g i n t he d ose-fi n di n g part ( p hase I b). A p pr o xi matel y 9- 1 8 patie nts will partici pate i n t he d ose-fi n di n g part ( p hase I b) at U C S F.

T here are t w o parts t o t his st u d y; a d ose-fi n di n g part ( p hase I b) a n d a d ose e x pa nsi o n/ p hase II  
part, y o u will o nl y be partici pati n g i n t he d ose-fi n di n g part ( p hase I b). A p pr o xi matel y 9- 1 8 patie nts will partici pate i n t he d ose-fi n di n g part ( p hase I b) at U C S F.

Y o u will nee d t o ha ve t he f oll o wi n g e xa ms, tests or pr oce d ures t o fi n d o ut if y o u ca n be i n t he mai n part of t he st u d y. Ma n y of t hese e xa ms, tests or pr oce d ures are part of re g ular r o uti ne ca ncer care a n d ma y be d o ne e ve n if y o u d o n ot j oi n t he st u d y. If y o u ha ve ha d s o me of t he m rece ntl y, t he y ma y n ot nee d t o be re peate d. T his will be u p t o y o ur st u d y d oct or. T he t otal ti me t o c o m plete t he scree ni n g tests a n d pr oce d ures is a b o ut 8- 1 2 h o urs. T he f oll o wi n g pr oce d ures will be d o ne:  
A c o m plete me dic al hist or y a n d y o ur c urre nt me dic al c o n diti o n will be c ollecte d i ncl u di n g i nf or mati o n a b o ut y o ur c urre nt healt h stat us P h ysical E xa mi nati o n Vit al si g ns ( bl o o d press ure, heart rate, te m perat ure), hei g ht a n d wei g ht Bl o o d s a m ples: A bl o o d sa m ple will be dra w n b y i nserti n g a nee dle i nt o a vei n i n y o ur ar m ( ~ 4 ta bles p o o ns of bl o o d):  
C o m plete bl o o d c o u nt ( C B C) wit h differe ntial a n d platelet c o u nt Bl o o d c he mistr y assess me nt P S A  
Test oster o ne T o meas ure y o ur disease, y o u will ha ve o ne or m ore of t he f oll o wi n g tests d o ne (t hese will be d o ne wit hi n 4 2 da ys of re gistrati o n):  
C T a n d/ or M RI sca n of t he c hest, a b d o me n, a n d pel vis  
  
A C T sc a n is a ra di ol o gical test t hat uses s pecial x-ra y e q ui p me nt t o ma ke detaile d pict ures of b o d y tiss ues a n d or ga ns. F or t he C T sca n, y o u ma y be gi ve n a "c o ntrast material" (a s pecial d ye t hat ma kes it easier f or d oct ors t o see differe nt tiss ues i n y o ur b o d y). T he c o ntrast material ma y be gi ve n orall y or t hr o u g h o ne of y o ur vei ns. Oral c o ntrast material is gi ve n t o y o u t o dri n k a n d is use d t o hel p o utli ne t he st o mac h a n d i ntesti nes. I ntra ve n o us (I V) c o ntrast material is gi ve n t o y o u b y i njecti n g t he c o ntrast material i nt o a li ne, w hic h is attac he d t o a nee dle i n y o ur ar m a n d is use d t o get clearer pict ures of y o ur b o d y ca vit y. After y o u ha ve bee n gi ve n t he c o ntrast material (eit her b y m o ut h, b y vei n), y o u will lie flat o n a ta ble t hat will m o ve y o u i nt o t he C T sca n mac hi ne. Y o u will be as ke d t o lie still a n d ma y be as ke d t o h ol d y o ur breat h f or a fe w sec o n ds. Eac h C T sca n will ta ke a b o ut 1 5 mi n utes t o a half h o ur.  
If a C T sca n ca n n ot be perf or me d, a n M RI sc a n will be perf or me d. A n M RI sca n ta kes a n i ma ge of y o ur b o d y t o o bser ve t he l ocati o n a n d size of y o ur t u m or. F or t he M RI  
sca n, y o u ma y be gi ve n a "c o ntrast material" (a s pecial d ye t hat ma kes it easier f or d oct ors t o see differe nt tiss ues i n y o ur b o d y). Ga d oli ni u m is c o ntrast material t hat ca uses s o me t u m ors t o a p pear m uc h bri g hter t ha n n or mal tiss ue o n M RI sca ns t hese t u m ors ma y n ot be visi ble wit h o ut ga d oli ni u m). T he c o ntrast material ma y be gi ve n t o y o u i n y o ur ar m t hr o u g h a cat heter (a ti n y t u be) i nserte d i nt o a vei n. Y o u will t he n lie d o w n o n a narr o w be d, w hic h will be place d i n a t u n nel t hat is 6 feet l o n g b y 2 2 i nc hes wi de a n d o pe n at eac h e n d. Y o u will lie t here q uietl y f or a b o ut o ne h o ur, d uri n g w hic h ti me y o u will hear a l o u d mac hi ne- li ke n oise. T he M RI sca n is d o ne i n t he Ra di ol o g y De part me nt a n d ta kes a p pr o xi matel y a n h o ur a n d a half t o c o m plete.  
B o ne sc a n: A b o ne sca n is a test t hat ma kes detaile d i ma ges of y o ur b o nes a n d a n y t u m ors o n t he m. Bef ore t he b o ne sca n, a s mall a m o u nt of ra di oacti ve s u bsta nce is i njecte d i nt o y o ur vei n. A b o ut 3 h o urs later, y o u will lie o n a ta ble u n der a mac hi ne, w hic h will ma ke a n i ma ge of y o ur b o nes. T he test itself will ta ke a b o ut 1 h o ur, b ut t he w h ole pr ocess ta kes u p t o 4 h o urs.  
Electr oc ar di o gr a m ( E C G): rec or ds t he electrical acti vit y of y o ur heart. Wires or "lea ds" will be attac he d t o y o ur c hest wit h a n a d hesi ve a n d y o u will be as ke d t o lie still w hile t he mac hi ne pri nts o ut a n electrical "rec or d" of y o ur heart acti vit y. T he pr oce d ure is d o ne i n t he Car di ol o g y De part me nt a n d ta kes a b o ut 1 5- 3 0 mi n utes.  
Y o u will be as ke d a b o ut a n y me dici nes y o u are ta ki n g i ncl u di n g o ver-t he-c o u nter me dici nes, vita mi ns, or her bal treat me nts.  
Perf or m a nce st at us t o assess h o w y o ur disease is affecti n g y o ur dail y acti vities.  
Eit her a M U G A ( m ulti ple- gate d ac q uisiti o n) sca n or a n E C H O (ec h ocar di o gra m), n o ni n vasi ve tests w hic h ta ke m o vi n g pict ures of y o ur heart will als o be d o ne. T hese will be d o ne wit hi n 4 2 of re gistrati o n.  
M U G A sc a n : A M U G A sca n is a test t hat ma kes a m oti o n pict ure t hat s h o ws h o w well y o ur heart p u m ps bl o o d. T he sca n is perf or me d b y ta ki n g a s mall sa m ple of  
  
y o ur o w n bl o o d t hat is t he n "la bele d" wit h a ra di oacti ve s u bsta nce. T he la bele d bl o o d sa m ple is t he n re-i njecte d i nt o a vei n i n y o ur ar m a n d all o we d t o circ ulate i n y o ur b o d y. O nce t he la bele d bl o o d has circ ulate d ar o u n d y o ur b o d y, a series of i ma ges (si milar t o a m o vie) are ta ke n of y o ur heart. Y o u will be as ke d t o lie flat o n a ta ble a n d re mai n still f or a b o ut 1 0- 2 0 mi n utes w hile t he pict ures of y o ur heart are bei n g ta ke n. T his test is d o ne i n t he N uclear Me dici ne de part me nt a n d ta kes a b o ut 9 0 mi n utes.  
E C H O : T his e xa mi nati o n uses s o u n d wa ves t o ma ke pict ures of y o ur heart, w hic h hel ps deter mi ne h o w well y o ur heart s q ueezes bl o o d. Y o u will be as ke d t o lie o n y o ur left si de w hile a tec h nicia n places a pr o be wit h gel o n y o ur c hest t o create i ma ges of y o ur heart t o deter mi ne t he f u ncti o n a n d size. T he pr oce d ure is d o ne i n t he Car di ol o g y De part me nt a n d will ta ke a p pr o xi matel y 4 5- 6 0 mi n utes.

Y o u will nee d t o ha ve t he f oll o wi n g e xa ms, tests or pr oce d ures t o fi n d o ut if y o u ca n be i n t he mai n part of t he st u d y. Ma n y of t hese e xa ms, tests or pr oce d ures are part of re g ular r o uti ne ca ncer care a n d ma y be d o ne e ve n if y o u d o n ot j oi n t he st u d y. If y o u ha ve ha d s o me of t he m rece ntl y, t he y ma y n ot nee d t o be re peate d. T his will be u p t o y o ur st u d y d oct or. T he t otal ti me t o c o m plete t he scree ni n g tests a n d pr oce d ures is a b o ut 8- 1 2 h o urs. T he f oll o wi n g pr oce d ures will be d o ne:  
A c o m plete me dic al hist or y a n d y o ur c urre nt me dic al c o n diti o n will be c ollecte d i ncl u di n g i nf or mati o n a b o ut y o ur c urre nt healt h stat us P h ysical E xa mi nati o n Vit al si g ns ( bl o o d press ure, heart rate, te m perat ure), hei g ht a n d wei g ht Bl o o d s a m ples: A bl o o d sa m ple will be dra w n b y i nserti n g a nee dle i nt o a vei n i n y o ur ar m ( ~ 4 ta bles p o o ns of bl o o d):  
C o m plete bl o o d c o u nt ( C B C) wit h differe ntial a n d platelet c o u nt Bl o o d c he mistr y assess me nt P S A  
Test oster o ne T o meas ure y o ur disease, y o u will ha ve o ne or m ore of t he f oll o wi n g tests d o ne (t hese will be d o ne wit hi n 4 2 da ys of re gistrati o n):  
C T a n d/ or M RI sca n of t he c hest, a b d o me n, a n d pel vis A C T sc a n is a ra di ol o gical test t hat uses s pecial x-ra y e q ui p me nt t o ma ke detaile d  
  
pict ures of b o d y tiss ues a n d or ga ns. F or t he C T sca n, y o u ma y be gi ve n a "c o ntrast material" (a s pecial d ye t hat ma kes it easier f or d oct ors t o see differe nt tiss ues i n y o ur b o d y). T he c o ntrast material ma y be gi ve n orall y or t hr o u g h o ne of y o ur vei ns. Oral c o ntrast material is gi ve n t o y o u t o dri n k a n d is use d t o hel p o utli ne t he st o mac h a n d i ntesti nes. I ntra ve n o us (I V) c o ntrast material is gi ve n t o y o u b y i njecti n g t he c o ntrast material i nt o a li ne, w hic h is attac he d t o a nee dle i n y o ur ar m a n d is use d t o get clearer pict ures of y o ur b o d y ca vit y. After y o u ha ve bee n gi ve n t he c o ntrast material (eit her b y m o ut h, b y vei n), y o u will lie flat o n a ta ble t hat will m o ve y o u i nt o t he C T sca n mac hi ne. Y o u will be as ke d t o lie still a n d ma y be as ke d t o h ol d y o ur breat h f or a fe w sec o n ds. Eac h C T sca n will ta ke a b o ut 1 5 mi n utes t o a half h o ur.  
If a C T sca n ca n n ot be perf or me d, a n M RI sc a n will be perf or me d. A n M RI sca n ta kes a n i ma ge of y o ur b o d y t o o bser ve t he l ocati o n a n d size of y o ur t u m or. F or t he M RI  
sca n, y o u ma y be gi ve n a "c o ntrast material" (a s pecial d ye t hat ma kes it easier f or d oct ors t o see differe nt tiss ues i n y o ur b o d y). Ga d oli ni u m is c o ntrast material t hat ca uses s o me t u m ors t o a p pear m uc h bri g hter t ha n n or mal tiss ue o n M RI sca ns t hese t u m ors ma y n ot be visi ble wit h o ut ga d oli ni u m). T he c o ntrast material ma y be gi ve n t o y o u i n y o ur ar m t hr o u g h a cat heter (a ti n y t u be) i nserte d i nt o a vei n. Y o u will t he n lie d o w n o n a narr o w be d, w hic h will be place d i n a t u n nel t hat is 6 feet l o n g b y 2 2 i nc hes wi de a n d o pe n at eac h e n d. Y o u will lie t here q uietl y f or a b o ut o ne h o ur, d uri n g w hic h ti me y o u will hear a l o u d mac hi ne- li ke n oise. T he M RI sca n is d o ne i n t he Ra di ol o g y De part me nt a n d ta kes a p pr o xi matel y a n h o ur a n d a half t o c o m plete.  
B o ne sc a n: A b o ne sca n is a test t hat ma kes detaile d i ma ges of y o ur b o nes a n d a n y t u m ors o n t he m. Bef ore t he b o ne sca n, a s mall a m o u nt of ra di oacti ve s u bsta nce is i njecte d i nt o y o ur vei n. A b o ut 3 h o urs later, y o u will lie o n a ta ble u n der a mac hi ne, w hic h will ma ke a n i ma ge of y o ur b o nes. T he test itself will ta ke a b o ut 1 h o ur, b ut t he w h ole pr ocess ta kes u p t o 4 h o urs.  
Electr oc ar di o gr a m ( E C G): rec or ds t he electrical acti vit y of y o ur heart. Wires or "lea ds" will be attac he d t o y o ur c hest wit h a n a d hesi ve a n d y o u will be as ke d t o lie still w hile t he mac hi ne pri nts o ut a n electrical "rec or d" of y o ur heart acti vit y. T he pr oce d ure is d o ne i n t he Car di ol o g y De part me nt a n d ta kes a b o ut 1 5- 3 0 mi n utes.  
Y o u will be as ke d a b o ut a n y me dici nes y o u are ta ki n g i ncl u di n g o ver-t he-c o u nter me dici nes, vita mi ns, or her bal treat me nts.  
Perf or m a nce st at us t o assess h o w y o ur disease is affecti n g y o ur dail y acti vities.  
Eit her a M U G A ( m ulti ple- gate d ac q uisiti o n) sca n or a n E C H O (ec h ocar di o gra m), n o ni n vasi ve tests w hic h ta ke m o vi n g pict ures of y o ur heart will als o be d o ne. T hese will be d o ne wit hi n 4 2 of re gistrati o n.  
M U G A sc a n : A M U G A sca n is a test t hat ma kes a m oti o n pict ure t hat s h o ws h o w well y o ur heart p u m ps bl o o d. T he sca n is perf or me d b y ta ki n g a s mall sa m ple of y o ur o w n bl o o d t hat is t he n "la bele d" wit h a ra di oacti ve s u bsta nce. T he la bele d  
  
bl o o d sa m ple is t he n re-i njecte d i nt o a vei n i n y o ur ar m a n d all o we d t o circ ulate i n y o ur b o d y. O nce t he la bele d bl o o d has circ ulate d ar o u n d y o ur b o d y, a series of i ma ges (si milar t o a m o vie) are ta ke n of y o ur heart. Y o u will be as ke d t o lie flat o n a ta ble a n d re mai n still f or a b o ut 1 0- 2 0 mi n utes w hile t he pict ures of y o ur heart are bei n g ta ke n. T his test is d o ne i n t he N uclear Me dici ne de part me nt a n d ta kes a b o ut 9 0 mi n utes.  
E C H O : T his e xa mi nati o n uses s o u n d wa ves t o ma ke pict ures of y o ur heart, w hic h hel ps deter mi ne h o w well y o ur heart s q ueezes bl o o d. Y o u will be as ke d t o lie o n y o ur left si de w hile a tec h nicia n places a pr o be wit h gel o n y o ur c hest t o create i ma ges of y o ur heart t o deter mi ne t he f u ncti o n a n d size. T he pr oce d ure is d o ne i n t he Car di ol o g y De part me nt a n d will ta ke a p pr o xi matel y 4 5- 6 0 mi n utes.

If t he e xa ms, tests, a n d pr oce d ures s h o w t hat meet t he criteria t o be i n t he researc h st u d y a n d y o u c h o ose t o ta ke part, y o u will t he n be e nr olle d i n t he researc h st u d y. Eac h c ycle of treat me nt will last 2 1 da ys.

If t he e xa ms, tests, a n d pr oce d ures s h o w t hat meet t he criteria t o be i n t he researc h st u d y a n d y o u c h o ose t o ta ke part, y o u will t he n be e nr olle d i n t he researc h st u d y. Eac h c ycle of treat me nt will last 2 1 da ys.

P h ysical E xa mi nati o n Vital si g ns ( bl o o d press ure, heart rate, te m perat ure), hei g ht, a n d wei g ht Bl o o d sa m ples ( ~ 2 ta bles p o o ns of bl o o d):  
Bl o o d c o u nts R o uti ne tests f or safet y P S A  
A d mi nistrati o n of d oceta xel t hr o u g h o ne of y o ur vei ns Start ta ki n g oral pre d nis o ne t wice dail y Re vie w of si de effects Perf or ma nce stat us C o nc urre nt me dicati o ns First oral d ose of ri b ocicli b Bl o o d sa m ples ( ~ 1 ta bles p o o n of bl o o d):  
P har mac o ki netics - T hese are bl o o d tests t hat will hel p deter mi ne t he le vels of st u d y dr u g i n y o ur bl o o d at differe nt ti me p oi nts.

P h ysical E xa mi nati o n Vital si g ns ( bl o o d press ure, heart rate, te m perat ure), hei g ht, a n d wei g ht Bl o o d sa m ples ( ~ 2 ta bles p o o ns of bl o o d):  
Bl o o d c o u nts R o uti ne tests f or safet y P S A  
A d mi nistrati o n of d oceta xel t hr o u g h o ne of y o ur vei ns Start ta ki n g oral pre d nis o ne t wice dail y Re vie w of si de effects Perf or ma nce stat us C o nc urre nt me dicati o ns First oral d ose of ri b ocicli b Bl o o d sa m ples ( ~ 1 ta bles p o o n of bl o o d):  
P har mac o ki netics - T hese are bl o o d tests t hat will hel p deter mi ne t he le vels of st u d y dr u g i n y o ur bl o o d at differe nt ti me p oi nts.

Vital si g ns ( bl o o d press ure, heart rate, te m perat ure)  
Re vie w of si de effects P a g e 5 of 2 5 C C \# 1 4 5 5 1 5  
  
```
Perf or ma nce stat us

Bl o o d sa m ples ( ~ 1 ta bles p o o n of bl o o d):

P har mac o ki netics - T hese are bl o o d tests t hat will hel p deter mi ne t he le vels of

st u d y dr u g i n y o ur bl o o d at differe nt ti me p oi nts.


```

Vital si g ns ( bl o o d press ure, heart rate, te m perat ure)  
Re vie w of si de effects P a g e 5 of 2 5 C C \# 1 4 5 5 1 5  
```
Perf or ma nce stat us

Bl o o d sa m ples ( ~ 1 ta bles p o o n of bl o o d):

P har mac o ki netics - T hese are bl o o d tests t hat will hel p deter mi ne t he le vels of

st u d y dr u g i n y o ur bl o o d at differe nt ti me p oi nts.




```

Ne u p o ge n a d mi nistrati o n - gi ve n u n der t he s ki n dail y o n Da ys 5- 7. T hese i njecti o ns will be a d mi nistere d eit her at h o me or i n t he cli nic.

Ne u p o ge n a d mi nistrati o n - gi ve n u n der t he s ki n dail y o n Da ys 5- 7. T hese i njecti o ns will be a d mi nistere d eit her at h o me or i n t he cli nic.

P h ysical E xa mi nati o n Vital si g ns ( bl o o d press ure, heart rate, te m perat ure)  
Bl o o d sa m ples ( ~ 2 ta bles p o o ns of bl o o d):  
Bl o o d c o u nts R o uti ne tests f or safet y Re vie w of si de effects Perf or ma nce stat us C o nc urre nt me dicati o ns

P h ysical E xa mi nati o n Vital si g ns ( bl o o d press ure, heart rate, te m perat ure)  
Bl o o d sa m ples ( ~ 2 ta bles p o o ns of bl o o d):  
Bl o o d c o u nts R o uti ne tests f or safet y Re vie w of si de effects Perf or ma nce stat us C o nc urre nt me dicati o ns

P h ysical E xa mi nati o n Vital si g ns ( bl o o d press ure, heart rate, te m perat ure), hei g ht, a n d wei g ht Electr ocar di o gra m ( E C G)  
Bl o o d sa m ples ( ~ 2 ta bles p o o ns of bl o o d):  
Bl o o d c o u nts P a g e 6 of 2 5 C C \# 1 4 5 5 1 5 P h ysical E xa mi nati o n Vital si g ns ( bl o o d press ure, heart rate, te m perat ure)  
Electr ocar di o gra m ( E C G)  
Bl o o d sa m ples ( ~ 1 ta bles p o o n of bl o o d):  
Bl o o d c o u nts Re vie w of si de effects Perf or ma nce stat us C o nc urre nt me dicati o ns  
  
R o uti ne tests f or safet y P S A  
A d mi nistrati o n of d oceta xel t hr o u g h o ne of y o ur vei ns Re vie w of si de effects Perf or ma nce stat us C o nc urre nt me dicati o ns

P h ysical E xa mi nati o n Vital si g ns ( bl o o d press ure, heart rate, te m perat ure), hei g ht, a n d wei g ht Electr ocar di o gra m ( E C G)  
Bl o o d sa m ples ( ~ 2 ta bles p o o ns of bl o o d):  
Bl o o d c o u nts P a g e 6 of 2 5 C C \# 1 4 5 5 1 5 P h ysical E xa mi nati o n Vital si g ns ( bl o o d press ure, heart rate, te m perat ure)  
Electr ocar di o gra m ( E C G)  
Bl o o d sa m ples ( ~ 1 ta bles p o o n of bl o o d):  
Bl o o d c o u nts Re vie w of si de effects Perf or ma nce stat us C o nc urre nt me dicati o ns R o uti ne tests f or safet y  
  
P S A  
A d mi nistrati o n of d oceta xel t hr o u g h o ne of y o ur vei ns Re vie w of si de effects Perf or ma nce stat us C o nc urre nt me dicati o ns

Ne u p o ge n a d mi nistrati o n - gi ve n u n der t he s ki n dail y o n Da ys 5- 7. T hese i njecti o ns will be a d mi nistere d eit her at h o me or i n t he cli nic.

Ne u p o ge n a d mi nistrati o n - gi ve n u n der t he s ki n dail y o n Da ys 5- 7. T hese i njecti o ns will be a d mi nistere d eit her at h o me or i n t he cli nic.

