A Phase II Trial of Bevacizumab and Erlotinib in Patients With Advanced Biliary Tumors
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.
Interventional
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.
No
William Schelman
Principal Investigator
Mayo Clinic
United States: Food and Drug Administration
NCI-2009-00115
NCT00356889
May 2006
February 2009
Name | Location |
---|---|
Mayo Clinic | Rochester, Minnesota 55905 |