Clinical trial NCT00753675: Vandetanib Gemcitabine Or Placebo Plus Gemcitabine Or Vandetanib Monotherapy In Advanced Biliary Tract Cancer
Official title: A Randomized, Multicentre, Phase II, Parallel-Group Trial of Vandetanib Monotherapy or Vandetanib in Combination With Gemcitabine Versus Gemcitabine Plus Vandetanib Matching Placebo in Subjects With Advanced Biliary Tract Cancer (Gallbladder Cancer, Cancer of the Extrahepatic Bile Duct, Intrahepatic Cholangiocarcinoma and Ampullary Carcinoma)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Biliary Tract Cancer
Gallbladder Cancer
Cancer Of The Extrahepatic Bile Duct
Ampullary Carcinoma
Keywords: Intrahepatic
Cholangiocarcinoma
Vandetanib
Zactima
Advanced
Biliary
Tract
Gallbladder
Extrahepatic Bile Duct
Intrahepatic Cholangiocarcinoma
Ampullary Carcinoma
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-09-16
Enrollment: 174
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of the trial is to determine the efficacy of VANDETANIB monotherapy or VANDETANIB plus GEMCITABINE or PLACEBO plus GEMCITABINE in prolonging the progression-free survival (PFS) at the trial closure in patients with advanced (unresectable or metastatic) biliary tract cancer.


Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically-confirmed advanced (unresectable or metastatic) biliary tract cancer (gallbladder cancer, cancer of the extrahepatic bile duct, intrahepatic cholangiocarcinoma and ampullary carcinoma)
* Patients must have measurable or evaluable but non-measurable disease
* Chemotherapy-naïve (prior chemotherapy in the adjuvant setting completed more than 3 months before the trial entry is accepted).
* WHO performance status 0 to 2: patients must have a WHO PS ≤ 2

Exclusion Criteria:

* Patients must not have received prior systemic therapy for advanced (unresectable or metastatic) disease; prior chemotherapy in the adjuvant setting within 3 months before the trial entry is accepted
* Inadequate end-organ function or Evidence of severe or uncontrolled systemic disease or any concurrent condition which in the Investigator's opinion makes it undesirable for the patient to participate in the trial or which would jeopardize compliance wit
* Significant cardiovascular event (e.g. myocardial infarction, superior vena cava \[SVC\] syndrome, New York Heart Association \[NYHA\] classification of heart disease ³2) within 3 months before entry, or presence of cardiac disease that in the opinion of
* History of arrhythmia or QTc with Bazett's correction unmeasurable or ≥ 480 msec on screening ECG

Primary outcomes:
measure: Progression Free Survival
timeFrame: up to 1032 days
Secondary outcomes:
measure: Objective Tumor Response Rate (CR+PR),
timeFrame: up to 1032 days
measure: Disease Control Rate (CR+PR+SD)
timeFrame: up to 1032 days
measure: Duration of Response (DOR)
timeFrame: up to 1032 days
measure: Overall Survival
timeFrame: up to 1032 days
Other outcomes:
Locations:
city: Brescia
country: Italy
facility: Research Site
state: BS
city: Firenze
country: Italy
facility: Research Site
state: FI
city: Genova
country: Italy
facility: Research Site
state: GE
city: Milano
country: Italy
facility: Research Site
state: Mi
city: Palermo
country: Italy
facility: Research Site
state: PA
city: Aviano
country: Italy
facility: Research Site
state: PN
city: Parma
country: Italy
facility: Research Site
state: PR
city: Reggio Emilia
country: Italy
facility: Research Site
state: RE
city: Ancona
country: Italy
facility: Research Site
city: Livorno
country: Italy
facility: Research Site
city: Napoli
country: Italy
facility: Research Site
city: Pisa
country: Italy
facility: Research Site
city: Ravenna
country: Italy
facility: Research Site
city: Rho
country: Italy
facility: Research Site
city: Torino
country: Italy
facility: Research Site
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
citation: Wedge SR, Ogilvie DJ, Dukes M, Kendrew J, Chester R, Jackson JA, Boffey SJ, Valentine PJ, Curwen JO, Musgrove HL, Graham GA, Hughes GD, Thomas AP, Stokes ES, Curry B, Richmond GH, Wadsworth PF, Bigley AL, Hennequin LF. ZD6474 inhibits vascular endothelial growth factor signaling, angiogenesis, and tumor growth following oral administration. Cancer Res. 2002 Aug 15;62(16):4645-55.
citation: Santoro A, Gebbia V, Pressiani T, Testa A, Personeni N, Arrivas Bajardi E, Foa P, Buonadonna A, Bencardino K, Barone C, Ferrari D, Zaniboni A, Tronconi MC, Carteni G, Milella M, Comandone A, Ferrari S, Rimassa L. A randomized, multicenter, phase II study of vandetanib monotherapy versus vandetanib in combination with gemcitabine versus gemcitabine plus placebo in subjects with advanced biliary tract cancer: the VanGogh study. Ann Oncol. 2015 Mar;26(3):542-7. doi: 10.1093/annonc/mdu576. Epub 2014 Dec 23.