Phase II Trial of Bevacizumab, Docetaxel, and Oxaliplatin in Gastric and Gastroesophageal Junction Cancer
- Determine the time to progression in patients with locally advanced unresectable or
metastatic gastric or gastroesophageal junction adenocarcinoma treated with
bevacizumab, oxaliplatin, and docetaxel.
- Determine the response rate in patients treated with this regimen.
- Determine the toxic effects of this regimen in these patients.
- Determine time to treatment failure and overall survival of patients treated with this
- Determine the changes in general and disease-specific quality of life, in terms of
response to treatment, in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive bevacizumab IV over 30-90 minutes, oxaliplatin IV over 120 minutes, and
docetaxel IV over 60 minutes on day 1. Courses repeat every 21 days in the absence of
disease progression or unacceptable toxicity. Patients achieving a complete response (CR)
receive 2 additional courses beyond CR.
After completion of study treatment, patients are followed periodically for up to 2 years.
PROJECTED ACCRUAL: A total of 38 patients will be accrued for this study within 18-23
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Time to progression
After every 2 cycles (1 cycle =21 days)
Philip A. Philip, MD, PhD, FRCP
Barbara Ann Karmanos Cancer Institute
United States: Federal Government
|University of Michigan Comprehensive Cancer Center||Ann Arbor, Michigan 48109-0752|
|Barbara Ann Karmanos Cancer Institute||Detroit, Michigan 48201|
|Veterans Affairs Medical Center - Detroit||Detroit, Michigan 48201-1932|
|Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center||Columbus, Ohio 43210-1240|