Bevacizumab and Erlotinib Hydrochloride in Treating Patients With Metastatic or Unresectable Biliary Tumors
Cholangiocarcinoma of the Extrahepatic Bile Duct
Cholangiocarcinoma of the Gallbladder
Recurrent Extrahepatic Bile Duct Cancer
Recurrent Gallbladder Cancer
Unresectable Extrahepatic Bile Duct Cancer
Unresectable Gallbladder Cancer
Drug: erlotinib hydrochloride
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial of Bevacizumab and Erlotinib in Patients With Advanced Biliary Tumors|
- Number of Confirmed Tumor Responses. [ Time Frame: After 6 courses of treatment. Each course lasts 28 days. ] [ Designated as safety issue: No ]
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.
- Survival Time [ Time Frame: From registration to death due to any cause, assessed up to 3 years ] [ Designated as safety issue: No ]Estimated using the method of Kaplan-Meier (1958).
- Time to Disease Progression [ Time Frame: From registration to documentation of disease progression, assessed up to 3 years ] [ Designated as safety issue: No ]Estimated using the method of Kaplan-Meier (1958).
- Duration of Response [ 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 ] [ Designated as safety issue: No ]Point estimates and 95% confidence intervals were calculated using the method of Duffy and Santner (1987).
|Study Start Date:||May 2006|
|Study Completion Date:||June 2010|
|Primary Completion Date:||October 2008 (Final data collection date for primary outcome measure)|
Experimental: Bevacizumab and Erlotinib Hydrochloride
Patients receive 5 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15 and 150 mg oral erlotinib hydrochloride daily on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.
Tumor tissue and blood specimens are collected periodically for correlative studies. Specimens are examined by immunohistochemistry for epidermal growth factor receptor (EGFR) and P-EGFR protein levels; AKT p-AKT, mitogen-activated protein kinase (MAPK) and P-MAPK protein levels; and vascular endothelial growth factor receptor (VEGFR)-1 and VEGFR-2 protein levels. EGFR mutations are detected by laser capture microdissection. Enzyme-linked immunosorbent assay is used to measure total and free serum VEGF levels.
Drug: erlotinib hydrochloride
Given orally, 150 mg, once daily.
Other Names:Biological: bevacizumab
Given IV, 5mg/kg on days 1 and 15 every cycle
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00356889
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||William Schelman||Mayo Clinic|