Pancreatic Cancer Clinical Trial
Official title:
Phase II Trial of Bevacizumab, Gemcitabine, Oxaliplatin in Patients With Metastatic Pancreatic Adenocarcinoma
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.
OBJECTIVES:
Primary
- Determine the 6-month survival of patients with metastatic adenocarcinoma of the
pancreas treated with bevacizumab, gemcitabine, and oxaliplatin.
Secondary
- 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.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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