P h ysical E xa mi nati o n Vital si g ns ( bl o o d press ure, heart rate, te m perat ure), hei g ht, a n d wei g ht Bl o o d sa m ples ( ~ 2 ta bles p o o ns of bl o o d):  
Bl o o d c o u nts R o uti ne tests f or safet y P S A  
A d mi nistrati o n of d oceta xel t hr o u g h o ne of y o ur vei ns Re vie w of si de effects Electr ocar di o gra m ( E C G)  
Perf or ma nce stat us C o nc urre nt me dicati o ns

P h ysical E xa mi nati o n Vital si g ns ( bl o o d press ure, heart rate, te m perat ure), hei g ht, a n d wei g ht Bl o o d sa m ples ( ~ 2 ta bles p o o ns of bl o o d):  
Bl o o d c o u nts R o uti ne tests f or safet y P S A  
A d mi nistrati o n of d oceta xel t hr o u g h o ne of y o ur vei ns Re vie w of si de effects Electr ocar di o gra m ( E C G)  
Perf or ma nce stat us C o nc urre nt me dicati o ns

Ne u p o ge n a d mi nistrati o n - gi ve n u n der t he s ki n dail y o n Da ys 5- 7. T hese i njecti o ns will  
be a d mi nistere d eit her at h o me or i n t he cli nic.

Ne u p o ge n a d mi nistrati o n - gi ve n u n der t he s ki n dail y o n Da ys 5- 7. T hese i njecti o ns will  
be a d mi nistere d eit her at h o me or i n t he cli nic.

D uri n g t his visit, y o u will ha ve t he f oll o wi n g e xa ms, tests, or pr oce d ures at t he ti me, as s pecifie d. T he visit will be d o ne wit hi n 3 0 da ys of t he last treat me nt.  
P h ysical E xa mi nati o n Vital si g ns ( bl o o d press ure, heart rate, te m perat ure), hei g ht, a n d wei g ht Bl o o d sa m ples ( ~ 2 ta bles p o o ns of bl o o d):  
Bl o o d c o u nts R o uti ne tests f or safet y P S A  
Re vie w of si de effects Perf or ma nce stat us C o nc urre nt me dicati o ns C T or M RI of t he c hest/a b d o me n/ pel vis (if n ot alrea d y c o m plete d wit hi n past 2 8 da ys)  
B o ne sca n (if n ot alrea d y c o m plete d wit hi n past 2 8 da ys)  
Y o u will be c o nt acte d 3 0 d a ys after t he l ast d ose of st u d y tre at me nt . Y o u will be as ke d h o w y o u are feeli n g a n d w hat me dicati o ns y o u ha ve bee n ta ki n g.  
If y o u wit h dr a w fr o m t he st u d y, a n d y o ur disease has n ot pr o gresse d, y o u ma y be c o ntacte d via a p h o ne call, a n d as ke d t o ha ve a C T/ M RI sca n d o ne e ver y t w o m o nt hs t o meas ure y o ur disease si nce st o p pi n g st u d y treat me nt. T his will be d o ne f or researc h p ur p oses if t his sca n is d o ne at a ti me p oi nt ot her t ha n y o ur r o uti ne resta gi n g ti me p oi nt.

D uri n g t his visit, y o u will ha ve t he f oll o wi n g e xa ms, tests, or pr oce d ures at t he ti me, as s pecifie d. T he visit will be d o ne wit hi n 3 0 da ys of t he last treat me nt.  
P h ysical E xa mi nati o n  
  
Vital si g ns ( bl o o d press ure, heart rate, te m perat ure), hei g ht, a n d wei g ht Bl o o d sa m ples ( ~ 2 ta bles p o o ns of bl o o d):  
Bl o o d c o u nts R o uti ne tests f or safet y P S A  
Re vie w of si de effects Perf or ma nce stat us C o nc urre nt me dicati o ns C T or M RI of t he c hest/a b d o me n/ pel vis (if n ot alrea d y c o m plete d wit hi n past 2 8 da ys)  
B o ne sca n (if n ot alrea d y c o m plete d wit hi n past 2 8 da ys)  
Y o u will be c o nt acte d 3 0 d a ys after t he l ast d ose of st u d y tre at me nt . Y o u will be as ke d h o w y o u are feeli n g a n d w hat me dicati o ns y o u ha ve bee n ta ki n g.  
If y o u wit h dr a w fr o m t he st u d y, a n d y o ur disease has n ot pr o gresse d, y o u ma y be c o ntacte d via a p h o ne call, a n d as ke d t o ha ve a C T/ M RI sca n d o ne e ver y t w o m o nt hs t o meas ure y o ur disease si nce st o p pi n g st u d y treat me nt. T his will be d o ne f or researc h p ur p oses if t his sca n is d o ne at a ti me p oi nt ot her t ha n y o ur r o uti ne resta gi n g ti me p oi nt.

Y o u will c o nti n ue st u d y treat me nt u ntil y o u e x perie nce disease pr o gressi o n, disc o nti n ue treat me nt d ue t o i nt olera ble t o xicit y, i n vesti gat or decisi o n, or wit h dra w c o nse nt, w hic he ver occ urs first. Y o u will be treate d wit h t he c o m bi nati o n of ri b ocicli b pl us d oceta xel + pre d nis o ne f or u p t o 9 c ycles. If t here is n o e vi de nce of disease pr o gressi o n after 9 c ycles of pr ot oc ol t hera p y, patie nts ma y c o nti n ue o n si n gle a ge nt mai nte na nce ri b ocicli b u ntil t he ti me of disease pr o gressi o n.  
Y o ur d oct or ca n als o deci de t o wit h dra w y o u fr o m t he st u d y if he/s he feels t hat t his is best f or y o u.

Y o u will c o nti n ue st u d y treat me nt u ntil y o u e x perie nce disease pr o gressi o n, disc o nti n ue treat me nt d ue t o i nt olera ble t o xicit y, i n vesti gat or decisi o n, or wit h dra w c o nse nt, w hic he ver occ urs first. Y o u will be treate d wit h t he c o m bi nati o n of ri b ocicli b pl us d oceta xel + pre d nis o ne f or u p t o 9 c ycles. If t here is n o e vi de nce of disease pr o gressi o n after 9 c ycles of pr ot oc ol t hera p y, patie nts ma y c o nti n ue o n si n gle a ge nt mai nte na nce ri b ocicli b u ntil t he ti me of disease pr o gressi o n.  
Y o ur d oct or ca n als o deci de t o wit h dra w y o u fr o m t he st u d y if he/s he feels t hat t his is best f or y o u.
Clinical trial: NCT02494921
Section: Participant Responsibilities
Subsections: W H At Will I Be As Ke D T O D O W Hile P Artici P Ati N G I N T He St U D Y ?|W H At Will I Be As Ke D T O D O W Hile P Artici P Ati N G I N T He St U D Y ?|W H At Will I Be As Ke D T O D O W Hile P Artici P Ati N G I N T He St U D Y ?|W H At Will I Be As Ke D T O D O W Hile P Artici P Ati N G I N T He St U D Y ?

I n or der f or t his st u d y t o pr o vi de g o o d i nf or mati o n a b o ut h o w t he dr u gs w or k, y o u will be as ke d t o d o t he f oll o wi n g:  
C o m pl y wit h y o ur st u d y d oct or's i nstr ucti o ns. Please n ote: It is ver y i m p orta nt t hat y o u ta ke t he me dici ne gi ve n t o y o u j ust as t he d oct or tells y o u t o. D o n ot miss a n y d oses a n d d o n ot tr y t o d o u ble t he d ose if y o u miss a d ose.  
N otif y y o ur st u d y d oct or i m me diatel y of a n y i nj ur y or u n us ual s y m pt o ms d uri n g y o ur partici pati o n i n t his st u d y.  
Re vie w all t he healt h f o o d s u p ple me nts, o ver-t he-c o u nter a n d prescri pti o n me dicati o ns wit h y o ur st u d y d oct or bef ore ta ki n g t he m.  
Wit h t he e xce pti o n of e mer ge ncies, y o u s h o ul d n ot ta ke ot her dr u gs w hile y o u are partici pati n g i n t he st u d y wit h o ut ha vi n g c o ns ulte d y o ur st u d y d oct or. I n case of a n e mer ge nc y treat me nt, y o ur st u d y d oct or s h o ul d be i nf or me d i m me diatel y.  
Bri n g all of y o ur e xtra st u d y dr u g me dicati o n a n d e m pt y pill b ottles bac k t o t he st u d y d oct or.  
D o n ot eat or dri n k gra pefr uit, Se ville (s o ur/ bl o o d) ora n ges or pr o d ucts c o ntai ni n g t he j uice of eac h d uri n g t he st u d y, as t hese fr uits a n d t heir j uice ca n i nterfere wit h t he bl o o d le vels of t he dr u gs. Re g ular ora n ge j uice is o ka y.  
O n t he da ys t hat y o u c o me t o cli nic visits, y o u will ta ke t he st u d y dr u g t here. After war d, y o u will be pr o vi de d wit h e n o u g h st u d y me dicati o n u ntil y o ur ne xt pla n ne d cli nic visit.  
Y o u will be as ke d t o rec or d t he date a n d ti me y o u t o o k t he st u d y me dicati o n a n d a n y si de effects y o u ma y e x perie nce i n a diar y. T his diar y m ust be ret ur ne d t o y o ur st u d y d oct or at y o ur ne xt visit.  
D uri n g t he w h ole d urati o n of treat me nt o n t his st u d y, y o u are n ot all o we d t o partici pate i n a n ot her cli nical st u d y t hat ma y i nterfere wit h t his st u d y. If y o u are i ntereste d i n partici pati n g i n a n ot her st u d y, y o u m ust s pea k t o y o ur st u d y d oct or a b o ut it.

I n or der f or t his st u d y t o pr o vi de g o o d i nf or mati o n a b o ut h o w t he dr u gs w or k, y o u will be as ke d t o d o t he f oll o wi n g:  
C o m pl y wit h y o ur st u d y d oct or's i nstr ucti o ns. Please n ote: It is ver y i m p orta nt t hat y o u  
  
ta ke t he me dici ne gi ve n t o y o u j ust as t he d oct or tells y o u t o. D o n ot miss a n y d oses a n d d o n ot tr y t o d o u ble t he d ose if y o u miss a d ose.  
N otif y y o ur st u d y d oct or i m me diatel y of a n y i nj ur y or u n us ual s y m pt o ms d uri n g y o ur partici pati o n i n t his st u d y.  
Re vie w all t he healt h f o o d s u p ple me nts, o ver-t he-c o u nter a n d prescri pti o n me dicati o ns wit h y o ur st u d y d oct or bef ore ta ki n g t he m.  
Wit h t he e xce pti o n of e mer ge ncies, y o u s h o ul d n ot ta ke ot her dr u gs w hile y o u are partici pati n g i n t he st u d y wit h o ut ha vi n g c o ns ulte d y o ur st u d y d oct or. I n case of a n e mer ge nc y treat me nt, y o ur st u d y d oct or s h o ul d be i nf or me d i m me diatel y.  
Bri n g all of y o ur e xtra st u d y dr u g me dicati o n a n d e m pt y pill b ottles bac k t o t he st u d y d oct or.  
D o n ot eat or dri n k gra pefr uit, Se ville (s o ur/ bl o o d) ora n ges or pr o d ucts c o ntai ni n g t he j uice of eac h d uri n g t he st u d y, as t hese fr uits a n d t heir j uice ca n i nterfere wit h t he bl o o d le vels of t he dr u gs. Re g ular ora n ge j uice is o ka y.  
O n t he da ys t hat y o u c o me t o cli nic visits, y o u will ta ke t he st u d y dr u g t here. After war d, y o u will be pr o vi de d wit h e n o u g h st u d y me dicati o n u ntil y o ur ne xt pla n ne d cli nic visit.  
Y o u will be as ke d t o rec or d t he date a n d ti me y o u t o o k t he st u d y me dicati o n a n d a n y si de effects y o u ma y e x perie nce i n a diar y. T his diar y m ust be ret ur ne d t o y o ur st u d y d oct or at y o ur ne xt visit.  
D uri n g t he w h ole d urati o n of treat me nt o n t his st u d y, y o u are n ot all o we d t o partici pate i n a n ot her cli nical st u d y t hat ma y i nterfere wit h t his st u d y. If y o u are i ntereste d i n partici pati n g i n a n ot her st u d y, y o u m ust s pea k t o y o ur st u d y d oct or a b o ut it.

I n or der f or t his st u d y t o pr o vi de g o o d i nf or mati o n a b o ut h o w t he dr u gs w or k, y o u will be as ke d t o d o t he f oll o wi n g:  
C o m pl y wit h y o ur st u d y d oct or's i nstr ucti o ns. Please n ote: It is ver y i m p orta nt t hat y o u ta ke t he me dici ne gi ve n t o y o u j ust as t he d oct or tells y o u t o. D o n ot miss a n y d oses a n d d o n ot tr y t o d o u ble t he d ose if y o u miss a d ose.  
N otif y y o ur st u d y d oct or i m me diatel y of a n y i nj ur y or u n us ual s y m pt o ms d uri n g y o ur partici pati o n i n t his st u d y.  
Re vie w all t he healt h f o o d s u p ple me nts, o ver-t he-c o u nter a n d prescri pti o n me dicati o ns wit h y o ur st u d y d oct or bef ore ta ki n g t he m.  
Wit h t he e xce pti o n of e mer ge ncies, y o u s h o ul d n ot ta ke ot her dr u gs w hile y o u are partici pati n g i n t he st u d y wit h o ut ha vi n g c o ns ulte d y o ur st u d y d oct or. I n case of a n e mer ge nc y treat me nt, y o ur st u d y d oct or s h o ul d be i nf or me d i m me diatel y.  
Bri n g all of y o ur e xtra st u d y dr u g me dicati o n a n d e m pt y pill b ottles bac k t o t he st u d y d oct or.  
D o n ot eat or dri n k gra pefr uit, Se ville (s o ur/ bl o o d) ora n ges or pr o d ucts c o ntai ni n g t he j uice of eac h d uri n g t he st u d y, as t hese fr uits a n d t heir j uice ca n i nterfere wit h t he bl o o d le vels of t he dr u gs. Re g ular ora n ge j uice is o ka y.  
O n t he da ys t hat y o u c o me t o cli nic visits, y o u will ta ke t he st u d y dr u g t here. After war d, y o u will be pr o vi de d wit h e n o u g h st u d y me dicati o n u ntil y o ur ne xt pla n ne d cli nic visit.  
Y o u will be as ke d t o rec or d t he date a n d ti me y o u t o o k t he st u d y me dicati o n a n d a n y si de effects y o u ma y e x perie nce i n a diar y. T his diar y m ust be ret ur ne d t o y o ur st u d y d oct or at y o ur ne xt visit.  
D uri n g t he w h ole d urati o n of treat me nt o n t his st u d y, y o u are n ot all o we d t o partici pate i n a n ot her cli nical st u d y t hat ma y i nterfere wit h t his st u d y. If y o u are i ntereste d i n partici pati n g i n a n ot her st u d y, y o u m ust s pea k t o y o ur st u d y d oct or a b o ut it.

I n or der f or t his st u d y t o pr o vi de g o o d i nf or mati o n a b o ut h o w t he dr u gs w or k, y o u will be as ke d t o d o t he f oll o wi n g:  
C o m pl y wit h y o ur st u d y d oct or's i nstr ucti o ns. Please n ote: It is ver y i m p orta nt t hat y o u  
  
ta ke t he me dici ne gi ve n t o y o u j ust as t he d oct or tells y o u t o. D o n ot miss a n y d oses a n d d o n ot tr y t o d o u ble t he d ose if y o u miss a d ose.  
N otif y y o ur st u d y d oct or i m me diatel y of a n y i nj ur y or u n us ual s y m pt o ms d uri n g y o ur partici pati o n i n t his st u d y.  
Re vie w all t he healt h f o o d s u p ple me nts, o ver-t he-c o u nter a n d prescri pti o n me dicati o ns wit h y o ur st u d y d oct or bef ore ta ki n g t he m.  
Wit h t he e xce pti o n of e mer ge ncies, y o u s h o ul d n ot ta ke ot her dr u gs w hile y o u are partici pati n g i n t he st u d y wit h o ut ha vi n g c o ns ulte d y o ur st u d y d oct or. I n case of a n e mer ge nc y treat me nt, y o ur st u d y d oct or s h o ul d be i nf or me d i m me diatel y.  
Bri n g all of y o ur e xtra st u d y dr u g me dicati o n a n d e m pt y pill b ottles bac k t o t he st u d y d oct or.  
D o n ot eat or dri n k gra pefr uit, Se ville (s o ur/ bl o o d) ora n ges or pr o d ucts c o ntai ni n g t he j uice of eac h d uri n g t he st u d y, as t hese fr uits a n d t heir j uice ca n i nterfere wit h t he bl o o d le vels of t he dr u gs. Re g ular ora n ge j uice is o ka y.  
O n t he da ys t hat y o u c o me t o cli nic visits, y o u will ta ke t he st u d y dr u g t here. After war d, y o u will be pr o vi de d wit h e n o u g h st u d y me dicati o n u ntil y o ur ne xt pla n ne d cli nic visit.  
Y o u will be as ke d t o rec or d t he date a n d ti me y o u t o o k t he st u d y me dicati o n a n d a n y si de effects y o u ma y e x perie nce i n a diar y. T his diar y m ust be ret ur ne d t o y o ur st u d y d oct or at y o ur ne xt visit.  
D uri n g t he w h ole d urati o n of treat me nt o n t his st u d y, y o u are n ot all o we d t o partici pate i n a n ot her cli nical st u d y t hat ma y i nterfere wit h t his st u d y. If y o u are i ntereste d i n partici pati n g i n a n ot her st u d y, y o u m ust s pea k t o y o ur st u d y d oct or a b o ut it.
Clinical trial: NCT02494921
Section: Participant's Rights
Subsections: W H At Are M Y Ri G Hts If I T A Ke P Art I N T His St U D Y ?|W H At Are M Y Ri G Hts If I T A Ke P Art I N T His St U D Y ?|W H At Are M Y Ri G Hts If I T A Ke P Art I N T His St U D Y ?|W H At Are M Y Ri G Hts If I T A Ke P Art I N T His St U D Y ?

Ta ki n g part i n t his st u d y is y o ur c h oice. Y o u ma y c h o ose eit her t o ta ke part or n ot t o ta ke part i n t he st u d y. If y o u deci de t o ta ke part i n t his st u d y, y o u ma y lea ve t he st u d y at a n y ti me. N o matter w hat decisi o n y o u ma ke, t here will be n o pe nalt y t o y o u a n d y o u will n ot l ose a n y of y o ur re g ular be nefits. Lea vi n g t he st u d y will n ot affect y o ur me dical care. Y o u ca n still get y o ur me dical care fr o m o ur i nstit uti o n.  
P a g e 1 8 of 2 5 C C \# 1 4 5 5 1 5  
  
We will tell y o u a b o ut ne w i nf or mati o n or c ha n ges i n t he st u d y t hat ma y affect y o ur healt h or y o ur willi n g ness t o c o nti n ue i n t he st u d y.  
I n t he case of i nj ur y res ulti n g fr o m t his st u d y, y o u d o n ot l ose a n y of y o ur le gal ri g hts t o see k pa y me nt b y si g ni n g t his f or m.

Ta ki n g part i n t his st u d y is y o ur c h oice. Y o u ma y c h o ose eit her t o ta ke part or n ot t o ta ke part i n t he st u d y. If y o u deci de t o ta ke part i n t his st u d y, y o u ma y lea ve t he st u d y at a n y ti me. N o matter w hat decisi o n y o u ma ke, t here will be n o pe nalt y t o y o u a n d y o u will n ot l ose a n y of y o ur re g ular be nefits. Lea vi n g t he st u d y will n ot affect y o ur me dical care. Y o u ca n still get y o ur me dical care fr o m o ur i nstit uti o n.  
P a g e 1 8 of 2 5 C C \# 1 4 5 5 1 5  
We will tell y o u a b o ut ne w i nf or mati o n or c ha n ges i n t he st u d y t hat ma y affect y o ur healt h or  
  
y o ur willi n g ness t o c o nti n ue i n t he st u d y.  
I n t he case of i nj ur y res ulti n g fr o m t his st u d y, y o u d o n ot l ose a n y of y o ur le gal ri g hts t o see k pa y me nt b y si g ni n g t his f or m.

Ta ki n g part i n t his st u d y is y o ur c h oice. Y o u ma y c h o ose eit her t o ta ke part or n ot t o ta ke part i n t he st u d y. If y o u deci de t o ta ke part i n t his st u d y, y o u ma y lea ve t he st u d y at a n y ti me. N o matter w hat decisi o n y o u ma ke, t here will be n o pe nalt y t o y o u a n d y o u will n ot l ose a n y of y o ur re g ular be nefits. Lea vi n g t he st u d y will n ot affect y o ur me dical care. Y o u ca n still get y o ur me dical care fr o m o ur i nstit uti o n.  
P a g e 1 8 of 2 5 C C \# 1 4 5 5 1 5  
  
We will tell y o u a b o ut ne w i nf or mati o n or c ha n ges i n t he st u d y t hat ma y affect y o ur healt h or y o ur willi n g ness t o c o nti n ue i n t he st u d y.  
I n t he case of i nj ur y res ulti n g fr o m t his st u d y, y o u d o n ot l ose a n y of y o ur le gal ri g hts t o see k pa y me nt b y si g ni n g t his f or m.

