NCT00253565

Imatinib Mesylate and Capecitabine in Treating Patients With Advanced Solid Tumors

A Phase I Dose Escalation Study of Imatinib Mesylate (Gleevec/STI571) Plus Capecitabine (Xeloda) in Advanced Solid Tumor Malignancies

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Herbert Hurwitz · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

OBJECTIVES: Primary * Determine the maximum tolerated dose and recommended phase II dose of imatinib mesylate when administered with capecitabine in patients with advanced malignant solid tumors. Secondary * Determine the non-dose-limiting toxic effects of this regimen in these patients. * Determine, preliminarily, the clinical activity of this regimen in these patients. * Determine the pharmacokinetics and pharmacogenetics of this regimen in these patients. * Determine, preliminarily, the effect of this regimen on wound angiogenesis in these patients. * Correlate pharmacokinetic parameters with clinical toxicity, clinical activity, or surrogate biomarker activity of this regimen in these patients. OUTLINE: This is a dose escalation study of imatinib mesylate. Patients receive oral capecitabine twice daily on days 1-14 and oral imatinib mesylate once or twice daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of patients receive escalating doses of imatinib mesylate until the maximum tolerated dose is determined. PROJECTED ACCRUAL: A total of 42 patients will be accrued for this study.

Conditions

• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
DRUG	capecitabine
DRUG	imatinib mesylate

Timeline

• Start date: 2003-08-01
• Primary completion: 2006-07-01
• Completion: 2010-07-01
• First posted: 2005-11-15
• Last updated: 2013-04-08

Locations

1 site across 1 country: United States