Vandetanib Gemcitabine Or Placebo Plus Gemcitabine Or Vandetanib Monotherapy In Advanced Biliary Tract Cancer (VANGOGH)

Genzyme

Status and phase: Completed; Phase 2

Conditions: Gallbladder Cancer; Biliary Tract Cancer; Ampullary Carcinoma; Cancer Of The Extrahepatic Bile Duct

Treatments: Drug: ZD6474, Vandetanib; Drug: Gemcitabine; Drug: Placebo matching ZD6474

Study type: Interventional

Funder types: Industry

Identifiers

NCT00753675

EUDRACT n° 2007-003056-12

D4200L00007

Details and patient eligibility

About

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.

Enrollment: 174 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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174 participants in 3 patient groups, including a placebo group

A

Experimental group

Description:

Vandetanib 300 mg as a once daily oral dose, from Day 1

Treatment:

Drug: ZD6474, Vandetanib

Drug: ZD6474, Vandetanib

B

Experimental group

Description:

Gemcitabine administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg orally once-daily, from Day 1 (after 6 cycles, in the absence of disease progression or unacceptable toxicity, Investigators remain at liberty to continue Gemcitabine plus Vandetanib / Placebo or to continue Vandetanib / Placebo monotherapy)

Treatment:

Drug: ZD6474, Vandetanib

Drug: Gemcitabine

Drug: ZD6474, Vandetanib

C

Placebo Comparator group

Description:

Gemcitabine administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to 6 cycles plus Vandetanib 100 mg Matching Placebo orally once-daily, from Day 1 (after 6 cycles, in the absence of disease progression or unacceptable toxicity, Investigators remain at liberty to continue Gemcitabine plus Vandetanib / Placebo or to continue Vandetanib / Placebo monotherapy).

Treatment:

Drug: Gemcitabine

Drug: Placebo matching ZD6474