Ta ki n g part i n t his st u d y is y o ur c h oice. Y o u ma y c h o ose eit her t o ta ke part or n ot t o ta ke part i n t he st u d y. If y o u deci de t o ta ke part i n t his st u d y, y o u ma y lea ve t he st u d y at a n y ti me. N o matter w hat decisi o n y o u ma ke, t here will be n o pe nalt y t o y o u a n d y o u will n ot l ose a n y of y o ur re g ular be nefits. Lea vi n g t he st u d y will n ot affect y o ur me dical care. Y o u ca n still get y o ur me dical care fr o m o ur i nstit uti o n.  
P a g e 1 8 of 2 5 C C \# 1 4 5 5 1 5  
We will tell y o u a b o ut ne w i nf or mati o n or c ha n ges i n t he st u d y t hat ma y affect y o ur healt h or  
  
y o ur willi n g ness t o c o nti n ue i n t he st u d y.  
I n t he case of i nj ur y res ulti n g fr o m t his st u d y, y o u d o n ot l ose a n y of y o ur le gal ri g hts t o see k pa y me nt b y si g ni n g t his f or m.
Clinical trial: NCT02494921
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: W H At Si De Effects Or Ris Ks C A N I E X Pect Fr O M Bei N G I N T He St U D Y ?|W H At Si De Effects Or Ris Ks C A N I E X Pect Fr O M Bei N G I N T He St U D Y ?|Ris Ks Rel Ate D T O Ri B Ocicli B|Ris Ks Rel Ate D T O Ri B Ocicli B|Li Kel Y|Li Kel Y|Ris Ks Rel Ate D T O Ne U P O Ge N ( G- C S F):|Ris Ks Rel Ate D T O Ne U P O Ge N ( G- C S F):|Ot Her Ris Ks Rel Ate D T O T His St U D Y I Ncl U De:|Ot Her Ris Ks Rel Ate D T O T His St U D Y I Ncl U De:|Are T Here Be Nefits T O T A Ki N G P Art I N T He St U D Y ?|Are T Here Be Nefits T O T A Ki N G P Art I N T He St U D Y ?|Will I Be P Ai D F Or T A Ki N G P Art I N T His St U D Y ? Y O U Will N Ot Be Pai D F Or Ta Ki N G Part I N T His St U D Y. W H At H A P Pe Ns If I A M I Nj Ure D Bec A Use I T O O K P Art I N T His St U D Y ?|Will I Be P Ai D F Or T A Ki N G P Art I N T His St U D Y ? Y O U Will N Ot Be Pai D F Or Ta Ki N G Part I N T His St U D Y. W H At H A P Pe Ns If I A M I Nj Ure D Bec A Use I T O O K P Art I N T His St U D Y ?|Be Nefits|Be Nefits|O Ver All Ris K|O Ver All Ris K|W H At Si De Effects Or Ris Ks C A N I E X Pect Fr O M Bei N G I N T He St U D Y ?|W H At Si De Effects Or Ris Ks C A N I E X Pect Fr O M Bei N G I N T He St U D Y ?|Ris Ks Rel Ate D T O Ri B Ocicli B|Ris Ks Rel Ate D T O Ri B Ocicli B|Li Kel Y|Li Kel Y|Ris Ks Rel Ate D T O Ne U P O Ge N ( G- C S F):|Ris Ks Rel Ate D T O Ne U P O Ge N ( G- C S F):|Ot Her Ris Ks Rel Ate D T O T His St U D Y I Ncl U De:|Ot Her Ris Ks Rel Ate D T O T His St U D Y I Ncl U De:|Are T Here Be Nefits T O T A Ki N G P Art I N T He St U D Y ?|Are T Here Be Nefits T O T A Ki N G P Art I N T He St U D Y ?|Will I Be P Ai D F Or T A Ki N G P Art I N T His St U D Y ? Y O U Will N Ot Be Pai D F Or Ta Ki N G Part I N T His St U D Y. W H At H A P Pe Ns If I A M I Nj Ure D Bec A Use I T O O K P Art I N T His St U D Y ?|Will I Be P Ai D F Or T A Ki N G P Art I N T His St U D Y ? Y O U Will N Ot Be Pai D F Or Ta Ki N G Part I N T His St U D Y. W H At H A P Pe Ns If I A M I Nj Ure D Bec A Use I T O O K P Art I N T His St U D Y ?|Be Nefits|Be Nefits|O Ver All Ris K|O Ver All Ris K

Ris ks are p ossi ble si de effects of st u d y me dici ne, or u n der g oi n g tests, s uc h as i ma gi n g sca ns a n d bl o o d or t u m or sa m ple c ollecti o n.  
T he p ote ntial si de effects descri be d bel o w f or ri b ocicli b are base d o n tests i n a ni mals a n d e x perie nce i n ca ncer s u bjects. It is p ossi ble t hat y o u ma y e x perie nce si de effects t hat are u ne x pecte d a n d u nf oresee n. E ver y o ne ta ki n g part i n t he st u d y will be watc he d caref ull y f or a n y si de effects. Pre ve nti n g si de effects, w he n p ossi ble, is a n i m p orta nt part of all ca ncer care.  
T he p ote ntial si de effects descri be d bel o w f or ri b ocicli b a n d B Y L 7 1 9 are base d o n tests i n a ni mals a n d e x perie nce i n ca ncer patie nts. T he p ote ntial si de effects descri be d bel o w f or letr oz ole are base d o n e xte nsi ve e x perie nce i n ca ncer patie nts. It is p ossi ble t hat y o u ma y e x perie nce si de effects t hat are t otall y u ne x pecte d a n d u nf oresee n. E ver y o ne ta ki n g part i n t he st u d y will be watc he d caref ull y f or a n y si de effects, a n d tr yi n g t o pre ve nt t he m, w he n p ossi ble, is a n i m p orta nt part of all ca ncer care.

Ris ks are p ossi ble si de effects of st u d y me dici ne, or u n der g oi n g tests, s uc h as i ma gi n g sca ns a n d bl o o d or t u m or sa m ple c ollecti o n.  
T he p ote ntial si de effects descri be d bel o w f or ri b ocicli b are base d o n tests i n a ni mals a n d e x perie nce i n ca ncer s u bjects. It is p ossi ble t hat y o u ma y e x perie nce si de effects t hat are u ne x pecte d a n d u nf oresee n. E ver y o ne ta ki n g part i n t he st u d y will be watc he d caref ull y f or a n y si de effects. Pre ve nti n g si de effects, w he n p ossi ble, is a n i m p orta nt part of all ca ncer care.  
T he p ote ntial si de effects descri be d bel o w f or ri b ocicli b a n d B Y L 7 1 9 are base d o n tests i n a ni mals a n d e x perie nce i n ca ncer patie nts. T he p ote ntial si de effects descri be d bel o w f or letr oz ole are base d o n e xte nsi ve e x perie nce i n ca ncer patie nts. It is p ossi ble t hat y o u ma y e x perie nce si de effects t hat are t otall y u ne x pecte d a n d u nf oresee n. E ver y o ne ta ki n g part i n t he st u d y will be watc he d caref ull y f or a n y si de effects, a n d tr yi n g t o pre ve nt t he m, w he n p ossi ble, is a n i m p orta nt part of all ca ncer care.

Ri b ocicli b is a n i n vesti gati o nal dr u g a n d n ot all of t he si de effects are k n o w n. Seri o us si de effects, i ncl u di n g deat h, are a p ossi bilit y. T he l o n g-ter m effects of ri b ocicli b are als o u n k n o w n.  
Ris ks are p ossi ble si de effects of st u d y me dici ne gi ve n al o ne or i n c o m bi nati o n wit h ot her me dicati o n(s), a n d t h ose of ta ki n g bl o o d. Base d o n t he data fr o m o n g oi n g st u dies i n ca ncer patie nts, t he f oll o wi n g are t he p ossi ble ris ks wit h ta ki n g ri b ocicli b.  
Ver y c o m m o n si de effects m ay affect m ore t h a n 1 0 % of pe o ple  
L o w w hite bl o o d cell c o u nt w hic h i ncreases t he ris k of i nfecti o ns ( ne utr o pe nia or le u k o pe nia)  
I nfecti o ns (i ncl u di n g uri nar y tract i nfecti o ns, res pirat or y i nfecti o ns, gastr oe nteritis a n d se vere, p ote ntiall y life-t hreate ni n g i nfecti o ns [se psis; t his is u nc o m m o n])  
L o w re d bl o o d cell c o u nt w hic h ca n lea d t o tire d ness a n d wea k ness (a ne mia)  
  
```
Na usea

Diarr hea

V o miti n g

C o nsti pati o n

M o ut h s ores, or pai n, i nfla m mati o n a n d/ or i nfecti o n of t he m o ut h

A b d o mi nal pai n

Tire d ness or ge neralize d wea k ness (fati g ue or ast he nia)

S welli n g of t he ar ms or le gs ( peri p heral oe de ma)

Fe ver ( p yre xia)

I ncrease i n t he bl o o d le vels of li ver para meters as i n dicate d b y li ver tests (s uc h as

tra nsa mi nases a n d/ or bilir u bi n)

Decrease d a p petite

Bac k pai n

Hea dac he

Dizzi ness

S h ort ness of breat h ( d ys p nea)

C o u g h

Hair t hi n ni n g or l oss (al o pecia)

S ki n ras h

Itc hi n g of t he s ki n ( pr urit us)

C o m m o n si de effects m ay affect u p t o 1 0 % of pe o ple


```  
L o w platelet c o u nt w hic h ca n lea d t o eas y br uisi n g a n d blee di n g (t hr o m b oc yt o pe nia)  
L o w w hite bl o o d cell c o u nt wit h fe ver (fe brile ne utr o pe nia)  
L o w l y m p h oc yte c o u nt i n t he bl o o d t hat ca n pre dis p ose t o i nfecti o ns (l y m p h o pe nia)  
Fai nti n g e pis o des/tra nsie nt l oss of c o nsci o us ness a n d p ost ural p ost ure (s y nc o pe)  
E xcessi ve teari n g of t he e ye (i ncrease d lacri mati o n)  
Dr y e ye Taste alterati o n ( d ys ge usia)  
Dr y m o ut h S ore t hr oat ( or o p har y n geal pai n)  
I n di gesti o n heart b ur n ( d ys pe psia)  
Li ver t o xicit y ( he pat ot o xicit y: i nj ur y of t he li ver d ue t o li ver cell da ma ge, i ncl u di n g li ver fail ure [t he latter is u nc o m m o n])  
I ncrease i n creati ni ne (a waste pr o d uct i n t he bl o o d) a n d a decrease i n t he ki d ne y's a bilit y t o ha n dle t he b o d y's waste ( bl o o d creati ni ne i ncrease d)  
C ha n ges i n t he electrical acti vit y of t he heart calle d Q Tc pr ol o n gati o n. T his is a n a b n or malit y of t he heart r h yt h m a n d ma y ca use dizzi ness, pal pitati o ns, fai nti n g, a n d i n se vere cases l oss of c o nsci o us ness a n d e ve n deat h Decrease d bl o o d calci u m le vels ( h y p ocalcae mia)  
Decrease d bl o o d p otassi u m le vels ( h y p o kale mia)  
P a g e 1 1 of 2 5 C C \# 1 4 5 5 1 5  
  
```
Decrease d bl o o d p h os p h or us le vels ( h y p o p h os p hate mia)

Re d ness of t he s ki n or re d de ni n g of t he s ki n (er yt he ma)

Dr y s ki n

L oss of s ki n c ol orati o n/ w hite ni n g, us uall y i n patc hes ( vitili g o)

Se nsati o n of l osi n g bala nce ( verti g o)

Rare b ut I m p orta nt ( m ay affect less t h a n 5 % of pe o ple ):


```  
P ote ntial acc u m ulati o n of ri b ocicli b i n t he t h yr oi d gla n d. I n rats, ri b ocicli b was f o u n d t o acc u m ulate i n t he t h yr oi d gla n d, b ut t here was n o e vi de nce of da ma ge t o t he t h yr oi d gla n d. T here ha ve bee n n o re p orts of a b n or mal t h yr oi d f u ncti o n i n a n y patie nt s o far.  
O ne patie nt partici pati n g i n a trial wit h ri b ocicli b a n d M E K 1 6 2 die d fr o m blee di n g i n t he brai n, w hic h was c o nsi dere d relate d t o ri b ocicli b a n d M E K 1 6 2 b y t he treati n g p h ysicia n.  
O ne patie nt partici pati n g i n a trial was dia g n ose d wit h ac ute l y m p h o blastic le u ke mia  
( A L L), w hic h t he treati n g p h ysicia n c o nsi dere d p ossi bl y relate d t o ri b ocicli b.  
O ne patie nt partici pati n g i n a trial was dia g n ose d wit h ac ute res pirat or y fail ure, w hic h was c o nsi dere d p ossi bl y relate d t o ri b ocicli b F o ur partici pa nt deat hs occ urre d o n a breast ca ncer st u d y, w hic h were c o nsi dere d t o be relate d t o ri b ocicli b. T w o deat hs were d ue t o ac ute res pirat or y fail ure, a n d t he ot her ca uses of deat h were p ne u m o nia a n d s u d de n deat h.  
O ne patie nt partici pati n g i n a trial wit h ri b ocicli b a n d letr oz ole was dia g n ose d wit h m yel o d ys plastic s y n dr o me, w hic h was c o nsi dere d p ossi bl y relate d t o ri b ocicli b.  
M yel o d ys plastic s y n dr o me ha p pe ns w he n t he b o ne marr o w, t he material i nsi de y o ur b o nes w here y o ur bl o o d cells are ma de, n o l o n ger w or ks n or mall y, w hic h ca n lea d t o feeli n g tire d, s h ort of breat h or ha vi n g s mall re d s p ots u n der y o ur s ki n ca use d b y blee di n g or i nfecti o ns.  
O n patie nt partici pati n g i n a trial wit h ri b ocicli b a n d letr oz ole e x perie nce d decrease d s o di u m le vels. Y o u ma y feel tire d, ha ve a hea dac he, feel na usea or v o mit, or ha ve cra m ps.  
O ne patie nt partici pati n g i n a trial wit h ri b ocicli b a n d letr oz ole was dia g n ose d wit h heart fail ure. Y o u mi g ht feel s h ort of breat h, wea k ness, s welli n g i n y o ur le gs, a n kles or feet, or a n irre g ular or ra pi d heart beat.  
Ris ks a n d si de effects relate d t o d ocet a xel a n d pre d nis o ne i ncl u de t h ose liste d bel o w:

Ri b ocicli b is a n i n vesti gati o nal dr u g a n d n ot all of t he si de effects are k n o w n. Seri o us si de effects, i ncl u di n g deat h, are a p ossi bilit y. T he l o n g-ter m effects of ri b ocicli b are als o u n k n o w n.  
Ris ks are p ossi ble si de effects of st u d y me dici ne gi ve n al o ne or i n c o m bi nati o n wit h ot her me dicati o n(s), a n d t h ose of ta ki n g bl o o d. Base d o n t he data fr o m o n g oi n g st u dies i n ca ncer patie nts, t he f oll o wi n g are t he p ossi ble ris ks wit h ta ki n g ri b ocicli b.  
Ver y c o m m o n si de effects m ay affect m ore t h a n 1 0 % of pe o ple  
L o w w hite bl o o d cell c o u nt w hic h i ncreases t he ris k of i nfecti o ns ( ne utr o pe nia or le u k o pe nia)  
I nfecti o ns (i ncl u di n g uri nar y tract i nfecti o ns, res pirat or y i nfecti o ns, gastr oe nteritis a n d se vere, p ote ntiall y life-t hreate ni n g i nfecti o ns [se psis; t his is u nc o m m o n])  
L o w re d bl o o d cell c o u nt w hic h ca n lea d t o tire d ness a n d wea k ness (a ne mia)  
```
Na usea

Diarr hea

V o miti n g

C o nsti pati o n

M o ut h s ores, or pai n, i nfla m mati o n a n d/ or i nfecti o n of t he m o ut h

A b d o mi nal pai n

Tire d ness or ge neralize d wea k ness (fati g ue or ast he nia)

S welli n g of t he ar ms or le gs ( peri p heral oe de ma)

Fe ver ( p yre xia)

I ncrease i n t he bl o o d le vels of li ver para meters as i n dicate d b y li ver tests (s uc h as

tra nsa mi nases a n d/ or bilir u bi n)

Decrease d a p petite

Bac k pai n

Hea dac he

Dizzi ness

S h ort ness of breat h ( d ys p nea)

C o u g h

Hair t hi n ni n g or l oss (al o pecia)

S ki n ras h

Itc hi n g of t he s ki n ( pr urit us)

C o m m o n si de effects m ay affect u p t o 1 0 % of pe o ple




```  
L o w platelet c o u nt w hic h ca n lea d t o eas y br uisi n g a n d blee di n g (t hr o m b oc yt o pe nia)  
L o w w hite bl o o d cell c o u nt wit h fe ver (fe brile ne utr o pe nia)  
L o w l y m p h oc yte c o u nt i n t he bl o o d t hat ca n pre dis p ose t o i nfecti o ns (l y m p h o pe nia)  
Fai nti n g e pis o des/tra nsie nt l oss of c o nsci o us ness a n d p ost ural p ost ure (s y nc o pe)  
E xcessi ve teari n g of t he e ye (i ncrease d lacri mati o n)  
Dr y e ye Taste alterati o n ( d ys ge usia)  
Dr y m o ut h S ore t hr oat ( or o p har y n geal pai n)  
I n di gesti o n heart b ur n ( d ys pe psia)  
Li ver t o xicit y ( he pat ot o xicit y: i nj ur y of t he li ver d ue t o li ver cell da ma ge, i ncl u di n g li ver fail ure [t he latter is u nc o m m o n])  
I ncrease i n creati ni ne (a waste pr o d uct i n t he bl o o d) a n d a decrease i n t he ki d ne y's a bilit y t o ha n dle t he b o d y's waste ( bl o o d creati ni ne i ncrease d)  
C ha n ges i n t he electrical acti vit y of t he heart calle d Q Tc pr ol o n gati o n. T his is a n a b n or malit y of t he heart r h yt h m a n d ma y ca use dizzi ness, pal pitati o ns, fai nti n g, a n d i n se vere cases l oss of c o nsci o us ness a n d e ve n deat h Decrease d bl o o d calci u m le vels ( h y p ocalcae mia)  
Decrease d bl o o d p otassi u m le vels ( h y p o kale mia)
P a g e 1 1 of 2 5 C C \# 1 4 5 5 1 5  
```
Decrease d bl o o d p h os p h or us le vels ( h y p o p h os p hate mia)

Re d ness of t he s ki n or re d de ni n g of t he s ki n (er yt he ma)

Dr y s ki n

L oss of s ki n c ol orati o n/ w hite ni n g, us uall y i n patc hes ( vitili g o)

Se nsati o n of l osi n g bala nce ( verti g o)

Rare b ut I m p orta nt ( m ay affect less t h a n 5 % of pe o ple ):




```  
P ote ntial acc u m ulati o n of ri b ocicli b i n t he t h yr oi d gla n d. I n rats, ri b ocicli b was f o u n d t o acc u m ulate i n t he t h yr oi d gla n d, b ut t here was n o e vi de nce of da ma ge t o t he t h yr oi d gla n d. T here ha ve bee n n o re p orts of a b n or mal t h yr oi d f u ncti o n i n a n y patie nt s o far.  
O ne patie nt partici pati n g i n a trial wit h ri b ocicli b a n d M E K 1 6 2 die d fr o m blee di n g i n t he brai n, w hic h was c o nsi dere d relate d t o ri b ocicli b a n d M E K 1 6 2 b y t he treati n g p h ysicia n.  
O ne patie nt partici pati n g i n a trial was dia g n ose d wit h ac ute l y m p h o blastic le u ke mia  
( A L L), w hic h t he treati n g p h ysicia n c o nsi dere d p ossi bl y relate d t o ri b ocicli b.  
O ne patie nt partici pati n g i n a trial was dia g n ose d wit h ac ute res pirat or y fail ure, w hic h was c o nsi dere d p ossi bl y relate d t o ri b ocicli b F o ur partici pa nt deat hs occ urre d o n a breast ca ncer st u d y, w hic h were c o nsi dere d t o be relate d t o ri b ocicli b. T w o deat hs were d ue t o ac ute res pirat or y fail ure, a n d t he ot her ca uses of deat h were p ne u m o nia a n d s u d de n deat h.  
O ne patie nt partici pati n g i n a trial wit h ri b ocicli b a n d letr oz ole was dia g n ose d wit h m yel o d ys plastic s y n dr o me, w hic h was c o nsi dere d p ossi bl y relate d t o ri b ocicli b.  
M yel o d ys plastic s y n dr o me ha p pe ns w he n t he b o ne marr o w, t he material i nsi de y o ur b o nes w here y o ur bl o o d cells are ma de, n o l o n ger w or ks n or mall y, w hic h ca n lea d t o feeli n g tire d, s h ort of breat h or ha vi n g s mall re d s p ots u n der y o ur s ki n ca use d b y blee di n g or i nfecti o ns.  
O n patie nt partici pati n g i n a trial wit h ri b ocicli b a n d letr oz ole e x perie nce d decrease d s o di u m le vels. Y o u ma y feel tire d, ha ve a hea dac he, feel na usea or v o mit, or ha ve cra m ps.  
O ne patie nt partici pati n g i n a trial wit h ri b ocicli b a n d letr oz ole was dia g n ose d wit h heart fail ure. Y o u mi g ht feel s h ort of breat h, wea k ness, s welli n g i n y o ur le gs, a n kles or feet, or a n irre g ular or ra pi d heart beat.  
Ris ks a n d si de effects relate d t o d ocet a xel a n d pre d nis o ne i ncl u de t h ose liste d bel o w:

Ras h Hair l oss Fl ui d rete nti o n/s welli n g Fati g ue U pset st o mac h S ore ness a n d/ or wea k ness of m uscles a n d/ or j oi nts P a g e 1 2 of 2 5 C C \# 1 4 5 5 1 5  
```
I ncrease d bl o o d s u gar le vels, w hic h ma y ca use i ncrease d t hirst, uri nati o n, a n d fati g ue

L o were d w hite bl o o d cell c o u nt t hat ma y lea d t o i ncrease d ris k of i nfecti o n

L o were d platelet c o u nt t hat ma y lea d t o i ncrease d br uisi n g or blee di n g

L o were d re d bl o o d cell c o u nt t hat ma y ca use tire d ness or s h ort ness of breat h (if t he c o u nt

gets t o o l o w y o u ma y nee d a tra nsf usi o n)

Less Li kel y


Diarr hea

Na usea a n d v o miti n g

M o ut h a n d t hr oat s ores

L oss of a p petite

L oss of refle xes

Dar ke ni n g or li g hte ni n g of fi n ger nail be ds

Peeli n g s ki n o n ha n ds a n d feet

I ns o m nia

N u m b ness a n d/ or ti n gli n g of t he fi n gers a n d t oes

Rare, b ut seri o us


```  
St o mac h ulcers a n d/ or blee di n g  
  
Se vere aller gic reacti o n (life-t hreate ni n g breat hi n g pr o ble ms)  
A b n or mal f u ncti o n of t he a dre nal gla n d w hic h ca n ca use wea k ness a n d fati g ue, l o w bl o o d press ure, na usea, v o miti n g, diarr hea, irrita bilit y a n d/ or restless ness, l oss of b o ne de nsit y L o w bl o o d press ure A b n or mal c ha n ges i n pers o nalit y I n a d diti o n, y o u s h o ul d ne ver st o p t he pre d nis o ne s u d de nl y. If y o u nee d t o st o p t he pre d nis o ne, y o ur d oct or will a d vise y o u o n h o w t o sl o wl y st o p t he dr u g (calle d a "ta per"). If y o u were t o st o p ta ki n g pre d nis o ne s u d de nl y, y o u c o ul d bec o me ver y wea k a n d tire d, de vel o p ver y l o w bl o o d press ure, ver y l o w bl o o d s u gar, a n d a b n or malities of t he mi nerals i n y o ur bl o o dstrea m. W hile us uall y n ot se vere, if n ot treate d, t hese a b n or malities are p ote ntiall y fatal. If y o u ha ve a seri o us ill ness, i nfecti o n, or tra u ma, it will be necessar y t o i ncrease y o ur d ose of pre d nis o ne. A n yti me y o u see a d oct or f or a n y reas o n, y o u s h o ul d tell hi m/ her t hat y o u are ta ki n g pre d nis o ne.  
We d o n ot k n o w t he si de effects of ri b ocicli b, d oceta xel, a n d pre d nis o ne w he n gi ve n al o ne or i n c o m bi nati o n wit h ot her dr u gs. A c o m bi nati o n of dr u gs mi g ht res ult i n seri o us or e ve n lifet hreate ni n g si de effects. S o me o ver-t he-c o u nter a n d prescri pti o n me dicati o ns ca n re d uce t he effecti ve ness or i ncrease t he si de effects of t he st u d y treat me nts. Li ke wise, t he st u d y treat me nts ca n i ncrease t he si de effects or lesse n t he effecti ve ness of s o me me dicati o ns. T his mi g ht res ult i n seri o us or e ve n life-t hreate ni n g si de effects. Y o u s h o ul d al wa ys disc uss t he use of a n y dr u gs  
( o ver-t he-c o u nter dr u gs, prescri pti o n, or ille gal dr u gs or healt h f o o d s u p ple me nts) wit h y o ur d oct or w hile y o u are partici pati n g i n t his st u d y. T he st u d y pr ot oc ol descri bes w hic h me dici nes are pr o hi bite d d uri n g t he st u d y, a n d w hic h o nes ca n be ta ke n wit h ca uti o n.  
I R B N U M B E R: 1 5- 1 5 7 4 5 I R B A P P R O V A L D A T E: 0 7/ 2 6/ 2 0 1 9 I R B E X PI R A TI O N D A T E: 0 2/ 1 1/ 2 0 2 0  
  
T here c o ul d be a d diti o nal u ne x pecte d si de effects w he n ri b ocicli b is ta ke n i n c o m bi nati o n wit h d oceta xel a n d pre d nis o ne.

