A Phase II Trial of Bevacizumab Plus Erlotinib for Patients With Metastatic Gemcitabine-Refractory Pancreatic Cancer
- Evaluate the 6-month overall survival rate in patients with gemcitabine
hydrochloride-refractory metastatic pancreatic cancer treated with bevacizumab and
- 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.
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall survival rate at 6 months
Andrew Ko, MD
University of California, San Francisco
United States: Food and Drug Administration
|UCSF Helen Diller Family Comprehensive Cancer Center||San Francisco, California 94115|