Bevacizumab and Erlotinib in Treating Patients With Metastatic Pancreatic Cancer That Did Not Respond to Previous Treatment With Gemcitabine
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.
Drug: erlotinib hydrochloride
Other: laboratory biomarker analysis
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial of Bevacizumab Plus Erlotinib for Patients With Metastatic Gemcitabine-Refractory Pancreatic Cancer|
- Overall survival rate at 6 months [ Designated as safety issue: No ]
- Safety and toxicity [ Designated as safety issue: Yes ]
- Objective response rate as measured by RECIST criteria [ Designated as safety issue: No ]
- Time to tumor progression [ Designated as safety issue: No ]
- Proportion of patients with ≥ 50% decline in serum CA19-9 biomarker [ Designated as safety issue: No ]
|Study Start Date:||February 2006|
|Study Completion Date:||March 2010|
|Primary Completion Date:||January 2009 (Final data collection date for primary outcome measure)|
- 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.
- 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 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 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.
|United States, California|
|UCSF Helen Diller Family Comprehensive Cancer Center|
|San Francisco, California, United States, 94115|
|Study Chair:||Andrew Ko, MD||University of California, San Francisco|