NCT00068380

A Phase II Trial of STI571 in the Treatment of Metastatic Gastric Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Recurrent Gastric Cancer
• Stage IV Gastric Cancer

Interventions

Type	Name	Description
DRUG	imatinib mesylate	Given orally
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2004-03-01
• Primary completion: 2010-03-01
• Completion: 2010-03-01
• First posted: 2003-09-11
• Last updated: 2018-07-11
• Results posted: 2014-08-12

Locations

1 site across 1 country: United States