A Multicenter, Open-Label, Phase II Study of Irinotecan, Cisplatin, and Bevacizumab in Patients With Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
I. Determine the efficacy of irinotecan, cisplatin, and bevacizumab, in terms of time to
progression, in patients with unresectable or metastatic gastric or gastroesophageal
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.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Time to progression, evaluated using RECIST
Kaplan-Meier estimates will be used.
Up to 1 year
Memorial Sloan-Kettering Cancer Center
United States: Food and Drug Administration
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|