Ras h Hair l oss Fl ui d rete nti o n/s welli n g Fati g ue U pset st o mac h S ore ness a n d/ or wea k ness of m uscles a n d/ or j oi nts P a g e 1 2 of 2 5 C C \# 1 4 5 5 1 5  
```
I ncrease d bl o o d s u gar le vels, w hic h ma y ca use i ncrease d t hirst, uri nati o n, a n d fati g ue

L o were d w hite bl o o d cell c o u nt t hat ma y lea d t o i ncrease d ris k of i nfecti o n

L o were d platelet c o u nt t hat ma y lea d t o i ncrease d br uisi n g or blee di n g

L o were d re d bl o o d cell c o u nt t hat ma y ca use tire d ness or s h ort ness of breat h (if t he c o u nt

gets t o o l o w y o u ma y nee d a tra nsf usi o n)

Less Li kel y




Diarr hea

Na usea a n d v o miti n g

M o ut h a n d t hr oat s ores

L oss of a p petite

L oss of refle xes

Dar ke ni n g or li g hte ni n g of fi n ger nail be ds

Peeli n g s ki n o n ha n ds a n d feet

I ns o m nia

N u m b ness a n d/ or ti n gli n g of t he fi n gers a n d t oes

Rare, b ut seri o us


```  
St o mac h ulcers a n d/ or blee di n g Se vere aller gic reacti o n (life-t hreate ni n g breat hi n g pr o ble ms)  
A b n or mal f u ncti o n of t he a dre nal gla n d w hic h ca n ca use wea k ness a n d fati g ue, l o w bl o o d press ure, na usea, v o miti n g, diarr hea, irrita bilit y a n d/ or restless ness, l oss of b o ne de nsit y L o w bl o o d press ure A b n or mal c ha n ges i n pers o nalit y I n a d diti o n, y o u s h o ul d ne ver st o p t he pre d nis o ne s u d de nl y. If y o u nee d t o st o p t he pre d nis o ne, y o ur d oct or will a d vise y o u o n h o w t o sl o wl y st o p t he dr u g (calle d a "ta per"). If y o u were t o st o p ta ki n g pre d nis o ne s u d de nl y, y o u c o ul d bec o me ver y wea k a n d tire d, de vel o p ver y l o w bl o o d press ure, ver y l o w bl o o d s u gar, a n d a b n or malities of t he mi nerals i n y o ur bl o o dstrea m. W hile us uall y n ot se vere, if n ot treate d, t hese a b n or malities are p ote ntiall y fatal. If y o u ha ve a seri o us ill ness, i nfecti o n, or tra u ma, it will be necessar y t o i ncrease y o ur d ose of pre d nis o ne. A n yti me y o u see a d oct or f or a n y reas o n, y o u s h o ul d tell hi m/ her t hat y o u are ta ki n g pre d nis o ne.  
We d o n ot k n o w t he si de effects of ri b ocicli b, d oceta xel, a n d pre d nis o ne w he n gi ve n al o ne or i n c o m bi nati o n wit h ot her dr u gs. A c o m bi nati o n of dr u gs mi g ht res ult i n seri o us or e ve n lifet hreate ni n g si de effects. S o me o ver-t he-c o u nter a n d prescri pti o n me dicati o ns ca n re d uce t he effecti ve ness or i ncrease t he si de effects of t he st u d y treat me nts. Li ke wise, t he st u d y treat me nts ca n i ncrease t he si de effects or lesse n t he effecti ve ness of s o me me dicati o ns. T his mi g ht res ult i n seri o us or e ve n life-t hreate ni n g si de effects. Y o u s h o ul d al wa ys disc uss t he use of a n y dr u gs  
( o ver-t he-c o u nter dr u gs, prescri pti o n, or ille gal dr u gs or healt h f o o d s u p ple me nts) wit h y o ur d oct or w hile y o u are partici pati n g i n t his st u d y. T he st u d y pr ot oc ol descri bes w hic h me dici nes are pr o hi bite d d uri n g t he st u d y, a n d w hic h o nes ca n be ta ke n wit h ca uti o n. T here c o ul d be a d diti o nal u ne x pecte d si de effects w he n ri b ocicli b is ta ke n i n c o m bi nati o n wit h  
  
d oceta xel a n d pre d nis o ne.

G- C S F ca uses b o ne pai n i n ma n y pe o ple. T his pai n ma y occ ur i m me diatel y or se veral da ys after recei vi n g G- C S F. T he pai n ma y feel li ke a n ac hi n g se nsati o n i n t he b o nes of t he bac k, hi ps, pel vis, or breast b o ne. Pai n relie vers, s uc h as aceta mi n o p he n ( T yle n ol ®) or i b u pr ofe n ( A d vil ®,  
N u pri n ®) ma y be use d t o lesse n t his disc o mf ort.  
Occasi o nall y, G- C S F ma y ca use fl u-li ke s y m pt o ms. If y o u alrea d y ha ve i nfla m mati o n of certai n bl o o d vessels, art hritis, ecze ma or ps oriasis, G- C S F ma y ca use t hese c o n diti o ns t o get w orse.  
Ot her occasi o nal si de effects i ncl u de hea dac hes, m uscle ac hes, tire d ness, na usea a n d v o miti n g, a n d tr o u ble slee pi n g. T hese s y m pt o ms us uall y g o a wa y wit hi n 2 or 3 da ys after st o p pi n g G- C S F.  
T he f oll o wi n g si de effects are rare a n d are n ot ge nerall y seri o us pr o ble ms:  
B ur ni n g, s welli n g, a n d re d ness at t he i njecti o n site Aller gic reacti o ns ( hi ves/s ki n ras h, itc hi n g, w heezi n g, fe ver, ra pi d heart rate, s h ort ness of breat h, dizzi ness)  
L o weri n g of bl o o d press ure C ha n ges i n bl o o d c he mistr y le vels E nlar ge me nt of t he s plee n (see n i n s o me patie nts treate d wit h G- C S F f or a n e xte n de d peri o d of ti me)  
Rare b ut seri o us:  
Se vere reacti o ns t o G- C S F i n patie nts wit h sic kle cell a ne mia a n d relate d sic kle cell diseases.  
Pai n a n d blee di n g fr o m t he s plee n, w hic h ma y re q uire s ur ger y. If y o u feel pai n i n y o ur u p per left si de j ust bel o w t he ri b ca ge, c o ntact y o ur d oct or i m me diatel y.

G- C S F ca uses b o ne pai n i n ma n y pe o ple. T his pai n ma y occ ur i m me diatel y or se veral da ys after recei vi n g G- C S F. T he pai n ma y feel li ke a n ac hi n g se nsati o n i n t he b o nes of t he bac k, hi ps, pel vis, or breast b o ne. Pai n relie vers, s uc h as aceta mi n o p he n ( T yle n ol ®) or i b u pr ofe n ( A d vil ®,  
N u pri n ®) ma y be use d t o lesse n t his disc o mf ort.  
Occasi o nall y, G- C S F ma y ca use fl u-li ke s y m pt o ms. If y o u alrea d y ha ve i nfla m mati o n of certai n bl o o d vessels, art hritis, ecze ma or ps oriasis, G- C S F ma y ca use t hese c o n diti o ns t o get w orse.  
Ot her occasi o nal si de effects i ncl u de hea dac hes, m uscle ac hes, tire d ness, na usea a n d v o miti n g, a n d tr o u ble slee pi n g. T hese s y m pt o ms us uall y g o a wa y wit hi n 2 or 3 da ys after st o p pi n g G- C S F.  
T he f oll o wi n g si de effects are rare a n d are n ot ge nerall y seri o us pr o ble ms:  
B ur ni n g, s welli n g, a n d re d ness at t he i njecti o n site Aller gic reacti o ns ( hi ves/s ki n ras h, itc hi n g, w heezi n g, fe ver, ra pi d heart rate, s h ort ness of breat h, dizzi ness)  
L o weri n g of bl o o d press ure C ha n ges i n bl o o d c he mistr y le vels E nlar ge me nt of t he s plee n (see n i n s o me patie nts treate d wit h G- C S F f or a n e xte n de d peri o d of ti me)  
Rare b ut seri o us:  
Se vere reacti o ns t o G- C S F i n patie nts wit h sic kle cell a ne mia a n d relate d sic kle cell diseases.  
Pai n a n d blee di n g fr o m t he s plee n, w hic h ma y re q uire s ur ger y. If y o u feel pai n i n y o ur u p per left si de j ust bel o w t he ri b ca ge, c o ntact y o ur d oct or i m me diatel y.

Bl o o d dr a wi n g ( ve ni p u nct ure) ris ks: Dra wi n g bl o o d ma y ca use te m p orar y disc o mf ort fr o m t he nee dle stic k, br uisi n g, a n d i nfecti o n. I n rare i nsta nces w here a n urse, a d oct or, or a la b orat or y tec h nicia n s ustai ns a n e x p os ure t o y o ur bl o o d, tiss ue or b o d y fl ui ds b y nee dle stic k, c ut or s plas h t o m uc osa or da ma ge d s ki n, it ma y be necessar y t o test y o ur bl o o d, tiss ue, or b o d y fl ui d sa m ple f or certai n viral i nfecti o ns i ncl u di n g He patitis B a n d C a n d HI V o n t he sa m ple alrea d y a vaila ble.  
T his is t o e na ble t hat pers o n t o recei ve a p pr o priate c o u nseli n g, m o nit ori n g, a n d treat me nt if necessar y. I n t his i nsta nce, t he St u d y D oct or will offer y o u t he i nf or mati o n rele va nt t o y o ur healt h a n d a d vise y o u o n t he ne xt ste ps. C o nfi de ntialit y of y o ur data will be res pecte d at all ti mes.  
  
C T sc a n ris ks: C T sca ns i n v ol ve t he ris ks of ra diati o n. I n a d diti o n, if c o ntrast material (i o di ne d ye) is use d, t here is a sli g ht ris k of de vel o pi n g a n aller gic reacti o n. T he aller gic reacti o n ca n be mil d (itc hi n g, ras h) t o se vere ( diffic ult y breat hi n g, s h oc k, or rarel y, deat h). T he c o ntrast material ma y als o ca use ki d ne y pr o ble ms, es peciall y if y o u are de h y drate d or ha ve p o or ki d ne y f u ncti o n.  
T he st u d y d oct ors will as k y o u a b o ut a n y aller gies or relate d c o n diti o ns y o u ma y ha ve bef ore t he pr oce d ure is d o ne. If y o u ha ve a n y of t hese aller gies or c o n diti o ns, y o u ma y n ot be all o we d t o  
```
ha ve a C T sca n i n t he st u d y.

Ha vi n g a C T sca n ma y mea n s o me a d de d disc o mf ort f or y o u. I n partic ular, y o u ma y be b ot here d

b y feeli n gs of cla ustr o p h o bia w he n place d i nsi de t he C T sca n ner, or b y l yi n g i n a still p ositi o n

f or a l o n g ti me. If c o ntrast material is use d, y o u ma y feel disc o mf ort w he n it is i njecte d i nt o y o ur

b o d y. Y o u ma y feel war m a n d fl us he d a n d/ or get a metallic taste i n y o ur m o ut h. Rarel y, t he

c o ntrast material ma y ca use na usea, v o miti n g or a hea dac he.

M RI ris ks : Beca use t he M RI mac hi ne acts li ke a lar ge ma g net, it c o ul d m o ve ir o n-c o ntai ni n g

o bjects i n t he M RI r o o m d uri n g y o ur e xa mi nati o n, w hic h i n t he pr ocess c o ul d p ossi bl y har m

y o u. Preca uti o ns ha ve bee n ta ke n t o pre ve nt s uc h a n e ve nt fr o m ha p pe ni n g; l o ose metal o bjects,

li ke p oc ket k ni ves or ke y c hai ns, are n ot all o we d i n t he M RI r o o m. If y o u ha ve a piece of metal

i n y o ur b o d y, s uc h as a fra g me nt i n y o ur e ye, a ne ur ys m cli ps, ear i m pla nts, s pi nal ner ve

sti m ulat ors, or a pace ma ker, y o u will n ot be all o we d i nt o t he M RI r o o m a n d ca n n ot ha ve a n

M RI.

Ha vi n g a n M RI ma y mea n s o me a d de d disc o mf ort f or y o u. I n partic ular, y o u ma y be b ot here d b y

feeli n gs of cla ustr o p h o bia a n d b y t he l o u d ba n gi n g n oise d uri n g t he st u d y. Te m p orar y heari n g

l oss has bee n re p orte d fr o m t his l o u d n oise. T his is w h y y o u will be as ke d t o wear ear pl u gs. At

ti mes d uri n g t he test, y o u ma y be as ke d t o n ot s wall o w f or a w hile, w hic h ca n feel

u nc o mf orta ble.

C o ntr ast a ge nt ( g a d oli ni u m) ris ks : A fe w si de effects of ga d oli ni u m i njecti o n s uc h as

mil d hea dac he, na usea, a n d l ocal pai n ma y occ ur. Rarel y, (less t ha n 1 % of t he ti me) l o w

bl o o d press ure a n d li g ht hea de d ness ma y occ ur. T his ca n be treate d i m me diatel y wit h

fl ui ds gi ve n t hr o u g h o ne of y o ur vei ns. Ver y rarel y, (less t ha n o ne i n o ne t h o usa n d),

patie nts are aller gic t o ga d oli ni u m. T hese aller gic effects m ost c o m m o nl y i ncl u de hi ves

a n d itc h y e yes, b ut m ore se vere reacti o ns, i ncl u di n g s h ort ness of breat h, ha ve bee n see n.

Patie nts wit h se vere ki d ne y disease s o meti mes ha ve a ba d reacti o n t o t he ga d oli ni u m

c o ntrast material. T his c o n diti o n is calle d ne p hr o ge nic s yste mic fi br osis ( N S F). It ca n

ca use s ki n t o ti g hte n or scar a n d ca n da ma ge i nter nal or ga ns. S o meti mes it ca n be lifet hreate ni n g. T here are n o re p orts of N S F i n patie nts wit h n or mal ki d ne y f u ncti o n.

Bef ore y o u ha ve a n M RI sca n re q uiri n g a n i njecti o n of ga d oli ni u m c o ntrast, y o u will

nee d t o ha ve a bl o o d test i n or der t o c hec k t he f u ncti o n of y o ur ki d ne ys. Base d o n y o ur

me dical hist or y a n d t he res ults of t his test, a d oct or will deci de w het her it is safe f or y o u

t o u n der g o t he M RI sca ns.


```  
  
B o ne sc a n ris k : A b o ne sca n i n v ol ves e x p os ure t o ra diati o n. ( See Ra diati o n Ris ks bel o w). S o me pe o ple ma y ha ve a cl ose d-i n feeli n g w hile u n der t he ca mera. As i n a n y i njecti o n, y o u ma y ha ve s welli n g or br uisi n g at t he i njecti o n site.  
R a di ati o n ris ks: T his researc h st u d y i n v ol ves e x p os ure t o ra diati o n. N ot all t his ra diati o n e x p os ure is necessar y f or y o ur me dical care a n d is f or researc h p ur p oses o nl y. T his a m o u nt of ra diati o n ma y i n v ol ve a l o w ris k of ca ncer. H o we ver, we belie ve t hat t his ris k, gi ve n y o ur o verall me dical c o n diti o n is n ot cli nicall y rele va nt. If y o u ha ve a n y q uesti o ns re gar di n g t he use of ra diati o n or t he ris ks i n v ol ve d, please c o ns ult t he p h ysicia n c o n d ucti n g t he st u d y.  
Electr oc ar di o gr a m ( E K G/ E C G) ris ks: T he E C G i n v ol ves placi n g electr o des o n t he s ki n. Y o u ma y e x perie nce a n aller gic reacti o n t o t he a d hesi ve use d t o attac h t he electr o des t o t he s ki n.  
T hese s y m pt o ms are ge nerall y mil d a n d clear u p o n t heir o w n. Please let y o ur d oct or k n o w if y o u are a ware of a n y aller gies.  
Ec h oc ar di o gr a m ( E C H O): T he car diac ec h o gra m mi g ht ca use y o u t o be u nc o mf orta ble fr o m t he press ure of t he pr o be o n y o ur c hest or l yi n g still f or t he e xa mi nati o n.  
M U G A sc a n ris ks : M U G A sca ns i n v ol ve t he ris ks of ra diati o n ( See Ra diati o n Ris ks a b o ve).  
Y o u ma y de vel o p br uisi n g w here t he nee dle is place d i n y o ur vei ns t o a d mi nister t he ra di oacti ve s u bsta nce. Y o u ma y be u nc o mf orta ble l yi n g flat.  
S afe H a n dli n g of Me dic ati o ns: Ha n dli n g ri b ocicli b a n d ha vi n g c o ntact wit h a n y uri ne, feces, or v o mit fr o m patie nts recei vi n g ri b ocicli b ma y p ose s o me ris k t o y o u a n d y o ur care gi vers. T o a v oi d e x p os ure t o ri b ocicli b a n d a n y ass ociate d ris ks, y o u a n d y o ur fa mil y me m bers/care gi vers will be e d ucate d b y a me m ber of t he st u d y tea m o n h o w t o safel y ha n dle, pr o perl y dis p ose of, a n d clea n pr o d ucts t hat ma y be c o nta mi nate d wit h ri b ocicli b.  
D ose Esc al ati o n Ris ks: Si nce patie nts will be assi g ne d t o differe nt d oses of st u d y dr u g, s o me patie nts ma y recei ve a d ose of t he dr u g t hat is t o o s mall t o be effecti ve w hile ot hers ma y recei ve a hi g her d ose t hat ma y ca use i ncrease d si de effects. Y o u ca n as k y o ur st u d y d oct or w hat d ose y o u will be gi ve n.  
Re pr o d ucti ve Ris ks: Y o u s h o ul d n ot fat her a ba b y w hile o n t his st u d y beca use t he dr u gs i n t his st u d y ca n affect a n u n b or n ba b y. It is i m p orta nt t o u n dersta n d t hat y o u nee d t o use birt h c o ntr ol w hile o n t his st u d y. Y o u m ust al wa ys wear a c o n d o m d uri n g i nterc o urse (e ve n if y o u ha ve ha d a vasect o m y), a n d if fertile y o u m ust als o use s per mici de. Y o u m ust c o nti n ue t o wear a c o n d o m w hile ta ki n g t he dr u g a n d f or 3 0 da ys after st o p pi n g treat me nt. F or m ore i nf or mati o n re gar di n g c o ntrace pti o n please s pea k t o y o ur st u d y d oct or.  
U n k n o w n Ris ks: T he e x peri me ntal treat me nts ma y ha ve si de effects t hat n o o ne k n o ws a b o ut.  
T he researc hers will let y o u k n o w if t he y lear n a n yt hi n g t hat mi g ht ma ke y o u c ha n ge y o ur mi n d a b o ut partici pati n g i n t he st u d y.  
F or m ore i nf or mati o n a b o ut ris ks a n d si de effects, as k y o ur st u d y d oct or.

