This phase II trial is studying how well giving bevacizumab together with erlotinib hydrochloride works in treating patients with metastatic or unresectable biliary tumors. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Bevacizumab and erlotinib hydrochloride may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving bevacizumab together with erlotinib hydrochloride may kill more tumor cells.
PRIMARY OBJECTIVES: I. Evaluate the objective response rate in patients with metastatic or unresectable cholangiocarcinoma treated with bevacizumab and erlotinib hydrochloride. SECONDARY OBJECTIVES: I. Evaluate time to progression in these patients. II. Evaluate overall and progression-free survival of these patients. III. Evaluate the adverse events associated with this regimen. OUTLINE: This is an open-label, multicenter study. Patients receive bevacizumab intravenously (IV) over 30-90 minutes on days 1 and 15 and oral erlotinib hydrochloride daily on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression. After completion of study therapy, patients are followed periodically for up to 3 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
56
Given orally, 150 mg, once daily.
Given IV, 5mg/kg on days 1 and 15 every cycle
Mayo Clinic
Rochester, Minnesota, United States
Number of Confirmed Tumor Responses.
Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the target lesions. A confirmed tumor response is defined to be either a Complete Response or a Partial Response noted as the objective status on 2 consecutive evaluations at least 4 weeks apart. Confirmed tumor responses will be evaluated using the first 6 cycles of treatment. All patients meeting the eligibility criteria who have signed a consent form and have begun treatment and had one post-baseline disease assessment will be evaluable for response. Forty-nine of the 53 eligible patients had at least one post-baseline disease assessment and were evaluable for this endpoint.
Time frame: After 6 courses of treatment. Each course lasts 28 days.
Survival Time
Estimated using the method of Kaplan-Meier (1958).
Time frame: From registration to death due to any cause, assessed up to 3 years
Time to Disease Progression
Estimated using the method of Kaplan-Meier (1958).
Time frame: From registration to documentation of disease progression, assessed up to 3 years
Duration of Response
Point estimates and 95% confidence intervals were calculated using the method of Duffy and Santner (1987).
Time frame: From the date at which the patient's objective status is first noted to be either a CR or PR to the date progression is documented, assessed up to 3 years
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