This phase II trial is studying how well giving irinotecan and cisplatin together with bevacizumab works in treating patients with unresectable or metastatic gastric (stomach) or gastroesophageal junction adenocarcinoma (cancer). Drugs used in chemotherapy, such as irinotecan and cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as bevacizumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Giving chemotherapy together with a monoclonal antibody may kill more tumor cells.
PRIMARY OBJECTIVES: I. Determine the efficacy of irinotecan, cisplatin, and bevacizumab, in terms of time to progression, in patients with unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma. SECONDARY OBJECTIVES: I. Determine other measures of efficacy, including response rate and median and 1-year survival, in patients treated with this regimen. II. Determine the toxicity of this regimen in these patients. III. Correlate CT perfusion imaging results with the efficacy of this regimen, in terms of time to progression, objective response, and survival, in these patients. IV. Determine the feasibility of serial serum proteomic assays in predicting response to therapy, in terms of time to progression, objective response, and survival, in patients treated with this regimen. V. To bank paraffin stored tumor biopsy material for future planned immunohistochemistry studies to correlate with sensitivity to bevacizumab based combination chemotherapy. OUTLINE: This is an open-label, non-randomized, multicenter study. Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive cisplatin IV over 30 minutes followed by irinotecan IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 1 year.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
47
Given IV
Given IV
Given IV
Correlative studies
Correlative studies
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Time to progression, evaluated using RECIST
Kaplan-Meier estimates will be used.
Time frame: Up to 1 year
Overall response rate, evaluated using RECIST
95% exact binomial confidence intervals will be used to describe the distribution.
Time frame: Up to 1 year
Complete response rate, evaluated using RECIST
95% exact binomial confidence intervals will be used to describe the distribution.
Time frame: Up to 1 year
Duration of response, evaluated using RECIST
Time frame: From the time measurement criteria are met for CR/PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 1 year
Survival
Kaplan-Meier estimates will be used.
Time frame: Up to 1 year
Incidence of toxicity, evaluated using CTCAE version 3.0
Time frame: Up to 1 year
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