Bl o o d dr a wi n g ( ve ni p u nct ure) ris ks: Dra wi n g bl o o d ma y ca use te m p orar y disc o mf ort fr o m t he nee dle stic k, br uisi n g, a n d i nfecti o n. I n rare i nsta nces w here a n urse, a d oct or, or a la b orat or y tec h nicia n s ustai ns a n e x p os ure t o y o ur bl o o d, tiss ue or b o d y fl ui ds b y nee dle stic k, c ut or s plas h t o m uc osa or da ma ge d s ki n, it ma y be necessar y t o test y o ur bl o o d, tiss ue, or b o d y fl ui d sa m ple f or certai n viral i nfecti o ns i ncl u di n g He patitis B a n d C a n d HI V o n t he sa m ple alrea d y a vaila ble.  
T his is t o e na ble t hat pers o n t o recei ve a p pr o priate c o u nseli n g, m o nit ori n g, a n d treat me nt if necessar y. I n t his i nsta nce, t he St u d y D oct or will offer y o u t he i nf or mati o n rele va nt t o y o ur healt h a n d a d vise y o u o n t he ne xt ste ps. C o nfi de ntialit y of y o ur data will be res pecte d at all ti mes. C T sc a n ris ks: C T sca ns i n v ol ve t he ris ks of ra diati o n. I n a d diti o n, if c o ntrast material (i o di ne  
  
d ye) is use d, t here is a sli g ht ris k of de vel o pi n g a n aller gic reacti o n. T he aller gic reacti o n ca n be mil d (itc hi n g, ras h) t o se vere ( diffic ult y breat hi n g, s h oc k, or rarel y, deat h). T he c o ntrast material ma y als o ca use ki d ne y pr o ble ms, es peciall y if y o u are de h y drate d or ha ve p o or ki d ne y f u ncti o n.  
T he st u d y d oct ors will as k y o u a b o ut a n y aller gies or relate d c o n diti o ns y o u ma y ha ve bef ore t he pr oce d ure is d o ne. If y o u ha ve a n y of t hese aller gies or c o n diti o ns, y o u ma y n ot be all o we d t o  
```
ha ve a C T sca n i n t he st u d y.

Ha vi n g a C T sca n ma y mea n s o me a d de d disc o mf ort f or y o u. I n partic ular, y o u ma y be b ot here d

b y feeli n gs of cla ustr o p h o bia w he n place d i nsi de t he C T sca n ner, or b y l yi n g i n a still p ositi o n

f or a l o n g ti me. If c o ntrast material is use d, y o u ma y feel disc o mf ort w he n it is i njecte d i nt o y o ur

b o d y. Y o u ma y feel war m a n d fl us he d a n d/ or get a metallic taste i n y o ur m o ut h. Rarel y, t he

c o ntrast material ma y ca use na usea, v o miti n g or a hea dac he.

M RI ris ks : Beca use t he M RI mac hi ne acts li ke a lar ge ma g net, it c o ul d m o ve ir o n-c o ntai ni n g

o bjects i n t he M RI r o o m d uri n g y o ur e xa mi nati o n, w hic h i n t he pr ocess c o ul d p ossi bl y har m

y o u. Preca uti o ns ha ve bee n ta ke n t o pre ve nt s uc h a n e ve nt fr o m ha p pe ni n g; l o ose metal o bjects,

li ke p oc ket k ni ves or ke y c hai ns, are n ot all o we d i n t he M RI r o o m. If y o u ha ve a piece of metal

i n y o ur b o d y, s uc h as a fra g me nt i n y o ur e ye, a ne ur ys m cli ps, ear i m pla nts, s pi nal ner ve

sti m ulat ors, or a pace ma ker, y o u will n ot be all o we d i nt o t he M RI r o o m a n d ca n n ot ha ve a n

M RI.

Ha vi n g a n M RI ma y mea n s o me a d de d disc o mf ort f or y o u. I n partic ular, y o u ma y be b ot here d b y

feeli n gs of cla ustr o p h o bia a n d b y t he l o u d ba n gi n g n oise d uri n g t he st u d y. Te m p orar y heari n g

l oss has bee n re p orte d fr o m t his l o u d n oise. T his is w h y y o u will be as ke d t o wear ear pl u gs. At

ti mes d uri n g t he test, y o u ma y be as ke d t o n ot s wall o w f or a w hile, w hic h ca n feel

u nc o mf orta ble.

C o ntr ast a ge nt ( g a d oli ni u m) ris ks : A fe w si de effects of ga d oli ni u m i njecti o n s uc h as

mil d hea dac he, na usea, a n d l ocal pai n ma y occ ur. Rarel y, (less t ha n 1 % of t he ti me) l o w

bl o o d press ure a n d li g ht hea de d ness ma y occ ur. T his ca n be treate d i m me diatel y wit h

fl ui ds gi ve n t hr o u g h o ne of y o ur vei ns. Ver y rarel y, (less t ha n o ne i n o ne t h o usa n d),

patie nts are aller gic t o ga d oli ni u m. T hese aller gic effects m ost c o m m o nl y i ncl u de hi ves

a n d itc h y e yes, b ut m ore se vere reacti o ns, i ncl u di n g s h ort ness of breat h, ha ve bee n see n.

Patie nts wit h se vere ki d ne y disease s o meti mes ha ve a ba d reacti o n t o t he ga d oli ni u m

c o ntrast material. T his c o n diti o n is calle d ne p hr o ge nic s yste mic fi br osis ( N S F). It ca n

ca use s ki n t o ti g hte n or scar a n d ca n da ma ge i nter nal or ga ns. S o meti mes it ca n be lifet hreate ni n g. T here are n o re p orts of N S F i n patie nts wit h n or mal ki d ne y f u ncti o n.

Bef ore y o u ha ve a n M RI sca n re q uiri n g a n i njecti o n of ga d oli ni u m c o ntrast, y o u will

nee d t o ha ve a bl o o d test i n or der t o c hec k t he f u ncti o n of y o ur ki d ne ys. Base d o n y o ur

me dical hist or y a n d t he res ults of t his test, a d oct or will deci de w het her it is safe f or y o u

t o u n der g o t he M RI sca ns.

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B o ne sc a n ris k : A b o ne sca n i n v ol ves e x p os ure t o ra diati o n. ( See Ra diati o n Ris ks bel o w). S o me  
  
pe o ple ma y ha ve a cl ose d-i n feeli n g w hile u n der t he ca mera. As i n a n y i njecti o n, y o u ma y ha ve s welli n g or br uisi n g at t he i njecti o n site.  
R a di ati o n ris ks: T his researc h st u d y i n v ol ves e x p os ure t o ra diati o n. N ot all t his ra diati o n e x p os ure is necessar y f or y o ur me dical care a n d is f or researc h p ur p oses o nl y. T his a m o u nt of ra diati o n ma y i n v ol ve a l o w ris k of ca ncer. H o we ver, we belie ve t hat t his ris k, gi ve n y o ur o verall me dical c o n diti o n is n ot cli nicall y rele va nt. If y o u ha ve a n y q uesti o ns re gar di n g t he use of ra diati o n or t he ris ks i n v ol ve d, please c o ns ult t he p h ysicia n c o n d ucti n g t he st u d y.  
Electr oc ar di o gr a m ( E K G/ E C G) ris ks: T he E C G i n v ol ves placi n g electr o des o n t he s ki n. Y o u ma y e x perie nce a n aller gic reacti o n t o t he a d hesi ve use d t o attac h t he electr o des t o t he s ki n.  
T hese s y m pt o ms are ge nerall y mil d a n d clear u p o n t heir o w n. Please let y o ur d oct or k n o w if y o u are a ware of a n y aller gies.  
Ec h oc ar di o gr a m ( E C H O): T he car diac ec h o gra m mi g ht ca use y o u t o be u nc o mf orta ble fr o m t he press ure of t he pr o be o n y o ur c hest or l yi n g still f or t he e xa mi nati o n.  
M U G A sc a n ris ks : M U G A sca ns i n v ol ve t he ris ks of ra diati o n ( See Ra diati o n Ris ks a b o ve).  
Y o u ma y de vel o p br uisi n g w here t he nee dle is place d i n y o ur vei ns t o a d mi nister t he ra di oacti ve s u bsta nce. Y o u ma y be u nc o mf orta ble l yi n g flat.  
S afe H a n dli n g of Me dic ati o ns: Ha n dli n g ri b ocicli b a n d ha vi n g c o ntact wit h a n y uri ne, feces, or v o mit fr o m patie nts recei vi n g ri b ocicli b ma y p ose s o me ris k t o y o u a n d y o ur care gi vers. T o a v oi d e x p os ure t o ri b ocicli b a n d a n y ass ociate d ris ks, y o u a n d y o ur fa mil y me m bers/care gi vers will be e d ucate d b y a me m ber of t he st u d y tea m o n h o w t o safel y ha n dle, pr o perl y dis p ose of, a n d clea n pr o d ucts t hat ma y be c o nta mi nate d wit h ri b ocicli b.  
D ose Esc al ati o n Ris ks: Si nce patie nts will be assi g ne d t o differe nt d oses of st u d y dr u g, s o me patie nts ma y recei ve a d ose of t he dr u g t hat is t o o s mall t o be effecti ve w hile ot hers ma y recei ve a hi g her d ose t hat ma y ca use i ncrease d si de effects. Y o u ca n as k y o ur st u d y d oct or w hat d ose y o u will be gi ve n.  
Re pr o d ucti ve Ris ks: Y o u s h o ul d n ot fat her a ba b y w hile o n t his st u d y beca use t he dr u gs i n t his st u d y ca n affect a n u n b or n ba b y. It is i m p orta nt t o u n dersta n d t hat y o u nee d t o use birt h c o ntr ol w hile o n t his st u d y. Y o u m ust al wa ys wear a c o n d o m d uri n g i nterc o urse (e ve n if y o u ha ve ha d a vasect o m y), a n d if fertile y o u m ust als o use s per mici de. Y o u m ust c o nti n ue t o wear a c o n d o m w hile ta ki n g t he dr u g a n d f or 3 0 da ys after st o p pi n g treat me nt. F or m ore i nf or mati o n re gar di n g c o ntrace pti o n please s pea k t o y o ur st u d y d oct or.  
U n k n o w n Ris ks: T he e x peri me ntal treat me nts ma y ha ve si de effects t hat n o o ne k n o ws a b o ut.  
T he researc hers will let y o u k n o w if t he y lear n a n yt hi n g t hat mi g ht ma ke y o u c ha n ge y o ur mi n d a b o ut partici pati n g i n t he st u d y.  
F or m ore i nf or mati o n a b o ut ris ks a n d si de effects, as k y o ur st u d y d oct or.

Ta ki n g part i n t his st u d y ma y or ma y n ot ma ke y o ur healt h better. W hile d oct ors h o pe t hat t he c o m bi nati o n of ri b ocicli b wit h d oceta xel pl us pre d nis o ne will be m ore usef ul a gai nst ca ncer c o m pare d t o t he us ual treat me nt, t here is n o pr o of of t his. Y o ur c o n diti o n ma y e ve n get w orse d uri n g t he st u d y. We d o k n o w t hat t he i nf or mati o n fr o m t his st u d y will hel p d oct ors lear n m ore a b o ut t heses st u d y dr u g c o m bi nati o ns as a treat me nt f or ca ncer. T his i nf or mati o n c o ul d hel p f ut ure ca ncer patie nts. H o we ver, t here is n o g uara ntee t hat t his will ha p pe n.

Ta ki n g part i n t his st u d y ma y or ma y n ot ma ke y o ur healt h better. W hile d oct ors h o pe t hat t he c o m bi nati o n of ri b ocicli b wit h d oceta xel pl us pre d nis o ne will be m ore usef ul a gai nst ca ncer c o m pare d t o t he us ual treat me nt, t here is n o pr o of of t his. Y o ur c o n diti o n ma y e ve n get w orse d uri n g t he st u d y. We d o k n o w t hat t he i nf or mati o n fr o m t his st u d y will hel p d oct ors lear n m ore a b o ut t heses st u d y dr u g c o m bi nati o ns as a treat me nt f or ca ncer. T his i nf or mati o n c o ul d hel p f ut ure ca ncer patie nts. H o we ver, t here is n o g uara ntee t hat t his will ha p pe n.

It is i m p orta nt t hat y o u tell y o ur st u d y d oct or, Ra h ul A g gar wal, M. D., if y o u feel t hat y o u ha ve bee n i nj ure d beca use of ta ki n g part i n t his st u d y. Y o u ca n tell t he d oct or i n pers o n or call Tre at me nt a n d C o m pe ns ati o n f or I nj ur y: If y o u are i nj ure d as a res ult of bei n g i n t his st u d y, t he U ni versit y of Calif or nia will pr o vi de necessar y me dical treat me nt. T he c osts of t he treat me nt ma y be bille d t o y o u or y o ur i ns urer j ust li ke a n y ot her me dical c osts, or c o vere d b y t he U ni versit y of Calif or nia, de pe n di n g o n a n u m ber of fact ors. T he U ni versit y a n d t he st u d y s p o ns or d o n ot n or mall y pr o vi de a n y ot her f or m of c o m pe nsati o n f or i nj ur y. F or f urt her i nf or mati o n a b o ut t his, y o u ma y call t he office of t he C o m mittee o n H u ma n Researc h at 4 1 5- 4 7 6- 1 8 1 4.

It is i m p orta nt t hat y o u tell y o ur st u d y d oct or, Ra h ul A g gar wal, M. D., if y o u feel t hat y o u ha ve bee n i nj ure d beca use of ta ki n g part i n t his st u d y. Y o u ca n tell t he d oct or i n pers o n or call Tre at me nt a n d C o m pe ns ati o n f or I nj ur y: If y o u are i nj ure d as a res ult of bei n g i n t his st u d y, t he U ni versit y of Calif or nia will pr o vi de necessar y me dical treat me nt. T he c osts of t he treat me nt ma y be bille d t o y o u or y o ur i ns urer j ust li ke a n y ot her me dical c osts, or c o vere d b y t he U ni versit y of Calif or nia, de pe n di n g o n a n u m ber of fact ors. T he U ni versit y a n d t he st u d y s p o ns or d o n ot n or mall y pr o vi de a n y ot her f or m of c o m pe nsati o n f or i nj ur y. F or f urt her i nf or mati o n a b o ut t his, y o u ma y call t he office of t he C o m mittee o n H u ma n Researc h at 4 1 5- 4 7 6- 1 8 1 4.

T he researc h t hat ma y be d o ne wit h y o ur bl o o d sa m ple is n ot desi g ne d s pecificall y t o hel p y o u. It mi g ht hel p pe o ple w h o ha ve ca ncer a n d ot her diseases i n t he f ut ure. T he be nefits of researc h usi n g bl o o d sa m ple i ncl u de lear ni n g m ore a b o ut w hat ca uses ca ncer a n d ot her diseases, h o w t o pre ve nt t he m, a n d h o w t o treat t he m.  
U C S F will be t he e xcl usi ve o w ner of a n y data a n d disc o veries res ulti n g fr o m t his researc h.  
A n y c o m mercial pr o d uct de vel o pe d at U C S F as a res ult of t hese st u dies w o ul d be fr o m t he a nal ysis of all sa m ples c ollecte d i n t his st u d y, n ot fr o m a n i n di vi d ual s u bject's sa m ple.

T he researc h t hat ma y be d o ne wit h y o ur bl o o d sa m ple is n ot desi g ne d s pecificall y t o hel p y o u. It mi g ht hel p pe o ple w h o ha ve ca ncer a n d ot her diseases i n t he f ut ure. T he be nefits of researc h usi n g bl o o d sa m ple i ncl u de lear ni n g m ore a b o ut w hat ca uses ca ncer a n d ot her diseases, h o w t o pre ve nt t he m, a n d h o w t o treat t he m.  
U C S F will be t he e xcl usi ve o w ner of a n y data a n d disc o veries res ulti n g fr o m t his researc h.  
A n y c o m mercial pr o d uct de vel o pe d at U C S F as a res ult of t hese st u dies w o ul d be fr o m t he a nal ysis of all sa m ples c ollecte d i n t his st u d y, n ot fr o m a n i n di vi d ual s u bject's sa m ple.

T here is s o me ris k fr o m a breac h of c o nfi de ntialit y. We will d o o ur best t o ma ke s ure t hat y o ur pers o nal i nf or mati o n will be ke pt pri vate.  
T he c ha nce t hat t his i nf or mati o n will be gi ve n t o s o me o ne else is ver y s mall.  
If t his i nf or mati o n were release d t o y o u, y o ur fa mil y, or t hir d parties, it c o ul d p ote ntiall y be mis use d. S uc h mis use c o ul d lea d t o a d verse ps yc h ol o gical effects or u n desire d effects o n t he a bilit y of y o u or y o ur fa mil y me m bers t o o btai n a j o b or i ns ura nce.  
T he t y pes of me dical i nf or mati o n t hat c o ul d be c ollecte d are y o ur pre vi o us me dical hist or y, la b orat or y val ues, t y pe of ca ncer, a n d t u m or sta gi n g.  
  
I n or der t o mi ni mize t hese p ote ntial ris ks, all researc h i nf or mati o n o btai ne d f or y o ur bl o o d sa m ple a n d me dical rec or ds will be ke pt c o nfi de ntial as descri be d a b o ve.

T here is s o me ris k fr o m a breac h of c o nfi de ntialit y. We will d o o ur best t o ma ke s ure t hat y o ur pers o nal i nf or mati o n will be ke pt pri vate.  
T he c ha nce t hat t his i nf or mati o n will be gi ve n t o s o me o ne else is ver y s mall.  
If t his i nf or mati o n were release d t o y o u, y o ur fa mil y, or t hir d parties, it c o ul d p ote ntiall y be mis use d. S uc h mis use c o ul d lea d t o a d verse ps yc h ol o gical effects or u n desire d effects o n t he a bilit y of y o u or y o ur fa mil y me m bers t o o btai n a j o b or i ns ura nce.  
T he t y pes of me dical i nf or mati o n t hat c o ul d be c ollecte d are y o ur pre vi o us me dical hist or y, la b orat or y val ues, t y pe of ca ncer, a n d t u m or sta gi n g. I n or der t o mi ni mize t hese p ote ntial ris ks, all researc h i nf or mati o n o btai ne d f or y o ur bl o o d  
  
sa m ple a n d me dical rec or ds will be ke pt c o nfi de ntial as descri be d a b o ve.

Ris ks are p ossi ble si de effects of st u d y me dici ne, or u n der g oi n g tests, s uc h as i ma gi n g sca ns a n d bl o o d or t u m or sa m ple c ollecti o n.  
T he p ote ntial si de effects descri be d bel o w f or ri b ocicli b are base d o n tests i n a ni mals a n d e x perie nce i n ca ncer s u bjects. It is p ossi ble t hat y o u ma y e x perie nce si de effects t hat are u ne x pecte d a n d u nf oresee n. E ver y o ne ta ki n g part i n t he st u d y will be watc he d caref ull y f or a n y si de effects. Pre ve nti n g si de effects, w he n p ossi ble, is a n i m p orta nt part of all ca ncer care.  
T he p ote ntial si de effects descri be d bel o w f or ri b ocicli b a n d B Y L 7 1 9 are base d o n tests i n a ni mals a n d e x perie nce i n ca ncer patie nts. T he p ote ntial si de effects descri be d bel o w f or letr oz ole are base d o n e xte nsi ve e x perie nce i n ca ncer patie nts. It is p ossi ble t hat y o u ma y e x perie nce si de effects t hat are t otall y u ne x pecte d a n d u nf oresee n. E ver y o ne ta ki n g part i n t he st u d y will be watc he d caref ull y f or a n y si de effects, a n d tr yi n g t o pre ve nt t he m, w he n p ossi ble, is a n i m p orta nt part of all ca ncer care.

Ris ks are p ossi ble si de effects of st u d y me dici ne, or u n der g oi n g tests, s uc h as i ma gi n g sca ns a n d bl o o d or t u m or sa m ple c ollecti o n.  
T he p ote ntial si de effects descri be d bel o w f or ri b ocicli b are base d o n tests i n a ni mals a n d e x perie nce i n ca ncer s u bjects. It is p ossi ble t hat y o u ma y e x perie nce si de effects t hat are u ne x pecte d a n d u nf oresee n. E ver y o ne ta ki n g part i n t he st u d y will be watc he d caref ull y f or a n y si de effects. Pre ve nti n g si de effects, w he n p ossi ble, is a n i m p orta nt part of all ca ncer care.  
T he p ote ntial si de effects descri be d bel o w f or ri b ocicli b a n d B Y L 7 1 9 are base d o n tests i n a ni mals a n d e x perie nce i n ca ncer patie nts. T he p ote ntial si de effects descri be d bel o w f or letr oz ole are base d o n e xte nsi ve e x perie nce i n ca ncer patie nts. It is p ossi ble t hat y o u ma y e x perie nce si de effects t hat are t otall y u ne x pecte d a n d u nf oresee n. E ver y o ne ta ki n g part i n t he st u d y will be watc he d caref ull y f or a n y si de effects, a n d tr yi n g t o pre ve nt t he m, w he n p ossi ble, is a n i m p orta nt part of all ca ncer care.

Ri b ocicli b is a n i n vesti gati o nal dr u g a n d n ot all of t he si de effects are k n o w n. Seri o us si de effects, i ncl u di n g deat h, are a p ossi bilit y. T he l o n g-ter m effects of ri b ocicli b are als o u n k n o w n.  
Ris ks are p ossi ble si de effects of st u d y me dici ne gi ve n al o ne or i n c o m bi nati o n wit h ot her me dicati o n(s), a n d t h ose of ta ki n g bl o o d. Base d o n t he data fr o m o n g oi n g st u dies i n ca ncer patie nts, t he f oll o wi n g are t he p ossi ble ris ks wit h ta ki n g ri b ocicli b.  
Ver y c o m m o n si de effects m ay affect m ore t h a n 1 0 % of pe o ple  
L o w w hite bl o o d cell c o u nt w hic h i ncreases t he ris k of i nfecti o ns ( ne utr o pe nia or le u k o pe nia)  
I nfecti o ns (i ncl u di n g uri nar y tract i nfecti o ns, res pirat or y i nfecti o ns, gastr oe nteritis a n d se vere, p ote ntiall y life-t hreate ni n g i nfecti o ns [se psis; t his is u nc o m m o n])  
L o w re d bl o o d cell c o u nt w hic h ca n lea d t o tire d ness a n d wea k ness (a ne mia)  
  
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Na usea

Diarr hea

V o miti n g

C o nsti pati o n

M o ut h s ores, or pai n, i nfla m mati o n a n d/ or i nfecti o n of t he m o ut h

A b d o mi nal pai n

Tire d ness or ge neralize d wea k ness (fati g ue or ast he nia)

S welli n g of t he ar ms or le gs ( peri p heral oe de ma)

Fe ver ( p yre xia)

I ncrease i n t he bl o o d le vels of li ver para meters as i n dicate d b y li ver tests (s uc h as

tra nsa mi nases a n d/ or bilir u bi n)

Decrease d a p petite

Bac k pai n

Hea dac he

Dizzi ness

S h ort ness of breat h ( d ys p nea)

C o u g h

Hair t hi n ni n g or l oss (al o pecia)

S ki n ras h

Itc hi n g of t he s ki n ( pr urit us)

C o m m o n si de effects m ay affect u p t o 1 0 % of pe o ple


```  
L o w platelet c o u nt w hic h ca n lea d t o eas y br uisi n g a n d blee di n g (t hr o m b oc yt o pe nia)  
L o w w hite bl o o d cell c o u nt wit h fe ver (fe brile ne utr o pe nia)  
L o w l y m p h oc yte c o u nt i n t he bl o o d t hat ca n pre dis p ose t o i nfecti o ns (l y m p h o pe nia)  
Fai nti n g e pis o des/tra nsie nt l oss of c o nsci o us ness a n d p ost ural p ost ure (s y nc o pe)  
E xcessi ve teari n g of t he e ye (i ncrease d lacri mati o n)  
Dr y e ye Taste alterati o n ( d ys ge usia)  
Dr y m o ut h S ore t hr oat ( or o p har y n geal pai n)  
I n di gesti o n heart b ur n ( d ys pe psia)  
Li ver t o xicit y ( he pat ot o xicit y: i nj ur y of t he li ver d ue t o li ver cell da ma ge, i ncl u di n g li ver fail ure [t he latter is u nc o m m o n])  
I ncrease i n creati ni ne (a waste pr o d uct i n t he bl o o d) a n d a decrease i n t he ki d ne y's a bilit y t o ha n dle t he b o d y's waste ( bl o o d creati ni ne i ncrease d)  
C ha n ges i n t he electrical acti vit y of t he heart calle d Q Tc pr ol o n gati o n. T his is a n a b n or malit y of t he heart r h yt h m a n d ma y ca use dizzi ness, pal pitati o ns, fai nti n g, a n d i n se vere cases l oss of c o nsci o us ness a n d e ve n deat h Decrease d bl o o d calci u m le vels ( h y p ocalcae mia)  
Decrease d bl o o d p otassi u m le vels ( h y p o kale mia)  
P a g e 1 1 of 2 5 C C \# 1 4 5 5 1 5  
  
```
Decrease d bl o o d p h os p h or us le vels ( h y p o p h os p hate mia)

Re d ness of t he s ki n or re d de ni n g of t he s ki n (er yt he ma)

Dr y s ki n

L oss of s ki n c ol orati o n/ w hite ni n g, us uall y i n patc hes ( vitili g o)

Se nsati o n of l osi n g bala nce ( verti g o)

Rare b ut I m p orta nt ( m ay affect less t h a n 5 % of pe o ple ):


