A Phase I Study of Continuous Oral Administration of SCH 66336 and 5-Fluorouracil/Leucovorin (5FU/LV) in Patients With Advanced Cancer
OBJECTIVES: I. Determine the safety, tolerability, maximum tolerated dose, and dose limiting
toxicity of oral SCH 66336 with fluorouracil and leucovorin calcium in patients with
advanced malignancy. II. Assess the multiple dose pharmacokinetics of oral SCH 66336 when
administered with fluorouracil and leucovorin calcium. III. Assess the pharmacokinetics of
fluorouracil when administered with oral SCH 66336. IV. Assess antitumor activity of oral
SCH 66336 with fluorouracil and leucovorin calcium in these patients.
OUTLINE: This is a dose escalation study of SCH 66336. Patients receive oral SCH 66336 twice
daily for 56 days. Patients receive leucovorin calcium IV over 1-2 minutes immediately
followed by fluorouracil IV over 1-2 minutes on days 1, 8, 15, 22, 29, and 36. Courses
repeat every 56 days in the absence of disease progression or unacceptable toxicity. Cohorts
of 3-6 patients receive escalating doses of SCH 66336. The maximum tolerated dose is defined
as the dose at which no more than 1 of 6 patients experiences dose limiting toxicity (DLT)
during course 1, with at least 2 patients experiencing DLT at the next higher level.
PROJECTED ACCRUAL: Approximately 25 patients will be accrued for this study.
Primary Purpose: Treatment
Leonard B. Saltz, MD
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|