Phase I Study Of Oral Etoposide In Combination With ORZEL (UFT + Leucovorin) For Advanced Non-Hematological Malignancies
OBJECTIVES: I. Determine the maximum tolerated dose of etoposide when combined with fixed-
dose fluorouracil-uracil plus leucovorin calcium in patients with advanced solid tumors. II.
Determine possible side effects and toxicity of this regimen in these patients.
OUTLINE: This is a dose escalation study of etoposide. Patients receive oral etoposide daily
on days 1-10 and oral fluorouracil-uracil plus oral leucovorin calcium twice a day on days
1-21. Treatment repeats every 28 days for a maximum of 6 courses in the absence of
unacceptable toxicity or disease progression. Cohorts of 3-6 patients receive escalating
doses of etoposide until the maximum tolerated dose (MTD) is determined. The MTD is defined
as the dose preceding that at which 2 or more of 6 patients experience dose-limiting
toxicity. Patients are followed at 2 months and then periodically 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|