Clinical trial NCT00350948: Phase 3 Randomized Study of Telcyta + Doxorubicin Versus Doxorubicin in Platinum Refractory or Resistant Ovarian Cancer
Official title: Phase 3 Randomized Study of TLK286 (Telcyta®) in Combination With Liposomal Doxorubicin (Doxil/Caelyx)Versus Liposomal Doxorubicin (Doxil/Caelyx) as Second-Line Therapy in Platinum Refractory or Resistant Ovarian Cancer (ASSIST-5)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Ovarian Neoplasms
Keywords: Ovary
Lead sponsor: Telik
Sponsor class: INDUSTRY
First posted: 2006-07-11
Enrollment: 244
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this research study is to determine if Telcyta® given in combination with liposomal doxorubicin is more effective than liposomal doxorubicin alone in treating women who have recurrent ovarian epithelial cancer, fallopian tube cancer or primary peritoneal cancer that is refractory or resistant to platinum chemotherapy.

Detailed description: This is a randomized, open label, multicenter, multinational Phase 3 study of TLK286 (Telcyta) in combination with liposomal doxorubicin (Doxil/Caelyx) as compared to the active control therapy with liposomal doxorubicin (Doxil/Caelyx) as second line therapy in patients with platinum refractory or resistant recurrent ovarian cancer. Patients will be randomly assigned to receive either TLK286 (Telcyta) in combination with liposomal doxorubicin (Doxil/Caelyx) or active control liposomal doxorubicin (Doxil/Caelyx).

Eligibility criteria: Inclusion Criteria:

* Are a woman 18 years of age or older
* Have histologically or cytologically confirmed epithelial cancer or primary peritoneal cancer
* Have platinum refractory or resistant cancer
* Measurable disease according to radiographic RECIST criteria progression

Exclusion Criteria:

* Had treatment with first-line chemotherapy other than a platinum-containing regimen
* Have clinically significant cardiac disease
* Have any sign of intestinal obstruction interfering with nutrition
* Are pregnant or lactating
* Had prior treatment with liposomal doxorubicin
* Had prior treatment with Telcyta

