Bevacizumab and Erlotinib Hydrochloride in Treating Patients With Metastatic or Unresectable Biliary Tumors
|ClinicalTrials.gov Identifier: NCT00356889|
Recruitment Status : Completed
First Posted : July 27, 2006
Results First Posted : May 20, 2013
Last Update Posted : May 28, 2014
|Condition or disease||Intervention/treatment||Phase|
|Cholangiocarcinoma of the Extrahepatic Bile Duct Cholangiocarcinoma of the Gallbladder Gastrointestinal Cancer Recurrent Extrahepatic Bile Duct Cancer Recurrent Gallbladder Cancer Unresectable Extrahepatic Bile Duct Cancer Unresectable Gallbladder Cancer||Drug: erlotinib hydrochloride Biological: bevacizumab||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||56 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of Bevacizumab and Erlotinib in Patients With Advanced Biliary Tumors|
|Study Start Date :||May 2006|
|Actual Primary Completion Date :||October 2008|
|Actual Study Completion Date :||June 2010|
U.S. FDA Resources
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
- Number of Confirmed Tumor Responses. [ Time Frame: After 6 courses of treatment. Each course lasts 28 days. ]
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 ]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 ]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 ]Point estimates and 95% confidence intervals were calculated using the method of Duffy and Santner (1987).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00356889
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||William Schelman||Mayo Clinic|