A Phase I/II Study of Fixed-Dose Rate Gemcitabine and Bevacizumab for Postoperative Adjuvant Treatment of Patients With Resected Pancreatic Cancer
OBJECTIVES:
Primary
- Determine the safety of adjuvant, fixed-dose rate gemcitabine hydrochloride and
bevacizumab in patients with completely resected pancreatic cancer.
- Determine the 1-year disease-free survival rate in patients treated with this regimen.
Secondary
- Determine the 1- and 2-year overall survival rates in these patients.
- Determine the median disease-free survival rate in these patients.
- Determine the median overall survival rate in these patients.
OUTLINE: This is an open-label, non-randomized study.
Patients receive gemcitabine hydrochloride IV over 100 minutes followed by bevacizumab* IV
over 30-90 minutes on days 1 and 15. Treatment repeats every 28 days for up to 6 courses in
the absence of disease recurrence or unacceptable toxicity.
NOTE: *The first dose of bevacizumab is not administered until after 6 weeks have passed
since surgery.
After completion of study therapy, patients are followed periodically for 18 months.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
Interventional
Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment
Safety of gemcitabine when administered with bevacizumab as assessed by NCI CTCAE v3.0
Yes
Andrew Ko, MD
Study Chair
University of California, San Francisco
United States: Food and Drug Administration
CDR0000517330
NCT00410774
July 2006
October 2007
Name | Location |
---|---|
UCSF Helen Diller Family Comprehensive Cancer Center | San Francisco, California 94115 |