NCT00601510

Imatinib, Capecitabine, and Cisplatin in Treating Patients With Unresectable or Metastatic Stomach Cancer

A Phase I Study of Capecitabine, Cisplatin and Imatinib in Patients With Unresectable or Metastatic Gastric Cancer.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Technical University of Munich · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Imatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as capecitabine and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving imatinib together with combination chemotherapy may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of imatinib when given together with capecitabine and cisplatin in treating patients with unresectable or metastatic stomach cancer.

Detailed description

OBJECTIVES: Primary * To determine the maximum tolerable dose and assess the safety and tolerability of imatinib mesylate in combination with capecitabine and cisplatin in patients with unresectable or metastatic gastric cancer. Secondary * To assess the preliminary antitumor activity of this regimen in these patients. * To assess the response with regard to the expression and/or mutation of the tyrosine kinase receptors PDGF-R and c-kit in gastric cancer. OUTLINE: This is a dose-escalation study of imatinib mesylate. Patients receive oral imatinib mesylate once daily on days -4 to 21 in course 1 and on days 1-21 in all subsequent courses, oral capecitabine twice daily on days 1-14, and cisplatin IV on day 1. Courses repeat every 3 weeks\* for 12 months in the absence of disease progression or unacceptable toxicity. NOTE: \*First course is 25 days. After completion of study therapy, patients are followed every 3 weeks.

Conditions

• Gastric Cancer

Interventions

Type	Name	Description
DRUG	capecitabine
DRUG	cisplatin
DRUG	imatinib mesylate

Timeline

• Start date: 2007-11-01
• Primary completion: 2011-01-01
• Completion: 2012-01-01
• First posted: 2008-01-28
• Last updated: 2013-03-19

Locations

1 site across 1 country: Germany