Primary outcomes:
measure: To demonstrate superiority in progression-free survival of TLK286 in combination with liposomal doxorubicin as compared with the active control arm liposomal doxorubicin
timeFrame: Once 244 planned pts. received at least 2 cycles of study treatment(s)
Secondary outcomes:
measure: To evaluate and compare the safety profile of each treatment arm
timeFrame: Any patient who received 1 dose of study treatment(s) will be evaluable for safety.
Other outcomes:
Locations:
city: Casa Grande
country: United States
facility: Desert Oasis Cancer Center
state: Arizona
city: Little Rock
country: United States
facility: Hematology Oncology Services of Arkansas
state: Arkansas
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
city: Antioch
country: United States
facility: East Bay Medical Oncology/Hematology Medical Associates, Inc.
state: California
city: Concord
country: United States
facility: Bay Area Cancer Research Group, LLC
state: California
city: Concord
country: United States
facility: East Bay Medical Oncology/Hematology Medical Associates
state: California
city: Fresno
country: United States
facility: California Oncology of the Central Valley
state: California
city: Newport Beach
country: United States
facility: Women's Cancer Research Foundation
state: California
city: Poway
country: United States
facility: Southwest Cancer Care
state: California
city: Rancho Mirage
country: United States
facility: Desert Hematology Oncology Medical Group
state: California
city: San Diego
country: United States
facility: Southern California Permanente Medical Group
state: California
city: San Leandro
country: United States
facility: East Bay Medical Oncoogy/Hematology Medical Associates, Inc.
state: California
city: Walnut Creek
country: United States
facility: Diablo Valley Oncology & Hematology Medical Group, Inc.
state: California
city: Hollywood
country: United States
facility: Gynecologic Oncology Associates, Inc
state: Florida
city: Jacksonville
country: United States
facility: Shands Jacksonville Medical Center
state: Florida
city: Jacksonville
country: United States
facility: University of Florida College of Medicine-Jacksonville
state: Florida
city: Orlando
country: United States
facility: Florida Hospital Cancer Institute
state: Florida
city: Orlando
country: United States
facility: Florida Hospital
state: Florida
city: Pembroke Pines
country: United States
facility: Gynecologic Oncology Associates, Inc
state: Florida
city: Savannah
country: United States
facility: Memorial Health University Medical Center
state: Georgia
city: Honolulu
country: United States
facility: Kaiser Permanente Moanalua Medical Center
state: Hawaii
city: Flossmoor
country: United States
facility: Flossmoor Cancer Care (JOHA DBA)
state: Illinois
city: Joliet
country: United States
facility: Joliet Oncology-Hematology Associates
state: Illinois
city: Joliet
country: United States
facility: Joliet Oncology-Hematology Associates, LTD.
state: Illinois
city: Kankakee
country: United States
facility: Kankakee Cancer Center (JOHA DBA)
state: Illinois
city: Morris
country: United States
facility: Joliet Oncology-Hematology Associates
state: Illinois
city: Indianapolis
country: United States
facility: St. Vincent Gynecologic Oncology
state: Indiana
city: Lexington
country: United States
facility: Central Baptist Hospital
state: Kentucky
city: Metairie
country: United States
facility: Hematology and Oncology Specialists, LLC
state: Louisiana
city: Shreveport
country: United States
facility: LSU Health Sciences Center
state: Louisiana
city: Bethesda
country: United States
facility: Center for Cancer and Blood Disorders
state: Maryland
city: St. Louis
country: United States
facility: Arch Medical Services
state: Missouri
city: Omaha
country: United States
facility: Hematology & Oncology Consultants P.C.
state: Nebraska
city: Scottsbluff
country: United States
facility: Horizon's West Medical Group
state: Nebraska
city: Scottsbluff
country: United States
facility: The Women's Center of Western Nebraska
state: Nebraska
city: Babylon
country: United States
facility: Schwaartz Gynecologic Oncology, PLLC
state: New York
city: Cooperstown
country: United States
facility: The Mary Imogene Bassett Hospital
state: New York
city: Lake Success
country: United States
facility: Monter Cancer Center
state: New York
city: Manhasset
country: United States
facility: North Shore University Hospital
state: New York
city: New Hyde Park
country: United States
facility: Long Island Jewish Medical Center
state: New York
city: Asheville
country: United States
facility: Hope A Women's Cancer Center
state: North Carolina
city: Charlotte
country: United States
facility: Blumenthal Cancer Center
state: North Carolina
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
city: Charlotte
country: United States
facility: Presbyterian Hospital
state: North Carolina
city: Lexington
country: United States
facility: Piedmont Hematology Oncology Associates-Lexington Satellite
state: North Carolina
city: Winston Salem
country: United States
facility: Piedmont Hematology Oncology Associates
state: North Carolina
city: Fargo
country: United States
facility: Dakota Cancer Institute/Dakota Clinic Ltd.
state: North Dakota
city: Columbus
country: United States
facility: Gynecologic Oncology & Pelvic Surgery Associates
state: Ohio
city: Toledo
country: United States
facility: Garth Phibbs, M.D., FACOG
state: Ohio
city: Toledo
country: United States
facility: The Toledo Hospital
state: Ohio
city: Portland
country: United States
facility: Kaiser Permanente NW, Oncology/Hematology
state: Oregon
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Abington
country: United States
facility: Abington Memorial Hospital
state: Pennsylvania
city: Dunmore
country: United States
facility: Hematology & Oncology Associates of NEPA
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Magee Women's Hospital of UPMC
state: Pennsylvania
city: Upland
country: United States
facility: Associates in Hematolog-Oncology, P.C.
state: Pennsylvania
city: Charleston
country: United States
facility: Carolina Center of Gynecologic Oncology
state: South Carolina
city: Columbia
country: United States
facility: Palmetto Health Alliance-Richland
state: South Carolina
city: Columbia
country: United States
facility: South Carolina Oncology Associates
state: South Carolina
city: Arlington
country: United States
facility: Arlington Cancer Center
state: Texas
city: Trophy Club
country: United States
facility: Arlington Cancer Center
state: Texas
city: Danville
country: United States
facility: Danville Hematology & Oncology, Inc.
state: Virginia
city: Roanoke
country: United States
facility: Carilion GYN Oncology Associates
state: Virginia
city: Antwerpen
country: Belgium
facility: Algemeen Ziekenhuis Middelheim
city: Kortrijk
country: Belgium
facility: A.Z. Groeninge Oncologish Centrum
city: Leuven
country: Belgium
facility: Universitaire Ziekenhuizen Leuven Dienst Oncologie
city: Belo Horizonte
country: Brazil
facility: Hospital Vera Cruz-Instituto de Oncologia
state: MG
city: Cerqueria Cesar
country: Brazil
facility: Centr de Oncologia do Instituto de Radiologia do Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
state: Sao Paulo
city: Rua Dona Siilveria
country: Brazil
facility: Fundacao Hospital Amaral Carvalho
state: Sao Paulo
city: London
country: United Kingdom
facility: Guy's & St. Thomas Cancer Centre
state: England
city: Dundee
country: United Kingdom
facility: Ninewells Hospital and Medical School
state: Scotland
Study officials:
affiliation: Telik
name: Gail L. Brown, MD, MBA
role: STUDY_DIRECTOR
References:
citation: Vergote I, Finkler NJ, Hall JB, Melnyk O, Edwards RP, Jones M, Keck JG, Meng L, Brown GL, Rankin EM, Burke JJ, Boccia RV, Runowicz CD, Rose PG. Randomized phase III study of canfosfamide in combination with pegylated liposomal doxorubicin compared with pegylated liposomal doxorubicin alone in platinum-resistant ovarian cancer. Int J Gynecol Cancer. 2010 Jul;20(5):772-80. doi: 10.1111/igc.0b013e3181daaf59.