A RANDOMISED, 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) - VANGOGH
- Conditions
- ADVANCED BILIARY TRACT CANCERMedDRA version: 9.1Level: HLGTClassification code 10019815Term: Hepatobiliary neoplasms malignant and unspecified
- Registration Number
- EUCTR2007-003056-12-IT
- Lead Sponsor
- ASTRAZENECA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 174
1.Provision of informed consent 2.Male or Female aged 18 years and over 3.Histologically or citologically-confirmed advanced (unresectable or metastatic) biliary tract cancer (gallbladder cancer, cancer of the extrahepatic bile duct, intrahepatic cholangiocarcinoma and ampullary carcinoma) excluding small cell (oat cell) carcinoma of the hepatobiliary tract. 4.Patients must have measurable or evaluable but non-measurable disease, defined as follows: - Measurable Disease - Patients with measurable disease as defined by the modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria, i.e., the presence of at least one measurable lesion. A measurable lesion is one that can be accurately measured in at least one dimension with the longest diameter ≥ 20 mm using conventional techniques or ≥ 10 mm using spiral Computed Tomography (CT) scan. Clinical lesions will only be considered measurable when they are superficial (e.g., skin nodules, palpable lymph nodes). - Evaluable but Non-measurable Disease - Patients with all lesions below the limits defined above for measureable disease (i.e., longest diameter < 20 mm with conventional techniques or < 10 mm with spiral CT) excluding those patients with only a primary non-measurable lesion and/or with only non-evaluable cancer such as bone metastases, ascites, pleural or pericardia effusions, lymphangitic carcinomatosis of the skin or lung, previously irradiated lesions not in progression, or peritoneal carcinomatosis < 10 mm in diameter with conventional imaging techniques. 5.Chemotherapy-naïve (prior chemotherapy in the adjuvant setting completed more than 3 months before the trial entry is accepted). 6.WHO performance status 0 to 2: patients must have a WHO PS ≤ 2 7.Life expectancy of at least 12 weeks. 8.Negative pregnancy test for women of childbearing potential 9.Provision of informed consent for biomarker research (optional)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1.Histologically or citologically-confirmed small cell (oat cell) carcinoma of the hepatobiliary tract is to be excluded. 2.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. 3.Prior treatment with VEGFR TKIs (previous treatment with bevacizumab [Avastin] is permitted) 4.Prior unanticipated severe reaction to GEMCITABINE therapy or known sensitivity to GEMCITABINE. 5.Radiation therapy within 4 weeks before the start of study therapy, not including local palliative radiation. Prior radiotherapy is accepted as long as target lesions have not been irradiated. Lesions that have received radiation in the advanced setting cannot be included as target lesions unless clear tumour progression has been documented in the lesions since the end of radiation therapy 6.Major surgery within 4 weeks, or incompletely healed surgical incision before starting study therapy or serious, non-healing wound, ulcer, or bone fracture. Insertion of a vascular access device is not considered major/minor surgery. 7.Inadequate end-organ function 8.Known brain metastases or carcinomatous meningitis. Patients with known brain metastases should be excluded from this clinical trial unless asymptomatic or with evidence of clinically SD (no steroid therapy or steroid dose being tapered) for at least 28 days. 9.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 with the protocol
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method