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Completed

NCT Number: NCT00753675

Vandetanib Gemcitabine Or Placebo Plus Gemcitabine Or Vandetanib Monotherapy In Advanced Biliary Tract Cancer

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.

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Key information

Conditions

Biliary Tract Cancer Adenocarcinoma Ampullary Carcinoma Biliary Tract Diseases Biliary Tract Neoplasms Cancer Of The Extrahepatic Bile Duct Carcinoma Cholangiocarcinoma Digestive System Diseases Digestive System Neoplasms Gallbladder Cancer Gallbladder Diseases Gallbladder Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Brescia, BS, Italy

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ZD6474, Vandetanib

Drug

300 mg as a once daily oral dose, from Day 1 until disease progression or unacceptable toxicity or consent withdrawal whichever occurs first

Other names: Zactima

Gemcitabine

Drug

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

Other names: Gemzar

Placebo matching ZD6474

Drug

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

Primary outcomes

  1. Progression Free Survival

    Time frame: up to 1032 days

    Progression was defined as Time from the date of first dose of study medication to progression of disease, or death (it also includes patients who are lost to follow-up or have withdrawn consent) and evaluated with RECIST criteria as an increase of at least 20% in the sum of longest diameter (LD) of target lesion(s) taking as reference the smallest sum of LD since the treatment started or any new lesion(s).

Secondary outcomes

  1. Objective Tumor Response Rate (CR+PR),

    Time frame: up to 1032 days

    Objective Tumor Response Rate was defined as complete response (CR) + partial response (PR) evaluated by RECIST. CR was defined as disappearance of all target lesions. PR was defined as at least 30% decrease in the sum of longest diameters (LD) of target lesion(s) taking as reference the baseline sum of LD

  2. Disease Control Rate (CR+PR+SD)

    Time frame: up to 1032 days

    DCR is the sum of patients with a best overall CR, PR or SD (>=8 weeks) by the patient in the analysis

  3. Duration of Response (DOR)

    Time frame: up to 1032 days

    DOR is defined from the date of first documentation of response until date of PD or death

  4. Overall Survival

    Time frame: up to 1032 days

    OS is defined from the date of randomization to death

Sponsors and collaborators

Lead sponsor

Genzyme, a Sanofi Company

Industry

Registry information

Official study 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)

Acronym: VANGOGH

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Sep 16, 2008
Registry last updated
Oct 10, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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