Vandetanib Gemcitabine Or Placebo Plus Gemcitabine Or Vandetanib Monotherapy In Advanced Biliary Tract Cancer
Condition: Biliary Tract Cancer; Gallbladder Cancer; Cancer Of The Extrahepatic Bile Duct; Ampullary Carcinoma
MeSH terms: Carcinoma; Cholangiocarcinoma; Biliary Tract Neoplasms; Gallbladder Neoplasms
Intervention: ZD6474, Vandetanib; ZD6474, Vandetanib; Gemcitabine; Placebo matching ZD6474
Intervention description: 300 mg as a once daily oral dose, from Day 1 until disease progression or unacceptable toxicity or consent withdrawal whichever occurs first; 100 mg as a once daily oral dose, from Day 1 until disease progression or unacceptable toxicity or consent withdrawal whichever occurs first; administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to 6 cycles or until disease progression or unacceptable toxicity or consent withdrawal whichever occurs first; Placebo to match ZD6474 100 mg as a once daily oral dose, from Day 1 until disease progression or unacceptable toxicity or consent withdrawal whichever occurs first
Intervention MeSH terms: Gemcitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 174.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Intrahepatic; Cholangiocarcinoma; Vandetanib; Zactima; Advanced; Biliary; Tract; Gallbladder; Extrahepatic Bile Duct; Intrahepatic Cholangiocarcinoma; Ampullary Carcinoma

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