```  
P ote ntial acc u m ulati o n of ri b ocicli b i n t he t h yr oi d gla n d. I n rats, ri b ocicli b was f o u n d t o acc u m ulate i n t he t h yr oi d gla n d, b ut t here was n o e vi de nce of da ma ge t o t he t h yr oi d gla n d. T here ha ve bee n n o re p orts of a b n or mal t h yr oi d f u ncti o n i n a n y patie nt s o far.  
O ne patie nt partici pati n g i n a trial wit h ri b ocicli b a n d M E K 1 6 2 die d fr o m blee di n g i n t he brai n, w hic h was c o nsi dere d relate d t o ri b ocicli b a n d M E K 1 6 2 b y t he treati n g p h ysicia n.  
O ne patie nt partici pati n g i n a trial was dia g n ose d wit h ac ute l y m p h o blastic le u ke mia  
( A L L), w hic h t he treati n g p h ysicia n c o nsi dere d p ossi bl y relate d t o ri b ocicli b.  
O ne patie nt partici pati n g i n a trial was dia g n ose d wit h ac ute res pirat or y fail ure, w hic h was c o nsi dere d p ossi bl y relate d t o ri b ocicli b F o ur partici pa nt deat hs occ urre d o n a breast ca ncer st u d y, w hic h were c o nsi dere d t o be relate d t o ri b ocicli b. T w o deat hs were d ue t o ac ute res pirat or y fail ure, a n d t he ot her ca uses of deat h were p ne u m o nia a n d s u d de n deat h.  
O ne patie nt partici pati n g i n a trial wit h ri b ocicli b a n d letr oz ole was dia g n ose d wit h m yel o d ys plastic s y n dr o me, w hic h was c o nsi dere d p ossi bl y relate d t o ri b ocicli b.  
M yel o d ys plastic s y n dr o me ha p pe ns w he n t he b o ne marr o w, t he material i nsi de y o ur b o nes w here y o ur bl o o d cells are ma de, n o l o n ger w or ks n or mall y, w hic h ca n lea d t o feeli n g tire d, s h ort of breat h or ha vi n g s mall re d s p ots u n der y o ur s ki n ca use d b y blee di n g or i nfecti o ns.  
O n patie nt partici pati n g i n a trial wit h ri b ocicli b a n d letr oz ole e x perie nce d decrease d s o di u m le vels. Y o u ma y feel tire d, ha ve a hea dac he, feel na usea or v o mit, or ha ve cra m ps.  
O ne patie nt partici pati n g i n a trial wit h ri b ocicli b a n d letr oz ole was dia g n ose d wit h heart fail ure. Y o u mi g ht feel s h ort of breat h, wea k ness, s welli n g i n y o ur le gs, a n kles or feet, or a n irre g ular or ra pi d heart beat.  
Ris ks a n d si de effects relate d t o d ocet a xel a n d pre d nis o ne i ncl u de t h ose liste d bel o w:

Ri b ocicli b is a n i n vesti gati o nal dr u g a n d n ot all of t he si de effects are k n o w n. Seri o us si de effects, i ncl u di n g deat h, are a p ossi bilit y. T he l o n g-ter m effects of ri b ocicli b are als o u n k n o w n.  
Ris ks are p ossi ble si de effects of st u d y me dici ne gi ve n al o ne or i n c o m bi nati o n wit h ot her me dicati o n(s), a n d t h ose of ta ki n g bl o o d. Base d o n t he data fr o m o n g oi n g st u dies i n ca ncer patie nts, t he f oll o wi n g are t he p ossi ble ris ks wit h ta ki n g ri b ocicli b.  
Ver y c o m m o n si de effects m ay affect m ore t h a n 1 0 % of pe o ple  
L o w w hite bl o o d cell c o u nt w hic h i ncreases t he ris k of i nfecti o ns ( ne utr o pe nia or le u k o pe nia)  
I nfecti o ns (i ncl u di n g uri nar y tract i nfecti o ns, res pirat or y i nfecti o ns, gastr oe nteritis a n d se vere, p ote ntiall y life-t hreate ni n g i nfecti o ns [se psis; t his is u nc o m m o n])  
L o w re d bl o o d cell c o u nt w hic h ca n lea d t o tire d ness a n d wea k ness (a ne mia)  
```
Na usea

Diarr hea

V o miti n g

C o nsti pati o n

M o ut h s ores, or pai n, i nfla m mati o n a n d/ or i nfecti o n of t he m o ut h

A b d o mi nal pai n

Tire d ness or ge neralize d wea k ness (fati g ue or ast he nia)

S welli n g of t he ar ms or le gs ( peri p heral oe de ma)

Fe ver ( p yre xia)

I ncrease i n t he bl o o d le vels of li ver para meters as i n dicate d b y li ver tests (s uc h as

tra nsa mi nases a n d/ or bilir u bi n)

Decrease d a p petite

Bac k pai n

Hea dac he

Dizzi ness

S h ort ness of breat h ( d ys p nea)

C o u g h

Hair t hi n ni n g or l oss (al o pecia)

S ki n ras h

Itc hi n g of t he s ki n ( pr urit us)

C o m m o n si de effects m ay affect u p t o 1 0 % of pe o ple




```  
L o w platelet c o u nt w hic h ca n lea d t o eas y br uisi n g a n d blee di n g (t hr o m b oc yt o pe nia)  
L o w w hite bl o o d cell c o u nt wit h fe ver (fe brile ne utr o pe nia)  
L o w l y m p h oc yte c o u nt i n t he bl o o d t hat ca n pre dis p ose t o i nfecti o ns (l y m p h o pe nia)  
Fai nti n g e pis o des/tra nsie nt l oss of c o nsci o us ness a n d p ost ural p ost ure (s y nc o pe)  
E xcessi ve teari n g of t he e ye (i ncrease d lacri mati o n)  
Dr y e ye Taste alterati o n ( d ys ge usia)  
Dr y m o ut h S ore t hr oat ( or o p har y n geal pai n)  
I n di gesti o n heart b ur n ( d ys pe psia)  
Li ver t o xicit y ( he pat ot o xicit y: i nj ur y of t he li ver d ue t o li ver cell da ma ge, i ncl u di n g li ver fail ure [t he latter is u nc o m m o n])  
I ncrease i n creati ni ne (a waste pr o d uct i n t he bl o o d) a n d a decrease i n t he ki d ne y's a bilit y t o ha n dle t he b o d y's waste ( bl o o d creati ni ne i ncrease d)  
C ha n ges i n t he electrical acti vit y of t he heart calle d Q Tc pr ol o n gati o n. T his is a n a b n or malit y of t he heart r h yt h m a n d ma y ca use dizzi ness, pal pitati o ns, fai nti n g, a n d i n se vere cases l oss of c o nsci o us ness a n d e ve n deat h Decrease d bl o o d calci u m le vels ( h y p ocalcae mia)  
Decrease d bl o o d p otassi u m le vels ( h y p o kale mia)
P a g e 1 1 of 2 5 C C \# 1 4 5 5 1 5  
```
Decrease d bl o o d p h os p h or us le vels ( h y p o p h os p hate mia)

Re d ness of t he s ki n or re d de ni n g of t he s ki n (er yt he ma)

Dr y s ki n

L oss of s ki n c ol orati o n/ w hite ni n g, us uall y i n patc hes ( vitili g o)

Se nsati o n of l osi n g bala nce ( verti g o)

Rare b ut I m p orta nt ( m ay affect less t h a n 5 % of pe o ple ):




```  
P ote ntial acc u m ulati o n of ri b ocicli b i n t he t h yr oi d gla n d. I n rats, ri b ocicli b was f o u n d t o acc u m ulate i n t he t h yr oi d gla n d, b ut t here was n o e vi de nce of da ma ge t o t he t h yr oi d gla n d. T here ha ve bee n n o re p orts of a b n or mal t h yr oi d f u ncti o n i n a n y patie nt s o far.  
O ne patie nt partici pati n g i n a trial wit h ri b ocicli b a n d M E K 1 6 2 die d fr o m blee di n g i n t he brai n, w hic h was c o nsi dere d relate d t o ri b ocicli b a n d M E K 1 6 2 b y t he treati n g p h ysicia n.  
O ne patie nt partici pati n g i n a trial was dia g n ose d wit h ac ute l y m p h o blastic le u ke mia  
( A L L), w hic h t he treati n g p h ysicia n c o nsi dere d p ossi bl y relate d t o ri b ocicli b.  
O ne patie nt partici pati n g i n a trial was dia g n ose d wit h ac ute res pirat or y fail ure, w hic h was c o nsi dere d p ossi bl y relate d t o ri b ocicli b F o ur partici pa nt deat hs occ urre d o n a breast ca ncer st u d y, w hic h were c o nsi dere d t o be relate d t o ri b ocicli b. T w o deat hs were d ue t o ac ute res pirat or y fail ure, a n d t he ot her ca uses of deat h were p ne u m o nia a n d s u d de n deat h.  
O ne patie nt partici pati n g i n a trial wit h ri b ocicli b a n d letr oz ole was dia g n ose d wit h m yel o d ys plastic s y n dr o me, w hic h was c o nsi dere d p ossi bl y relate d t o ri b ocicli b.  
M yel o d ys plastic s y n dr o me ha p pe ns w he n t he b o ne marr o w, t he material i nsi de y o ur b o nes w here y o ur bl o o d cells are ma de, n o l o n ger w or ks n or mall y, w hic h ca n lea d t o feeli n g tire d, s h ort of breat h or ha vi n g s mall re d s p ots u n der y o ur s ki n ca use d b y blee di n g or i nfecti o ns.  
O n patie nt partici pati n g i n a trial wit h ri b ocicli b a n d letr oz ole e x perie nce d decrease d s o di u m le vels. Y o u ma y feel tire d, ha ve a hea dac he, feel na usea or v o mit, or ha ve cra m ps.  
O ne patie nt partici pati n g i n a trial wit h ri b ocicli b a n d letr oz ole was dia g n ose d wit h heart fail ure. Y o u mi g ht feel s h ort of breat h, wea k ness, s welli n g i n y o ur le gs, a n kles or feet, or a n irre g ular or ra pi d heart beat.  
Ris ks a n d si de effects relate d t o d ocet a xel a n d pre d nis o ne i ncl u de t h ose liste d bel o w:

Ras h Hair l oss Fl ui d rete nti o n/s welli n g Fati g ue U pset st o mac h S ore ness a n d/ or wea k ness of m uscles a n d/ or j oi nts P a g e 1 2 of 2 5 C C \# 1 4 5 5 1 5  
```
I ncrease d bl o o d s u gar le vels, w hic h ma y ca use i ncrease d t hirst, uri nati o n, a n d fati g ue

L o were d w hite bl o o d cell c o u nt t hat ma y lea d t o i ncrease d ris k of i nfecti o n

L o were d platelet c o u nt t hat ma y lea d t o i ncrease d br uisi n g or blee di n g

L o were d re d bl o o d cell c o u nt t hat ma y ca use tire d ness or s h ort ness of breat h (if t he c o u nt

gets t o o l o w y o u ma y nee d a tra nsf usi o n)

Less Li kel y


Diarr hea

Na usea a n d v o miti n g

M o ut h a n d t hr oat s ores

L oss of a p petite

L oss of refle xes

Dar ke ni n g or li g hte ni n g of fi n ger nail be ds

Peeli n g s ki n o n ha n ds a n d feet

I ns o m nia

N u m b ness a n d/ or ti n gli n g of t he fi n gers a n d t oes

Rare, b ut seri o us


```  
St o mac h ulcers a n d/ or blee di n g  
  
Se vere aller gic reacti o n (life-t hreate ni n g breat hi n g pr o ble ms)  
A b n or mal f u ncti o n of t he a dre nal gla n d w hic h ca n ca use wea k ness a n d fati g ue, l o w bl o o d press ure, na usea, v o miti n g, diarr hea, irrita bilit y a n d/ or restless ness, l oss of b o ne de nsit y L o w bl o o d press ure A b n or mal c ha n ges i n pers o nalit y I n a d diti o n, y o u s h o ul d ne ver st o p t he pre d nis o ne s u d de nl y. If y o u nee d t o st o p t he pre d nis o ne, y o ur d oct or will a d vise y o u o n h o w t o sl o wl y st o p t he dr u g (calle d a "ta per"). If y o u were t o st o p ta ki n g pre d nis o ne s u d de nl y, y o u c o ul d bec o me ver y wea k a n d tire d, de vel o p ver y l o w bl o o d press ure, ver y l o w bl o o d s u gar, a n d a b n or malities of t he mi nerals i n y o ur bl o o dstrea m. W hile us uall y n ot se vere, if n ot treate d, t hese a b n or malities are p ote ntiall y fatal. If y o u ha ve a seri o us ill ness, i nfecti o n, or tra u ma, it will be necessar y t o i ncrease y o ur d ose of pre d nis o ne. A n yti me y o u see a d oct or f or a n y reas o n, y o u s h o ul d tell hi m/ her t hat y o u are ta ki n g pre d nis o ne.  
We d o n ot k n o w t he si de effects of ri b ocicli b, d oceta xel, a n d pre d nis o ne w he n gi ve n al o ne or i n c o m bi nati o n wit h ot her dr u gs. A c o m bi nati o n of dr u gs mi g ht res ult i n seri o us or e ve n lifet hreate ni n g si de effects. S o me o ver-t he-c o u nter a n d prescri pti o n me dicati o ns ca n re d uce t he effecti ve ness or i ncrease t he si de effects of t he st u d y treat me nts. Li ke wise, t he st u d y treat me nts ca n i ncrease t he si de effects or lesse n t he effecti ve ness of s o me me dicati o ns. T his mi g ht res ult i n seri o us or e ve n life-t hreate ni n g si de effects. Y o u s h o ul d al wa ys disc uss t he use of a n y dr u gs  
( o ver-t he-c o u nter dr u gs, prescri pti o n, or ille gal dr u gs or healt h f o o d s u p ple me nts) wit h y o ur d oct or w hile y o u are partici pati n g i n t his st u d y. T he st u d y pr ot oc ol descri bes w hic h me dici nes are pr o hi bite d d uri n g t he st u d y, a n d w hic h o nes ca n be ta ke n wit h ca uti o n.  
I R B N U M B E R: 1 5- 1 5 7 4 5 I R B A P P R O V A L D A T E: 0 7/ 2 6/ 2 0 1 9 I R B E X PI R A TI O N D A T E: 0 2/ 1 1/ 2 0 2 0  
  
T here c o ul d be a d diti o nal u ne x pecte d si de effects w he n ri b ocicli b is ta ke n i n c o m bi nati o n wit h d oceta xel a n d pre d nis o ne.

Ras h Hair l oss Fl ui d rete nti o n/s welli n g Fati g ue U pset st o mac h S ore ness a n d/ or wea k ness of m uscles a n d/ or j oi nts P a g e 1 2 of 2 5 C C \# 1 4 5 5 1 5  
```
I ncrease d bl o o d s u gar le vels, w hic h ma y ca use i ncrease d t hirst, uri nati o n, a n d fati g ue

L o were d w hite bl o o d cell c o u nt t hat ma y lea d t o i ncrease d ris k of i nfecti o n

L o were d platelet c o u nt t hat ma y lea d t o i ncrease d br uisi n g or blee di n g

L o were d re d bl o o d cell c o u nt t hat ma y ca use tire d ness or s h ort ness of breat h (if t he c o u nt

gets t o o l o w y o u ma y nee d a tra nsf usi o n)

Less Li kel y




Diarr hea

Na usea a n d v o miti n g

M o ut h a n d t hr oat s ores

L oss of a p petite

L oss of refle xes

Dar ke ni n g or li g hte ni n g of fi n ger nail be ds

Peeli n g s ki n o n ha n ds a n d feet

I ns o m nia

N u m b ness a n d/ or ti n gli n g of t he fi n gers a n d t oes

Rare, b ut seri o us


```  
St o mac h ulcers a n d/ or blee di n g Se vere aller gic reacti o n (life-t hreate ni n g breat hi n g pr o ble ms)  
A b n or mal f u ncti o n of t he a dre nal gla n d w hic h ca n ca use wea k ness a n d fati g ue, l o w bl o o d press ure, na usea, v o miti n g, diarr hea, irrita bilit y a n d/ or restless ness, l oss of b o ne de nsit y L o w bl o o d press ure A b n or mal c ha n ges i n pers o nalit y I n a d diti o n, y o u s h o ul d ne ver st o p t he pre d nis o ne s u d de nl y. If y o u nee d t o st o p t he pre d nis o ne, y o ur d oct or will a d vise y o u o n h o w t o sl o wl y st o p t he dr u g (calle d a "ta per"). If y o u were t o st o p ta ki n g pre d nis o ne s u d de nl y, y o u c o ul d bec o me ver y wea k a n d tire d, de vel o p ver y l o w bl o o d press ure, ver y l o w bl o o d s u gar, a n d a b n or malities of t he mi nerals i n y o ur bl o o dstrea m. W hile us uall y n ot se vere, if n ot treate d, t hese a b n or malities are p ote ntiall y fatal. If y o u ha ve a seri o us ill ness, i nfecti o n, or tra u ma, it will be necessar y t o i ncrease y o ur d ose of pre d nis o ne. A n yti me y o u see a d oct or f or a n y reas o n, y o u s h o ul d tell hi m/ her t hat y o u are ta ki n g pre d nis o ne.  
We d o n ot k n o w t he si de effects of ri b ocicli b, d oceta xel, a n d pre d nis o ne w he n gi ve n al o ne or i n c o m bi nati o n wit h ot her dr u gs. A c o m bi nati o n of dr u gs mi g ht res ult i n seri o us or e ve n lifet hreate ni n g si de effects. S o me o ver-t he-c o u nter a n d prescri pti o n me dicati o ns ca n re d uce t he effecti ve ness or i ncrease t he si de effects of t he st u d y treat me nts. Li ke wise, t he st u d y treat me nts ca n i ncrease t he si de effects or lesse n t he effecti ve ness of s o me me dicati o ns. T his mi g ht res ult i n seri o us or e ve n life-t hreate ni n g si de effects. Y o u s h o ul d al wa ys disc uss t he use of a n y dr u gs  
( o ver-t he-c o u nter dr u gs, prescri pti o n, or ille gal dr u gs or healt h f o o d s u p ple me nts) wit h y o ur d oct or w hile y o u are partici pati n g i n t his st u d y. T he st u d y pr ot oc ol descri bes w hic h me dici nes are pr o hi bite d d uri n g t he st u d y, a n d w hic h o nes ca n be ta ke n wit h ca uti o n. T here c o ul d be a d diti o nal u ne x pecte d si de effects w he n ri b ocicli b is ta ke n i n c o m bi nati o n wit h  
  
d oceta xel a n d pre d nis o ne.

G- C S F ca uses b o ne pai n i n ma n y pe o ple. T his pai n ma y occ ur i m me diatel y or se veral da ys after recei vi n g G- C S F. T he pai n ma y feel li ke a n ac hi n g se nsati o n i n t he b o nes of t he bac k, hi ps, pel vis, or breast b o ne. Pai n relie vers, s uc h as aceta mi n o p he n ( T yle n ol ®) or i b u pr ofe n ( A d vil ®,  
N u pri n ®) ma y be use d t o lesse n t his disc o mf ort.  
Occasi o nall y, G- C S F ma y ca use fl u-li ke s y m pt o ms. If y o u alrea d y ha ve i nfla m mati o n of certai n bl o o d vessels, art hritis, ecze ma or ps oriasis, G- C S F ma y ca use t hese c o n diti o ns t o get w orse.  
Ot her occasi o nal si de effects i ncl u de hea dac hes, m uscle ac hes, tire d ness, na usea a n d v o miti n g, a n d tr o u ble slee pi n g. T hese s y m pt o ms us uall y g o a wa y wit hi n 2 or 3 da ys after st o p pi n g G- C S F.  
T he f oll o wi n g si de effects are rare a n d are n ot ge nerall y seri o us pr o ble ms:  
B ur ni n g, s welli n g, a n d re d ness at t he i njecti o n site Aller gic reacti o ns ( hi ves/s ki n ras h, itc hi n g, w heezi n g, fe ver, ra pi d heart rate, s h ort ness of breat h, dizzi ness)  
L o weri n g of bl o o d press ure C ha n ges i n bl o o d c he mistr y le vels E nlar ge me nt of t he s plee n (see n i n s o me patie nts treate d wit h G- C S F f or a n e xte n de d peri o d of ti me)  
Rare b ut seri o us:  
Se vere reacti o ns t o G- C S F i n patie nts wit h sic kle cell a ne mia a n d relate d sic kle cell diseases.  
Pai n a n d blee di n g fr o m t he s plee n, w hic h ma y re q uire s ur ger y. If y o u feel pai n i n y o ur u p per left si de j ust bel o w t he ri b ca ge, c o ntact y o ur d oct or i m me diatel y.

G- C S F ca uses b o ne pai n i n ma n y pe o ple. T his pai n ma y occ ur i m me diatel y or se veral da ys after recei vi n g G- C S F. T he pai n ma y feel li ke a n ac hi n g se nsati o n i n t he b o nes of t he bac k, hi ps, pel vis, or breast b o ne. Pai n relie vers, s uc h as aceta mi n o p he n ( T yle n ol ®) or i b u pr ofe n ( A d vil ®,  
N u pri n ®) ma y be use d t o lesse n t his disc o mf ort.  
Occasi o nall y, G- C S F ma y ca use fl u-li ke s y m pt o ms. If y o u alrea d y ha ve i nfla m mati o n of certai n bl o o d vessels, art hritis, ecze ma or ps oriasis, G- C S F ma y ca use t hese c o n diti o ns t o get w orse.  
Ot her occasi o nal si de effects i ncl u de hea dac hes, m uscle ac hes, tire d ness, na usea a n d v o miti n g, a n d tr o u ble slee pi n g. T hese s y m pt o ms us uall y g o a wa y wit hi n 2 or 3 da ys after st o p pi n g G- C S F.  
T he f oll o wi n g si de effects are rare a n d are n ot ge nerall y seri o us pr o ble ms:  
B ur ni n g, s welli n g, a n d re d ness at t he i njecti o n site Aller gic reacti o ns ( hi ves/s ki n ras h, itc hi n g, w heezi n g, fe ver, ra pi d heart rate, s h ort ness of breat h, dizzi ness)  
L o weri n g of bl o o d press ure C ha n ges i n bl o o d c he mistr y le vels E nlar ge me nt of t he s plee n (see n i n s o me patie nts treate d wit h G- C S F f or a n e xte n de d peri o d of ti me)  
Rare b ut seri o us:  
Se vere reacti o ns t o G- C S F i n patie nts wit h sic kle cell a ne mia a n d relate d sic kle cell diseases.  
Pai n a n d blee di n g fr o m t he s plee n, w hic h ma y re q uire s ur ger y. If y o u feel pai n i n y o ur u p per left si de j ust bel o w t he ri b ca ge, c o ntact y o ur d oct or i m me diatel y.

Bl o o d dr a wi n g ( ve ni p u nct ure) ris ks: Dra wi n g bl o o d ma y ca use te m p orar y disc o mf ort fr o m t he nee dle stic k, br uisi n g, a n d i nfecti o n. I n rare i nsta nces w here a n urse, a d oct or, or a la b orat or y tec h nicia n s ustai ns a n e x p os ure t o y o ur bl o o d, tiss ue or b o d y fl ui ds b y nee dle stic k, c ut or s plas h t o m uc osa or da ma ge d s ki n, it ma y be necessar y t o test y o ur bl o o d, tiss ue, or b o d y fl ui d sa m ple f or certai n viral i nfecti o ns i ncl u di n g He patitis B a n d C a n d HI V o n t he sa m ple alrea d y a vaila ble.  
T his is t o e na ble t hat pers o n t o recei ve a p pr o priate c o u nseli n g, m o nit ori n g, a n d treat me nt if necessar y. I n t his i nsta nce, t he St u d y D oct or will offer y o u t he i nf or mati o n rele va nt t o y o ur healt h a n d a d vise y o u o n t he ne xt ste ps. C o nfi de ntialit y of y o ur data will be res pecte d at all ti mes.  
  
