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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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States
Start Date
February 1, 2002
Primary Completion Date
December 1, 2004
Last Updated
January 24, 2013
50
ACTUAL participants
gemcitabine hydrochloride
DRUG
bevacizumab
BIOLOGICAL
laboratory biomarker analysis
OTHER
Lead Sponsor
National Cancer Institute (NCI)
NCT04550494
NCT05053971
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