Stage IV Gastric Cancer Clinical Trial
Official title:
A Phase II Trial of STI571 in the Treatment of Metastatic Gastric Cancer
Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. This phase II trial is studying how well imatinib mesylate works in treating patients with refractory metastatic and/or unresectable stomach or gastroesophageal junction cancer.
PRIMARY OBJECTIVES:
I. To determine the response rate, time to tumor progression, and overall survival in
patients with metastatic gastric cancer treated with STI571 who have failed one chemotherapy
regimen for metastatic disease.
II. To assess the toxicities of STI571 in these patients. III. To obtain preliminary data on
molecular correlates to determine clinical efficacy and toxicity.
OUTLINE: This is a multicenter study. Patients are stratified according to risk (good risk
[chemonaïve] vs poor risk [1 prior chemotherapy regimen]).
Patients receive oral imatinib mesylate twice daily on days 1-28. Courses repeat every 4
weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed for 30 days.
PROJECTED ACCRUAL: A total of 21-41 patients will be accrued for this study within 1-1.5
years.
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