C T sc a n ris ks: C T sca ns i n v ol ve t he ris ks of ra diati o n. I n a d diti o n, if c o ntrast material (i o di ne d ye) is use d, t here is a sli g ht ris k of de vel o pi n g a n aller gic reacti o n. T he aller gic reacti o n ca n be mil d (itc hi n g, ras h) t o se vere ( diffic ult y breat hi n g, s h oc k, or rarel y, deat h). T he c o ntrast material ma y als o ca use ki d ne y pr o ble ms, es peciall y if y o u are de h y drate d or ha ve p o or ki d ne y f u ncti o n.  
T he st u d y d oct ors will as k y o u a b o ut a n y aller gies or relate d c o n diti o ns y o u ma y ha ve bef ore t he pr oce d ure is d o ne. If y o u ha ve a n y of t hese aller gies or c o n diti o ns, y o u ma y n ot be all o we d t o  
```
ha ve a C T sca n i n t he st u d y.

Ha vi n g a C T sca n ma y mea n s o me a d de d disc o mf ort f or y o u. I n partic ular, y o u ma y be b ot here d

b y feeli n gs of cla ustr o p h o bia w he n place d i nsi de t he C T sca n ner, or b y l yi n g i n a still p ositi o n

f or a l o n g ti me. If c o ntrast material is use d, y o u ma y feel disc o mf ort w he n it is i njecte d i nt o y o ur

b o d y. Y o u ma y feel war m a n d fl us he d a n d/ or get a metallic taste i n y o ur m o ut h. Rarel y, t he

c o ntrast material ma y ca use na usea, v o miti n g or a hea dac he.

M RI ris ks : Beca use t he M RI mac hi ne acts li ke a lar ge ma g net, it c o ul d m o ve ir o n-c o ntai ni n g

o bjects i n t he M RI r o o m d uri n g y o ur e xa mi nati o n, w hic h i n t he pr ocess c o ul d p ossi bl y har m

y o u. Preca uti o ns ha ve bee n ta ke n t o pre ve nt s uc h a n e ve nt fr o m ha p pe ni n g; l o ose metal o bjects,

li ke p oc ket k ni ves or ke y c hai ns, are n ot all o we d i n t he M RI r o o m. If y o u ha ve a piece of metal

i n y o ur b o d y, s uc h as a fra g me nt i n y o ur e ye, a ne ur ys m cli ps, ear i m pla nts, s pi nal ner ve

sti m ulat ors, or a pace ma ker, y o u will n ot be all o we d i nt o t he M RI r o o m a n d ca n n ot ha ve a n

M RI.

Ha vi n g a n M RI ma y mea n s o me a d de d disc o mf ort f or y o u. I n partic ular, y o u ma y be b ot here d b y

feeli n gs of cla ustr o p h o bia a n d b y t he l o u d ba n gi n g n oise d uri n g t he st u d y. Te m p orar y heari n g

l oss has bee n re p orte d fr o m t his l o u d n oise. T his is w h y y o u will be as ke d t o wear ear pl u gs. At

ti mes d uri n g t he test, y o u ma y be as ke d t o n ot s wall o w f or a w hile, w hic h ca n feel

u nc o mf orta ble.

C o ntr ast a ge nt ( g a d oli ni u m) ris ks : A fe w si de effects of ga d oli ni u m i njecti o n s uc h as

mil d hea dac he, na usea, a n d l ocal pai n ma y occ ur. Rarel y, (less t ha n 1 % of t he ti me) l o w

bl o o d press ure a n d li g ht hea de d ness ma y occ ur. T his ca n be treate d i m me diatel y wit h

fl ui ds gi ve n t hr o u g h o ne of y o ur vei ns. Ver y rarel y, (less t ha n o ne i n o ne t h o usa n d),

patie nts are aller gic t o ga d oli ni u m. T hese aller gic effects m ost c o m m o nl y i ncl u de hi ves

a n d itc h y e yes, b ut m ore se vere reacti o ns, i ncl u di n g s h ort ness of breat h, ha ve bee n see n.

Patie nts wit h se vere ki d ne y disease s o meti mes ha ve a ba d reacti o n t o t he ga d oli ni u m

c o ntrast material. T his c o n diti o n is calle d ne p hr o ge nic s yste mic fi br osis ( N S F). It ca n

ca use s ki n t o ti g hte n or scar a n d ca n da ma ge i nter nal or ga ns. S o meti mes it ca n be lifet hreate ni n g. T here are n o re p orts of N S F i n patie nts wit h n or mal ki d ne y f u ncti o n.

Bef ore y o u ha ve a n M RI sca n re q uiri n g a n i njecti o n of ga d oli ni u m c o ntrast, y o u will

nee d t o ha ve a bl o o d test i n or der t o c hec k t he f u ncti o n of y o ur ki d ne ys. Base d o n y o ur

me dical hist or y a n d t he res ults of t his test, a d oct or will deci de w het her it is safe f or y o u

t o u n der g o t he M RI sca ns.


```  
  
B o ne sc a n ris k : A b o ne sca n i n v ol ves e x p os ure t o ra diati o n. ( See Ra diati o n Ris ks bel o w). S o me pe o ple ma y ha ve a cl ose d-i n feeli n g w hile u n der t he ca mera. As i n a n y i njecti o n, y o u ma y ha ve s welli n g or br uisi n g at t he i njecti o n site.  
R a di ati o n ris ks: T his researc h st u d y i n v ol ves e x p os ure t o ra diati o n. N ot all t his ra diati o n e x p os ure is necessar y f or y o ur me dical care a n d is f or researc h p ur p oses o nl y. T his a m o u nt of ra diati o n ma y i n v ol ve a l o w ris k of ca ncer. H o we ver, we belie ve t hat t his ris k, gi ve n y o ur o verall me dical c o n diti o n is n ot cli nicall y rele va nt. If y o u ha ve a n y q uesti o ns re gar di n g t he use of ra diati o n or t he ris ks i n v ol ve d, please c o ns ult t he p h ysicia n c o n d ucti n g t he st u d y.  
Electr oc ar di o gr a m ( E K G/ E C G) ris ks: T he E C G i n v ol ves placi n g electr o des o n t he s ki n. Y o u ma y e x perie nce a n aller gic reacti o n t o t he a d hesi ve use d t o attac h t he electr o des t o t he s ki n.  
T hese s y m pt o ms are ge nerall y mil d a n d clear u p o n t heir o w n. Please let y o ur d oct or k n o w if y o u are a ware of a n y aller gies.  
Ec h oc ar di o gr a m ( E C H O): T he car diac ec h o gra m mi g ht ca use y o u t o be u nc o mf orta ble fr o m t he press ure of t he pr o be o n y o ur c hest or l yi n g still f or t he e xa mi nati o n.  
M U G A sc a n ris ks : M U G A sca ns i n v ol ve t he ris ks of ra diati o n ( See Ra diati o n Ris ks a b o ve).  
Y o u ma y de vel o p br uisi n g w here t he nee dle is place d i n y o ur vei ns t o a d mi nister t he ra di oacti ve s u bsta nce. Y o u ma y be u nc o mf orta ble l yi n g flat.  
S afe H a n dli n g of Me dic ati o ns: Ha n dli n g ri b ocicli b a n d ha vi n g c o ntact wit h a n y uri ne, feces, or v o mit fr o m patie nts recei vi n g ri b ocicli b ma y p ose s o me ris k t o y o u a n d y o ur care gi vers. T o a v oi d e x p os ure t o ri b ocicli b a n d a n y ass ociate d ris ks, y o u a n d y o ur fa mil y me m bers/care gi vers will be e d ucate d b y a me m ber of t he st u d y tea m o n h o w t o safel y ha n dle, pr o perl y dis p ose of, a n d clea n pr o d ucts t hat ma y be c o nta mi nate d wit h ri b ocicli b.  
D ose Esc al ati o n Ris ks: Si nce patie nts will be assi g ne d t o differe nt d oses of st u d y dr u g, s o me patie nts ma y recei ve a d ose of t he dr u g t hat is t o o s mall t o be effecti ve w hile ot hers ma y recei ve a hi g her d ose t hat ma y ca use i ncrease d si de effects. Y o u ca n as k y o ur st u d y d oct or w hat d ose y o u will be gi ve n.  
Re pr o d ucti ve Ris ks: Y o u s h o ul d n ot fat her a ba b y w hile o n t his st u d y beca use t he dr u gs i n t his st u d y ca n affect a n u n b or n ba b y. It is i m p orta nt t o u n dersta n d t hat y o u nee d t o use birt h c o ntr ol w hile o n t his st u d y. Y o u m ust al wa ys wear a c o n d o m d uri n g i nterc o urse (e ve n if y o u ha ve ha d a vasect o m y), a n d if fertile y o u m ust als o use s per mici de. Y o u m ust c o nti n ue t o wear a c o n d o m w hile ta ki n g t he dr u g a n d f or 3 0 da ys after st o p pi n g treat me nt. F or m ore i nf or mati o n re gar di n g c o ntrace pti o n please s pea k t o y o ur st u d y d oct or.  
U n k n o w n Ris ks: T he e x peri me ntal treat me nts ma y ha ve si de effects t hat n o o ne k n o ws a b o ut.  
T he researc hers will let y o u k n o w if t he y lear n a n yt hi n g t hat mi g ht ma ke y o u c ha n ge y o ur mi n d a b o ut partici pati n g i n t he st u d y.  
F or m ore i nf or mati o n a b o ut ris ks a n d si de effects, as k y o ur st u d y d oct or.

Bl o o d dr a wi n g ( ve ni p u nct ure) ris ks: Dra wi n g bl o o d ma y ca use te m p orar y disc o mf ort fr o m t he nee dle stic k, br uisi n g, a n d i nfecti o n. I n rare i nsta nces w here a n urse, a d oct or, or a la b orat or y tec h nicia n s ustai ns a n e x p os ure t o y o ur bl o o d, tiss ue or b o d y fl ui ds b y nee dle stic k, c ut or s plas h t o m uc osa or da ma ge d s ki n, it ma y be necessar y t o test y o ur bl o o d, tiss ue, or b o d y fl ui d sa m ple f or certai n viral i nfecti o ns i ncl u di n g He patitis B a n d C a n d HI V o n t he sa m ple alrea d y a vaila ble.  
T his is t o e na ble t hat pers o n t o recei ve a p pr o priate c o u nseli n g, m o nit ori n g, a n d treat me nt if necessar y. I n t his i nsta nce, t he St u d y D oct or will offer y o u t he i nf or mati o n rele va nt t o y o ur healt h a n d a d vise y o u o n t he ne xt ste ps. C o nfi de ntialit y of y o ur data will be res pecte d at all ti mes. C T sc a n ris ks: C T sca ns i n v ol ve t he ris ks of ra diati o n. I n a d diti o n, if c o ntrast material (i o di ne  
  
d ye) is use d, t here is a sli g ht ris k of de vel o pi n g a n aller gic reacti o n. T he aller gic reacti o n ca n be mil d (itc hi n g, ras h) t o se vere ( diffic ult y breat hi n g, s h oc k, or rarel y, deat h). T he c o ntrast material ma y als o ca use ki d ne y pr o ble ms, es peciall y if y o u are de h y drate d or ha ve p o or ki d ne y f u ncti o n.  
T he st u d y d oct ors will as k y o u a b o ut a n y aller gies or relate d c o n diti o ns y o u ma y ha ve bef ore t he pr oce d ure is d o ne. If y o u ha ve a n y of t hese aller gies or c o n diti o ns, y o u ma y n ot be all o we d t o  
```
ha ve a C T sca n i n t he st u d y.

Ha vi n g a C T sca n ma y mea n s o me a d de d disc o mf ort f or y o u. I n partic ular, y o u ma y be b ot here d

b y feeli n gs of cla ustr o p h o bia w he n place d i nsi de t he C T sca n ner, or b y l yi n g i n a still p ositi o n

f or a l o n g ti me. If c o ntrast material is use d, y o u ma y feel disc o mf ort w he n it is i njecte d i nt o y o ur

b o d y. Y o u ma y feel war m a n d fl us he d a n d/ or get a metallic taste i n y o ur m o ut h. Rarel y, t he

c o ntrast material ma y ca use na usea, v o miti n g or a hea dac he.

M RI ris ks : Beca use t he M RI mac hi ne acts li ke a lar ge ma g net, it c o ul d m o ve ir o n-c o ntai ni n g

o bjects i n t he M RI r o o m d uri n g y o ur e xa mi nati o n, w hic h i n t he pr ocess c o ul d p ossi bl y har m

y o u. Preca uti o ns ha ve bee n ta ke n t o pre ve nt s uc h a n e ve nt fr o m ha p pe ni n g; l o ose metal o bjects,

li ke p oc ket k ni ves or ke y c hai ns, are n ot all o we d i n t he M RI r o o m. If y o u ha ve a piece of metal

i n y o ur b o d y, s uc h as a fra g me nt i n y o ur e ye, a ne ur ys m cli ps, ear i m pla nts, s pi nal ner ve

sti m ulat ors, or a pace ma ker, y o u will n ot be all o we d i nt o t he M RI r o o m a n d ca n n ot ha ve a n

M RI.

Ha vi n g a n M RI ma y mea n s o me a d de d disc o mf ort f or y o u. I n partic ular, y o u ma y be b ot here d b y

feeli n gs of cla ustr o p h o bia a n d b y t he l o u d ba n gi n g n oise d uri n g t he st u d y. Te m p orar y heari n g

l oss has bee n re p orte d fr o m t his l o u d n oise. T his is w h y y o u will be as ke d t o wear ear pl u gs. At

ti mes d uri n g t he test, y o u ma y be as ke d t o n ot s wall o w f or a w hile, w hic h ca n feel

u nc o mf orta ble.

C o ntr ast a ge nt ( g a d oli ni u m) ris ks : A fe w si de effects of ga d oli ni u m i njecti o n s uc h as

mil d hea dac he, na usea, a n d l ocal pai n ma y occ ur. Rarel y, (less t ha n 1 % of t he ti me) l o w

bl o o d press ure a n d li g ht hea de d ness ma y occ ur. T his ca n be treate d i m me diatel y wit h

fl ui ds gi ve n t hr o u g h o ne of y o ur vei ns. Ver y rarel y, (less t ha n o ne i n o ne t h o usa n d),

patie nts are aller gic t o ga d oli ni u m. T hese aller gic effects m ost c o m m o nl y i ncl u de hi ves

a n d itc h y e yes, b ut m ore se vere reacti o ns, i ncl u di n g s h ort ness of breat h, ha ve bee n see n.

Patie nts wit h se vere ki d ne y disease s o meti mes ha ve a ba d reacti o n t o t he ga d oli ni u m

c o ntrast material. T his c o n diti o n is calle d ne p hr o ge nic s yste mic fi br osis ( N S F). It ca n

ca use s ki n t o ti g hte n or scar a n d ca n da ma ge i nter nal or ga ns. S o meti mes it ca n be lifet hreate ni n g. T here are n o re p orts of N S F i n patie nts wit h n or mal ki d ne y f u ncti o n.

Bef ore y o u ha ve a n M RI sca n re q uiri n g a n i njecti o n of ga d oli ni u m c o ntrast, y o u will

nee d t o ha ve a bl o o d test i n or der t o c hec k t he f u ncti o n of y o ur ki d ne ys. Base d o n y o ur

me dical hist or y a n d t he res ults of t his test, a d oct or will deci de w het her it is safe f or y o u

t o u n der g o t he M RI sca ns.

```  
B o ne sc a n ris k : A b o ne sca n i n v ol ves e x p os ure t o ra diati o n. ( See Ra diati o n Ris ks bel o w). S o me  
  
pe o ple ma y ha ve a cl ose d-i n feeli n g w hile u n der t he ca mera. As i n a n y i njecti o n, y o u ma y ha ve s welli n g or br uisi n g at t he i njecti o n site.  
R a di ati o n ris ks: T his researc h st u d y i n v ol ves e x p os ure t o ra diati o n. N ot all t his ra diati o n e x p os ure is necessar y f or y o ur me dical care a n d is f or researc h p ur p oses o nl y. T his a m o u nt of ra diati o n ma y i n v ol ve a l o w ris k of ca ncer. H o we ver, we belie ve t hat t his ris k, gi ve n y o ur o verall me dical c o n diti o n is n ot cli nicall y rele va nt. If y o u ha ve a n y q uesti o ns re gar di n g t he use of ra diati o n or t he ris ks i n v ol ve d, please c o ns ult t he p h ysicia n c o n d ucti n g t he st u d y.  
Electr oc ar di o gr a m ( E K G/ E C G) ris ks: T he E C G i n v ol ves placi n g electr o des o n t he s ki n. Y o u ma y e x perie nce a n aller gic reacti o n t o t he a d hesi ve use d t o attac h t he electr o des t o t he s ki n.  
T hese s y m pt o ms are ge nerall y mil d a n d clear u p o n t heir o w n. Please let y o ur d oct or k n o w if y o u are a ware of a n y aller gies.  
Ec h oc ar di o gr a m ( E C H O): T he car diac ec h o gra m mi g ht ca use y o u t o be u nc o mf orta ble fr o m t he press ure of t he pr o be o n y o ur c hest or l yi n g still f or t he e xa mi nati o n.  
M U G A sc a n ris ks : M U G A sca ns i n v ol ve t he ris ks of ra diati o n ( See Ra diati o n Ris ks a b o ve).  
Y o u ma y de vel o p br uisi n g w here t he nee dle is place d i n y o ur vei ns t o a d mi nister t he ra di oacti ve s u bsta nce. Y o u ma y be u nc o mf orta ble l yi n g flat.  
S afe H a n dli n g of Me dic ati o ns: Ha n dli n g ri b ocicli b a n d ha vi n g c o ntact wit h a n y uri ne, feces, or v o mit fr o m patie nts recei vi n g ri b ocicli b ma y p ose s o me ris k t o y o u a n d y o ur care gi vers. T o a v oi d e x p os ure t o ri b ocicli b a n d a n y ass ociate d ris ks, y o u a n d y o ur fa mil y me m bers/care gi vers will be e d ucate d b y a me m ber of t he st u d y tea m o n h o w t o safel y ha n dle, pr o perl y dis p ose of, a n d clea n pr o d ucts t hat ma y be c o nta mi nate d wit h ri b ocicli b.  
D ose Esc al ati o n Ris ks: Si nce patie nts will be assi g ne d t o differe nt d oses of st u d y dr u g, s o me patie nts ma y recei ve a d ose of t he dr u g t hat is t o o s mall t o be effecti ve w hile ot hers ma y recei ve a hi g her d ose t hat ma y ca use i ncrease d si de effects. Y o u ca n as k y o ur st u d y d oct or w hat d ose y o u will be gi ve n.  
Re pr o d ucti ve Ris ks: Y o u s h o ul d n ot fat her a ba b y w hile o n t his st u d y beca use t he dr u gs i n t his st u d y ca n affect a n u n b or n ba b y. It is i m p orta nt t o u n dersta n d t hat y o u nee d t o use birt h c o ntr ol w hile o n t his st u d y. Y o u m ust al wa ys wear a c o n d o m d uri n g i nterc o urse (e ve n if y o u ha ve ha d a vasect o m y), a n d if fertile y o u m ust als o use s per mici de. Y o u m ust c o nti n ue t o wear a c o n d o m w hile ta ki n g t he dr u g a n d f or 3 0 da ys after st o p pi n g treat me nt. F or m ore i nf or mati o n re gar di n g c o ntrace pti o n please s pea k t o y o ur st u d y d oct or.  
U n k n o w n Ris ks: T he e x peri me ntal treat me nts ma y ha ve si de effects t hat n o o ne k n o ws a b o ut.  
T he researc hers will let y o u k n o w if t he y lear n a n yt hi n g t hat mi g ht ma ke y o u c ha n ge y o ur mi n d a b o ut partici pati n g i n t he st u d y.  
F or m ore i nf or mati o n a b o ut ris ks a n d si de effects, as k y o ur st u d y d oct or.

Ta ki n g part i n t his st u d y ma y or ma y n ot ma ke y o ur healt h better. W hile d oct ors h o pe t hat t he c o m bi nati o n of ri b ocicli b wit h d oceta xel pl us pre d nis o ne will be m ore usef ul a gai nst ca ncer c o m pare d t o t he us ual treat me nt, t here is n o pr o of of t his. Y o ur c o n diti o n ma y e ve n get w orse d uri n g t he st u d y. We d o k n o w t hat t he i nf or mati o n fr o m t his st u d y will hel p d oct ors lear n m ore a b o ut t heses st u d y dr u g c o m bi nati o ns as a treat me nt f or ca ncer. T his i nf or mati o n c o ul d hel p f ut ure ca ncer patie nts. H o we ver, t here is n o g uara ntee t hat t his will ha p pe n.

Ta ki n g part i n t his st u d y ma y or ma y n ot ma ke y o ur healt h better. W hile d oct ors h o pe t hat t he c o m bi nati o n of ri b ocicli b wit h d oceta xel pl us pre d nis o ne will be m ore usef ul a gai nst ca ncer c o m pare d t o t he us ual treat me nt, t here is n o pr o of of t his. Y o ur c o n diti o n ma y e ve n get w orse d uri n g t he st u d y. We d o k n o w t hat t he i nf or mati o n fr o m t his st u d y will hel p d oct ors lear n m ore a b o ut t heses st u d y dr u g c o m bi nati o ns as a treat me nt f or ca ncer. T his i nf or mati o n c o ul d hel p f ut ure ca ncer patie nts. H o we ver, t here is n o g uara ntee t hat t his will ha p pe n.

It is i m p orta nt t hat y o u tell y o ur st u d y d oct or, Ra h ul A g gar wal, M. D., if y o u feel t hat y o u ha ve bee n i nj ure d beca use of ta ki n g part i n t his st u d y. Y o u ca n tell t he d oct or i n pers o n or call Tre at me nt a n d C o m pe ns ati o n f or I nj ur y: If y o u are i nj ure d as a res ult of bei n g i n t his st u d y, t he U ni versit y of Calif or nia will pr o vi de necessar y me dical treat me nt. T he c osts of t he treat me nt ma y be bille d t o y o u or y o ur i ns urer j ust li ke a n y ot her me dical c osts, or c o vere d b y t he U ni versit y of Calif or nia, de pe n di n g o n a n u m ber of fact ors. T he U ni versit y a n d t he st u d y s p o ns or d o n ot n or mall y pr o vi de a n y ot her f or m of c o m pe nsati o n f or i nj ur y. F or f urt her i nf or mati o n a b o ut t his, y o u ma y call t he office of t he C o m mittee o n H u ma n Researc h at 4 1 5- 4 7 6- 1 8 1 4.

