A Phase I Dose Escalation Study of Imatinib Mesylate (Gleevec/STI571) Plus Capecitabine (Xeloda) in Advanced Solid Tumor Malignancies
- Determine the maximum tolerated dose and recommended phase II dose of imatinib mesylate
when administered with capecitabine in patients with advanced malignant solid tumors.
- 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
- 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.
Primary Purpose: Treatment
Herbert I. Hurwitz, MD
Duke Cancer Institute
United States: Food and Drug Administration
|Duke Comprehensive Cancer Center||Durham, North Carolina 27710|