Bevacizumab, Gemcitabine, and Oxaliplatin in Treating Patients With Metastatic Pancreatic Cancer
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. Drugs used in chemotherapy, such as gemcitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab together with gemcitabine and oxaliplatin may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving bevacizumab together with gemcitabine and oxaliplatin works in treating patients with metastatic pancreatic cancer.
Drug: gemcitabine hydrochloride
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of Bevacizumab, Gemcitabine, Oxaliplatin in Patients With Metastatic Pancreatic Adenocarcinoma|
- Survival at 6 months [ Designated as safety issue: No ]
- Objective response rate as measured by RECIST criteria [ Designated as safety issue: No ]
- Median survival [ Designated as safety issue: No ]
- Progression-free survival [ Designated as safety issue: No ]
- Time to treatment failure [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
- Toxicity [ Designated as safety issue: Yes ]
|Study Start Date:||June 2005|
|Primary Completion Date:||November 2010 (Final data collection date for primary outcome measure)|
- Determine the 6-month survival of patients with metastatic adenocarcinoma of the pancreas treated with bevacizumab, gemcitabine, and oxaliplatin.
- Determine the objective response rate in patients with measurable disease treated with this regimen.
- Determine median survival, progression-free survival, time to treatment failure, and overall survival of patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive gemcitabine IV over 100 minutes and bevacizumab IV over 30-90 minutes on days 1 and 15. Patients also receive oxaliplatin IV over 120 minutes on days 2 and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 2 courses of therapy beyond CR.
After completion of study treatment, patients are followed every 3-6 months for up to 5 years.
PROJECTED ACCRUAL: A total of 83 patients will be accrued for this study within 9 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00112528
Show 201 Study Locations
|Study Chair:||George P. Kim, MD||Mayo Clinic|
|Investigator:||Anthony J. Jaslowski, MD, FACP||CCOP - St. Vincent Hospital Cancer Center, Green Bay|