Bevacizumab and Erlotinib in Treating Patients With Metastatic Pancreatic Cancer That Did Not Respond to Previous Treatment With Gemcitabine

Pancreatic Cancer Clinical Trial

Official title: A Phase II Trial of Bevacizumab Plus Erlotinib for Patients With Metastatic Gemcitabine-Refractory Pancreatic Cancer

Status Completed

Clinical Trial Summary

RATIONALE: 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. Bevacizumab may also stop the growth of pancreatic cancer by blocking blood flow to the tumor. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving bevacizumab together with erlotinib may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving bevacizumab together with erlotinib works in treating patients with metastatic pancreatic cancer that did not respond to previous treatment with gemcitabine.

Clinical Trial Description

OBJECTIVES:

Primary

• Evaluate the 6-month overall survival rate in patients with gemcitabine hydrochloride-refractory metastatic pancreatic cancer treated with bevacizumab and erlotinib hydrochloride.

• Determine the safety and toxicity of this regimen in these patients.

Secondary

• Evaluate the objective response rate in these patients.

• Evaluate time to tumor progression in these patients.

• Determine the efficacy of this regimen, in terms of the proportion of patients with ≥ 50% decline in carbohydrate antigen 19-9, also called cancer antigen 19-9 (CA19-9) biomarker, in these patients.

• Obtain sequential measurements of circulating tumor cells (micrometastases) and endothelial cells in serum and correlate these variables with clinical outcomes (in patients enrolled in UCSF site only).

OUTLINE: This is an open-label, nonrandomized, multicenter study.

Patients receive bevacizumab IV over 30-90 minutes on day 1 and oral erlotinib hydrochloride once daily on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

Patients undergo blood collection at baseline and periodically during study for biomarker/laboratory analysis, including the CA19-9 biomarker. Circulating tumor micrometastases and endothelial cells are also measured in patients enrolled in University of California San Francisco (UCSF) site.

After completion of study treatment, patients are followed at 30 days and at 6 months.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study. ;

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

• NCT number: NCT00365144
• Study type: Interventional
• Source: University of California, San Francisco
• Status: Completed
• Phase: Phase 2
• Start date: February 2006
• Completion date: March 2010