Paclitaxel Combined With Fluorouracil-Uracil and Leucovorin in Treating Patients With Solid Tumors
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of paclitaxel combined with fluorouracil-uracil and leucovorin in treating patients who have solid tumors.
|Unspecified Adult Solid Tumor, Protocol Specific||Drug: leucovorin calcium Drug: paclitaxel Drug: tegafur-uracil||Phase 1|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase I Study Of Weekly Paclitaxel In Combination With ORZEL (UFT + Leucovorin) For Advanced Non-Hematological Malignancies|
|Study Start Date:||December 1999|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00009828
|Study Chair:||Chandra P. Belani, MD||University of Pittsburgh|