The purpose of this study is to find out if giving patients bevacizumab along with the chemotherapy drugs oxaliplatin and gemcitabine will improve overall survival. In addition, the study will find out what side effects patients may have by taking bevacizumab, oxaliplatin, and gemcitabine together.
Design: * A phase II single arm study. All patients receive bevacizumab 10mg/kg and gemcitabine 1000mg/m2 on day 1 followed by oxaliplatin 100mg/m2 on day 2 of a 14 day cycle. Purpose: * The purpose of this study is to find out if giving patients bevacizumab, along with the chemotherapy drugs oxaliplatin and gemcitabine, will improve overall survival. In addition, the study will find out what side effects patients may have by taking bevacizumab, oxaliplatin and gemcitabine together. Enrollment: * Approximately 30 patients will be enrolled to the study between the University of Oklahoma and M.D. Anderson Cancer Center. Duration: * The study will be conducted over approximately 2 years.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
50
10mg/kg IV on Day 1 Q 2 weeks
1000mg/m2 as fixed-rate infusion at 10mg/m2/min on Day 1 and Q 2 weeks.
100mg/m2 on Day 2 and Q 2 weeks.
University of Oklahoma
Oklahoma City, Oklahoma, United States
MD Anderson Cancer Center
Houston, Texas, United States
To determine the overall survival (OS) rate at 1 year in this patient population, treated with the combination therapy of bevacizumab plus gemcitabine and oxaliplatin
Time frame: One year
To determine the objective tumor response rate in this patient population. To determine time to progression (TTP) and progression free survival (PFS) in this patient population
Time frame: One year
To determine the tolerability and toxicity profile of this regimen in this patient population
Time frame: One year
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