Stage IV Pancreatic Cancer Clinical Trial
Official title:
A Phase II Trial Of Bevacizumab (NSC#704865) Plus Gemcitabine In Patients With Advanced Pancreatic Cancer
This phase II trial is to see if combining gemcitabine with bevacizumab works in treating patients who have advanced pancreatic cancer. Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them. Combining chemotherapy with a monoclonal antibody may kill more tumor cells
PRIMARY OBJECTIVES:
I. To determine the objective response rate of patients with advanced pancreatic cancer who
are treated with gemcitabine plus bevacizumab.
II. To determine the toxicity experienced by patients with advanced pancreatic cancer who
are treated with gemcitabine plus bevacizumab.
III. To determine median and overall survival of patients with advanced pancreatic cancer
who are treated with gemcitabine plus bevacizumab.
SECONDARY OBJECTIVES:
I. To measure plasma VEGF and serum VCAM-1 levels before, during, and after therapy as a
predictor of outcome.
II. To collect and store serum samples for possible future assessment of other
antiangiogenic inhibition markers.
OUTLINE: This is a multicenter study.
Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15 and bevacizumab IV over
30-90 minutes on days 1 and 15. Treatment repeats every 28 days in the absence of disease
progression or unacceptable toxicity.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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