NCT00356889

Bevacizumab and Erlotinib Hydrochloride in Treating Patients With Metastatic or Unresectable Biliary Tumors

A Phase II Trial of Bevacizumab and Erlotinib in Patients With Advanced Biliary Tumors

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• 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

Interventions

Type	Name	Description
DRUG	erlotinib hydrochloride	Given orally, 150 mg, once daily.
BIOLOGICAL	bevacizumab	Given IV, 5mg/kg on days 1 and 15 every cycle

Timeline

• Start date: 2006-05-01
• Primary completion: 2008-10-01
• Completion: 2010-06-01
• First posted: 2006-07-27
• Last updated: 2014-05-28
• Results posted: 2013-05-20

Locations

1 site across 1 country: United States