A Phase II Trial Of Bevacizumab (NSC#704865) Plus Gemcitabine In Patients With Advanced Pancreatic Cancer
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.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective response rate (complete or partial responses)
Up to 2 years
No
Hedy Kindler
Principal Investigator
University of Chicago Comprehensive Cancer Center
United States: Food and Drug Administration
NCI-2012-02440
NCT00028834
February 2002
Name | Location |
---|---|
University of Chicago Comprehensive Cancer Center | Chicago, Illinois 60637-1470 |