It is i m p orta nt t hat y o u tell y o ur st u d y d oct or, Ra h ul A g gar wal, M. D., if y o u feel t hat y o u ha ve bee n i nj ure d beca use of ta ki n g part i n t his st u d y. Y o u ca n tell t he d oct or i n pers o n or call Tre at me nt a n d C o m pe ns ati o n f or I nj ur y: If y o u are i nj ure d as a res ult of bei n g i n t his st u d y, t he U ni versit y of Calif or nia will pr o vi de necessar y me dical treat me nt. T he c osts of t he treat me nt ma y be bille d t o y o u or y o ur i ns urer j ust li ke a n y ot her me dical c osts, or c o vere d b y t he U ni versit y of Calif or nia, de pe n di n g o n a n u m ber of fact ors. T he U ni versit y a n d t he st u d y s p o ns or d o n ot n or mall y pr o vi de a n y ot her f or m of c o m pe nsati o n f or i nj ur y. F or f urt her i nf or mati o n a b o ut t his, y o u ma y call t he office of t he C o m mittee o n H u ma n Researc h at 4 1 5- 4 7 6- 1 8 1 4.

T he researc h t hat ma y be d o ne wit h y o ur bl o o d sa m ple is n ot desi g ne d s pecificall y t o hel p y o u. It mi g ht hel p pe o ple w h o ha ve ca ncer a n d ot her diseases i n t he f ut ure. T he be nefits of researc h usi n g bl o o d sa m ple i ncl u de lear ni n g m ore a b o ut w hat ca uses ca ncer a n d ot her diseases, h o w t o pre ve nt t he m, a n d h o w t o treat t he m.  
U C S F will be t he e xcl usi ve o w ner of a n y data a n d disc o veries res ulti n g fr o m t his researc h.  
A n y c o m mercial pr o d uct de vel o pe d at U C S F as a res ult of t hese st u dies w o ul d be fr o m t he a nal ysis of all sa m ples c ollecte d i n t his st u d y, n ot fr o m a n i n di vi d ual s u bject's sa m ple.

T he researc h t hat ma y be d o ne wit h y o ur bl o o d sa m ple is n ot desi g ne d s pecificall y t o hel p y o u. It mi g ht hel p pe o ple w h o ha ve ca ncer a n d ot her diseases i n t he f ut ure. T he be nefits of researc h usi n g bl o o d sa m ple i ncl u de lear ni n g m ore a b o ut w hat ca uses ca ncer a n d ot her diseases, h o w t o pre ve nt t he m, a n d h o w t o treat t he m.  
U C S F will be t he e xcl usi ve o w ner of a n y data a n d disc o veries res ulti n g fr o m t his researc h.  
A n y c o m mercial pr o d uct de vel o pe d at U C S F as a res ult of t hese st u dies w o ul d be fr o m t he a nal ysis of all sa m ples c ollecte d i n t his st u d y, n ot fr o m a n i n di vi d ual s u bject's sa m ple.

T here is s o me ris k fr o m a breac h of c o nfi de ntialit y. We will d o o ur best t o ma ke s ure t hat y o ur pers o nal i nf or mati o n will be ke pt pri vate.  
T he c ha nce t hat t his i nf or mati o n will be gi ve n t o s o me o ne else is ver y s mall.  
If t his i nf or mati o n were release d t o y o u, y o ur fa mil y, or t hir d parties, it c o ul d p ote ntiall y be mis use d. S uc h mis use c o ul d lea d t o a d verse ps yc h ol o gical effects or u n desire d effects o n t he a bilit y of y o u or y o ur fa mil y me m bers t o o btai n a j o b or i ns ura nce.  
T he t y pes of me dical i nf or mati o n t hat c o ul d be c ollecte d are y o ur pre vi o us me dical hist or y, la b orat or y val ues, t y pe of ca ncer, a n d t u m or sta gi n g.  
  
I n or der t o mi ni mize t hese p ote ntial ris ks, all researc h i nf or mati o n o btai ne d f or y o ur bl o o d sa m ple a n d me dical rec or ds will be ke pt c o nfi de ntial as descri be d a b o ve.

T here is s o me ris k fr o m a breac h of c o nfi de ntialit y. We will d o o ur best t o ma ke s ure t hat y o ur pers o nal i nf or mati o n will be ke pt pri vate.  
T he c ha nce t hat t his i nf or mati o n will be gi ve n t o s o me o ne else is ver y s mall.  
If t his i nf or mati o n were release d t o y o u, y o ur fa mil y, or t hir d parties, it c o ul d p ote ntiall y be mis use d. S uc h mis use c o ul d lea d t o a d verse ps yc h ol o gical effects or u n desire d effects o n t he a bilit y of y o u or y o ur fa mil y me m bers t o o btai n a j o b or i ns ura nce.  
T he t y pes of me dical i nf or mati o n t hat c o ul d be c ollecte d are y o ur pre vi o us me dical hist or y, la b orat or y val ues, t y pe of ca ncer, a n d t u m or sta gi n g. I n or der t o mi ni mize t hese p ote ntial ris ks, all researc h i nf or mati o n o btai ne d f or y o ur bl o o d  
  
sa m ple a n d me dical rec or ds will be ke pt c o nfi de ntial as descri be d a b o ve.
Clinical trial: NCT02494921
Section: Procedures
Subsections: W H At Will H A P Pe N If I T A Ke P Art I N T His Rese Arc H St U D Y ?|W H At Will H A P Pe N If I T A Ke P Art I N T His Rese Arc H St U D Y ?|D Osi N G A D Mi Nistr Ati O N I Nstr Ucti O Ns:|D Osi N G A D Mi Nistr Ati O N I Nstr Ucti O Ns:|W H At Will H A P Pe N If I T A Ke P Art I N T His Rese Arc H St U D Y ?|W H At Will H A P Pe N If I T A Ke P Art I N T His Rese Arc H St U D Y ?|D Osi N G A D Mi Nistr Ati O N I Nstr Ucti O Ns:|D Osi N G A D Mi Nistr Ati O N I Nstr Ucti O Ns:

Y o u will recei ve o ne of t hree d osa ges of ri b ocicli b, i n c o m bi nati o n wit h a sta n dar d d ose of d oceta xel a n d pre d nis o ne. Gr o u ps of t hree t o si x patie nts will recei ve treat me nt at a gi ve n d osa ge le vel of ri b ocicli b. If, d uri n g t he first 2 8 da ys of treat me nt, fe w seri o us si de effects are o bser ve d, a ne w gr o u p of t hree t o si x patie nts will j oi n t he st u d y. Eac h gr o u p of patie nts will be treate d wit h t he sta n dar d d ose of d oceta xel a n d pre d nis o ne, gi ve n t o get her wit h i ncreasi n g d oses of ri b ocicli b, u ntil t he hi g hest t olera ble d oses are i de ntifie d.  
Y o u will be treate d wit h t he c o m bi nati o n of ri b ocicli b pl us d oceta xel + pre d nis o ne f or u p t o 9 c ycles. If t here is n o e vi de nce of pr o gressi o n after 9 c ycles, y o u ma y c o nti n ue o n si n gle a ge nt mai nte na nce ri b ocicli b u ntil t he ti me of disease pr o gressi o n. T he d ose of ri b ocicli b use d d uri n g mai nte na nce will be t he sa me d ose as t hat i m me diatel y prece di n g cessati o n of d oceta xel treat me nt.  
W hic h d ose of ri b ocicli b y o u recei ve will de pe n d o n t he pr o gress of t he st u d y a n d t he si de effects see n wit h ot her patie nts o n t he st u d y. Y o u will n ot be a ble t o c h o ose w hic h d ose of ri b ocicli b y o u recei ve.  
Y o u will be as ke d if y o u all o w f urt her researc h t o be perf or me d o n left o ver t u m or sa m ples.  
W het her or n ot y o u a gree t o t his o pti o nal researc h will n ot affect y o ur a bilit y t o partici pate i n t he mai n p orti o n of t he st u d y. Please refer t o t he e n d of t his c o nse nt f or m f or a n y i nf or mati o n a b o ut o pti o nal researc h.

Y o u will recei ve o ne of t hree d osa ges of ri b ocicli b, i n c o m bi nati o n wit h a sta n dar d d ose of d oceta xel a n d pre d nis o ne. Gr o u ps of t hree t o si x patie nts will recei ve treat me nt at a gi ve n d osa ge le vel of ri b ocicli b. If, d uri n g t he first 2 8 da ys of treat me nt, fe w seri o us si de effects are o bser ve d, a ne w gr o u p of t hree t o si x patie nts will j oi n t he st u d y. Eac h gr o u p of patie nts will be treate d wit h t he sta n dar d d ose of d oceta xel a n d pre d nis o ne, gi ve n t o get her wit h i ncreasi n g d oses of ri b ocicli b, u ntil t he hi g hest t olera ble d oses are i de ntifie d.  
Y o u will be treate d wit h t he c o m bi nati o n of ri b ocicli b pl us d oceta xel + pre d nis o ne f or u p t o 9 c ycles. If t here is n o e vi de nce of pr o gressi o n after 9 c ycles, y o u ma y c o nti n ue o n si n gle a ge nt mai nte na nce ri b ocicli b u ntil t he ti me of disease pr o gressi o n. T he d ose of ri b ocicli b use d d uri n g mai nte na nce will be t he sa me d ose as t hat i m me diatel y prece di n g cessati o n of d oceta xel treat me nt.  
W hic h d ose of ri b ocicli b y o u recei ve will de pe n d o n t he pr o gress of t he st u d y a n d t he si de effects see n wit h ot her patie nts o n t he st u d y. Y o u will n ot be a ble t o c h o ose w hic h d ose of ri b ocicli b y o u recei ve.  
Y o u will be as ke d if y o u all o w f urt her researc h t o be perf or me d o n left o ver t u m or sa m ples.  
W het her or n ot y o u a gree t o t his o pti o nal researc h will n ot affect y o ur a bilit y t o partici pate i n t he mai n p orti o n of t he st u d y. Please refer t o t he e n d of t his c o nse nt f or m f or a n y i nf or mati o n a b o ut o pti o nal researc h.

D oceta xel will be a d mi nistere d t hr o u g h o ne of y o ur vei ns o n t he first da y of eac h 3- wee k treat me nt c ycle.  
Pre d nis o ne will be ta ke n orall y t wice dail y e ver y da y of eac h 3- wee k c ycle.  
P a g e 2 of 2 5 C C \# 1 4 5 5 1 5  
  
Ri b ocicli b will be ta ke n orall y o nce dail y o n da ys 1- 4 a n d 8- 1 5 of eac h 3- wee k c ycle.  
Fil grasti m (als o calle d Ne u p o ge n) will be a d mi nistere d u n der t he s ki n o n da ys 5- 7 of eac h 3- wee k c ycle as well as a d diti o nal d oses as nee de d.  
O n m ost da ys, y o u will ta ke st u d y dr u gs at h o me. O n t he da ys y o u c o me t o cli nic, y o u will wait t o ta ke t he st u d y dr u gs d uri n g t he visit o nce y o u are i nstr ucte d t o d o s o.  
Y o u s h o ul d s wall o w ri b ocicli b ca ps ules wit h a lar ge glass of water at t he sa me ti me eac h m or ni n g.  
Y o u s h o ul d s wall o w t he ri b ocicli b ca ps ules w h ole a n d n ot c he w, cr us h, or o pe n t he m.  
Y o u s h o ul d ta ke pre d nis o ne ta blets i n t he m or ni n g a n d mi d-after n o o n wit h f o o d.  
If y o u v o mit after ta ki n g a d ose, d o n ot re peat t he d ose.  
D o n ot miss a n y d oses. If y o u f or get t o ta ke y o ur st u d y dr u gs b ut re me m ber wit hi n si x h o urs of w he n y o u were s u p p ose d t o ta ke t he m, y o u s h o ul d ta ke t he dr u gs. If it is m ore t ha n si x h o urs, y o u s h o ul d s ki p t he m.  
T he st u d y d oct or will i nstr uct y o u o n h o w ma n y ca ps ules or ta blets of eac h dr u g y o u s h o ul d ta ke.  
A v oi d c o ns u m pti o n of gra pefr uit, Se ville ora n ges, p o mel os, a n d star fr uit or pr o d ucts c o ntai ni n g t he j uice of eac h (i ncl u di n g ja ms a n d mar mala des) d uri n g t he st u d y a n d f or 7 da ys pri or t o t he first d ose of ri b ocicli b. Re g ular ora n ge j uice is all o we d.

D oceta xel will be a d mi nistere d t hr o u g h o ne of y o ur vei ns o n t he first da y of eac h 3- wee k treat me nt c ycle.  
Pre d nis o ne will be ta ke n orall y t wice dail y e ver y da y of eac h 3- wee k c ycle.
P a g e 2 of 2 5 C C \# 1 4 5 5 1 5  
Ri b ocicli b will be ta ke n orall y o nce dail y o n da ys 1- 4 a n d 8- 1 5 of eac h 3- wee k c ycle.  
  
Fil grasti m (als o calle d Ne u p o ge n) will be a d mi nistere d u n der t he s ki n o n da ys 5- 7 of eac h 3- wee k c ycle as well as a d diti o nal d oses as nee de d.  
O n m ost da ys, y o u will ta ke st u d y dr u gs at h o me. O n t he da ys y o u c o me t o cli nic, y o u will wait t o ta ke t he st u d y dr u gs d uri n g t he visit o nce y o u are i nstr ucte d t o d o s o.  
Y o u s h o ul d s wall o w ri b ocicli b ca ps ules wit h a lar ge glass of water at t he sa me ti me eac h m or ni n g.  
Y o u s h o ul d s wall o w t he ri b ocicli b ca ps ules w h ole a n d n ot c he w, cr us h, or o pe n t he m.  
Y o u s h o ul d ta ke pre d nis o ne ta blets i n t he m or ni n g a n d mi d-after n o o n wit h f o o d.  
If y o u v o mit after ta ki n g a d ose, d o n ot re peat t he d ose.  
D o n ot miss a n y d oses. If y o u f or get t o ta ke y o ur st u d y dr u gs b ut re me m ber wit hi n si x h o urs of w he n y o u were s u p p ose d t o ta ke t he m, y o u s h o ul d ta ke t he dr u gs. If it is m ore t ha n si x h o urs, y o u s h o ul d s ki p t he m.  
T he st u d y d oct or will i nstr uct y o u o n h o w ma n y ca ps ules or ta blets of eac h dr u g y o u s h o ul d ta ke.  
A v oi d c o ns u m pti o n of gra pefr uit, Se ville ora n ges, p o mel os, a n d star fr uit or pr o d ucts c o ntai ni n g t he j uice of eac h (i ncl u di n g ja ms a n d mar mala des) d uri n g t he st u d y a n d f or 7 da ys pri or t o t he first d ose of ri b ocicli b. Re g ular ora n ge j uice is all o we d.

Y o u will recei ve o ne of t hree d osa ges of ri b ocicli b, i n c o m bi nati o n wit h a sta n dar d d ose of d oceta xel a n d pre d nis o ne. Gr o u ps of t hree t o si x patie nts will recei ve treat me nt at a gi ve n d osa ge le vel of ri b ocicli b. If, d uri n g t he first 2 8 da ys of treat me nt, fe w seri o us si de effects are o bser ve d, a ne w gr o u p of t hree t o si x patie nts will j oi n t he st u d y. Eac h gr o u p of patie nts will be treate d wit h t he sta n dar d d ose of d oceta xel a n d pre d nis o ne, gi ve n t o get her wit h i ncreasi n g d oses of ri b ocicli b, u ntil t he hi g hest t olera ble d oses are i de ntifie d.  
Y o u will be treate d wit h t he c o m bi nati o n of ri b ocicli b pl us d oceta xel + pre d nis o ne f or u p t o 9 c ycles. If t here is n o e vi de nce of pr o gressi o n after 9 c ycles, y o u ma y c o nti n ue o n si n gle a ge nt mai nte na nce ri b ocicli b u ntil t he ti me of disease pr o gressi o n. T he d ose of ri b ocicli b use d d uri n g mai nte na nce will be t he sa me d ose as t hat i m me diatel y prece di n g cessati o n of d oceta xel treat me nt.  
W hic h d ose of ri b ocicli b y o u recei ve will de pe n d o n t he pr o gress of t he st u d y a n d t he si de effects see n wit h ot her patie nts o n t he st u d y. Y o u will n ot be a ble t o c h o ose w hic h d ose of ri b ocicli b y o u recei ve.  
Y o u will be as ke d if y o u all o w f urt her researc h t o be perf or me d o n left o ver t u m or sa m ples.  
W het her or n ot y o u a gree t o t his o pti o nal researc h will n ot affect y o ur a bilit y t o partici pate i n t he mai n p orti o n of t he st u d y. Please refer t o t he e n d of t his c o nse nt f or m f or a n y i nf or mati o n a b o ut o pti o nal researc h.

Y o u will recei ve o ne of t hree d osa ges of ri b ocicli b, i n c o m bi nati o n wit h a sta n dar d d ose of d oceta xel a n d pre d nis o ne. Gr o u ps of t hree t o si x patie nts will recei ve treat me nt at a gi ve n d osa ge le vel of ri b ocicli b. If, d uri n g t he first 2 8 da ys of treat me nt, fe w seri o us si de effects are o bser ve d, a ne w gr o u p of t hree t o si x patie nts will j oi n t he st u d y. Eac h gr o u p of patie nts will be treate d wit h t he sta n dar d d ose of d oceta xel a n d pre d nis o ne, gi ve n t o get her wit h i ncreasi n g d oses of ri b ocicli b, u ntil t he hi g hest t olera ble d oses are i de ntifie d.  
Y o u will be treate d wit h t he c o m bi nati o n of ri b ocicli b pl us d oceta xel + pre d nis o ne f or u p t o 9 c ycles. If t here is n o e vi de nce of pr o gressi o n after 9 c ycles, y o u ma y c o nti n ue o n si n gle a ge nt mai nte na nce ri b ocicli b u ntil t he ti me of disease pr o gressi o n. T he d ose of ri b ocicli b use d d uri n g mai nte na nce will be t he sa me d ose as t hat i m me diatel y prece di n g cessati o n of d oceta xel treat me nt.  
W hic h d ose of ri b ocicli b y o u recei ve will de pe n d o n t he pr o gress of t he st u d y a n d t he si de effects see n wit h ot her patie nts o n t he st u d y. Y o u will n ot be a ble t o c h o ose w hic h d ose of ri b ocicli b y o u recei ve.  
Y o u will be as ke d if y o u all o w f urt her researc h t o be perf or me d o n left o ver t u m or sa m ples.  
W het her or n ot y o u a gree t o t his o pti o nal researc h will n ot affect y o ur a bilit y t o partici pate i n t he mai n p orti o n of t he st u d y. Please refer t o t he e n d of t his c o nse nt f or m f or a n y i nf or mati o n a b o ut o pti o nal researc h.

D oceta xel will be a d mi nistere d t hr o u g h o ne of y o ur vei ns o n t he first da y of eac h 3- wee k treat me nt c ycle.  
Pre d nis o ne will be ta ke n orall y t wice dail y e ver y da y of eac h 3- wee k c ycle.  
P a g e 2 of 2 5 C C \# 1 4 5 5 1 5  
  
Ri b ocicli b will be ta ke n orall y o nce dail y o n da ys 1- 4 a n d 8- 1 5 of eac h 3- wee k c ycle.  
Fil grasti m (als o calle d Ne u p o ge n) will be a d mi nistere d u n der t he s ki n o n da ys 5- 7 of eac h 3- wee k c ycle as well as a d diti o nal d oses as nee de d.  
O n m ost da ys, y o u will ta ke st u d y dr u gs at h o me. O n t he da ys y o u c o me t o cli nic, y o u will wait t o ta ke t he st u d y dr u gs d uri n g t he visit o nce y o u are i nstr ucte d t o d o s o.  
Y o u s h o ul d s wall o w ri b ocicli b ca ps ules wit h a lar ge glass of water at t he sa me ti me eac h m or ni n g.  
Y o u s h o ul d s wall o w t he ri b ocicli b ca ps ules w h ole a n d n ot c he w, cr us h, or o pe n t he m.  
Y o u s h o ul d ta ke pre d nis o ne ta blets i n t he m or ni n g a n d mi d-after n o o n wit h f o o d.  
If y o u v o mit after ta ki n g a d ose, d o n ot re peat t he d ose.  
D o n ot miss a n y d oses. If y o u f or get t o ta ke y o ur st u d y dr u gs b ut re me m ber wit hi n si x h o urs of w he n y o u were s u p p ose d t o ta ke t he m, y o u s h o ul d ta ke t he dr u gs. If it is m ore t ha n si x h o urs, y o u s h o ul d s ki p t he m.  
T he st u d y d oct or will i nstr uct y o u o n h o w ma n y ca ps ules or ta blets of eac h dr u g y o u s h o ul d ta ke.  
A v oi d c o ns u m pti o n of gra pefr uit, Se ville ora n ges, p o mel os, a n d star fr uit or pr o d ucts c o ntai ni n g t he j uice of eac h (i ncl u di n g ja ms a n d mar mala des) d uri n g t he st u d y a n d f or 7 da ys pri or t o t he first d ose of ri b ocicli b. Re g ular ora n ge j uice is all o we d.

D oceta xel will be a d mi nistere d t hr o u g h o ne of y o ur vei ns o n t he first da y of eac h 3- wee k treat me nt c ycle.  
Pre d nis o ne will be ta ke n orall y t wice dail y e ver y da y of eac h 3- wee k c ycle.
P a g e 2 of 2 5 C C \# 1 4 5 5 1 5  
Ri b ocicli b will be ta ke n orall y o nce dail y o n da ys 1- 4 a n d 8- 1 5 of eac h 3- wee k c ycle.  
  
Fil grasti m (als o calle d Ne u p o ge n) will be a d mi nistere d u n der t he s ki n o n da ys 5- 7 of eac h 3- wee k c ycle as well as a d diti o nal d oses as nee de d.  
O n m ost da ys, y o u will ta ke st u d y dr u gs at h o me. O n t he da ys y o u c o me t o cli nic, y o u will wait t o ta ke t he st u d y dr u gs d uri n g t he visit o nce y o u are i nstr ucte d t o d o s o.  
Y o u s h o ul d s wall o w ri b ocicli b ca ps ules wit h a lar ge glass of water at t he sa me ti me eac h m or ni n g.  
Y o u s h o ul d s wall o w t he ri b ocicli b ca ps ules w h ole a n d n ot c he w, cr us h, or o pe n t he m.  
Y o u s h o ul d ta ke pre d nis o ne ta blets i n t he m or ni n g a n d mi d-after n o o n wit h f o o d.  
If y o u v o mit after ta ki n g a d ose, d o n ot re peat t he d ose.  
D o n ot miss a n y d oses. If y o u f or get t o ta ke y o ur st u d y dr u gs b ut re me m ber wit hi n si x h o urs of w he n y o u were s u p p ose d t o ta ke t he m, y o u s h o ul d ta ke t he dr u gs. If it is m ore t ha n si x h o urs, y o u s h o ul d s ki p t he m.  
T he st u d y d oct or will i nstr uct y o u o n h o w ma n y ca ps ules or ta blets of eac h dr u g y o u s h o ul d ta ke.  
A v oi d c o ns u m pti o n of gra pefr uit, Se ville ora n ges, p o mel os, a n d star fr uit or pr o d ucts c o ntai ni n g t he j uice of eac h (i ncl u di n g ja ms a n d mar mala des) d uri n g t he st u d y a n d f or 7 da ys pri or t o t he first d ose of ri b ocicli b. Re g ular ora n ge j uice is all o we d.