Gastric Cancer Clinical Trial
Official title:
Phase II Trial of Bevacizumab, Docetaxel, and Oxaliplatin in Gastric and Gastroesophageal Junction Cancer
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different
ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and
kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of
tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as
oxaliplatin and docetaxel, work in different ways to stop the growth of tumor cells, either
by killing the cells or by stopping them from dividing. Giving bevacizumab together with
oxaliplatin and docetaxel may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving bevacizumab together with
oxaliplatin and docetaxel works in treating patients with locally advanced unresectable or
metastatic stomach or gastroesophageal junction cancer.
OBJECTIVES:
Primary
- Determine the time to progression in patients with locally advanced unresectable or
metastatic gastric or gastroesophageal junction adenocarcinoma treated with bevacizumab,
oxaliplatin, and docetaxel.
Secondary
- 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
regimen.
- 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 months.
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