Phase I Study Of Weekly Paclitaxel In Combination With ORZEL (UFT + Leucovorin) For Advanced Non-Hematological Malignancies
OBJECTIVES: I. Determine the maximum tolerated dose of weekly paclitaxel when combined with
fluorouracil-uracil and leucovorin calcium in patients with solid tumors. II. Determine the
side effects and toxicity of this regimen in these patients.
OUTLINE: This is a dose escalation study of paclitaxel. Patients receive paclitaxel IV on
days 1, 8, and 15. Patients also receive oral fluorouracil-uracil and leucovorin calcium
twice daily on days 2-6, 9-13, and 16-20. Treatment repeats every 4 weeks for up to 6
courses in the absence of progressive disease or unacceptable toxicity. Cohorts of 3-6
patients receive escalating doses of paclitaxel until the maximum tolerated dose (MTD) is
determined. The MTD is defined as the dose at which at least 2 of 6 patients experience
dose-limiting toxicity. Patients are followed at 2 months and then for survival.
PROJECTED ACCRUAL: Approximately 25-30 patients will be accrued for this study.
Primary Purpose: Treatment
Chandra P. Belani, MD
University of Pittsburgh
United States: Federal Government
|University of Pittsburgh Cancer Institute||Pittsburgh, Pennsylvania 15213|