A Phase II Trial of Bevacizumab and Erlotinib in Patients With Advanced Biliary Tumors
I. Evaluate the objective response rate in patients with metastatic or unresectable
cholangiocarcinoma treated with bevacizumab and erlotinib hydrochloride.
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.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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.
After 6 courses of treatment. Each course lasts 28 days.
United States: Food and Drug Administration
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