Gemcitabine and Bevacizumab in Treating Patients With Pancreatic Cancer That Has Been Completely Removed By Surgery
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. 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. Giving gemcitabine and bevacizumab after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase I/II trial is studying the side effects of gemcitabine and bevacizumab and to see how well they work in treating patients with pancreatic cancer that has been completely removed by surgery.
Drug: gemcitabine hydrochloride
Procedure: adjuvant therapy
|Study Design:||Allocation: Non-Randomized
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I/II Study of Fixed-Dose Rate Gemcitabine and Bevacizumab for Postoperative Adjuvant Treatment of Patients With Resected Pancreatic Cancer|
- Safety of gemcitabine when administered with bevacizumab as assessed by NCI CTCAE v3.0 [ Designated as safety issue: Yes ]
- Disease-free survival rate at 1 year [ Designated as safety issue: No ]
- Overall survival rate at 1 and 2 years [ Designated as safety issue: No ]
- Median disease-free survival rate at 1 and 2 years [ Designated as safety issue: No ]
- Median overall survival rate at 1 and 2 years [ Designated as safety issue: No ]
|Study Start Date:||July 2006|
|Study Completion Date:||October 2007|
|Primary Completion Date:||October 2007 (Final data collection date for primary outcome measure)|
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00410774
|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|