A Phase I Study to Evaluate Orally Administered Irinotecan HCL (CPT-11) Given as a Powder-Filled Capsule Formulation Daily for 14 Days Every Three Weeks in Patients With Advanced Solid Tumors
OBJECTIVES: I. Determine the maximum tolerated dose, dose limiting toxicity, and safety
profile of oral irinotecan in patients with advanced solid tumors. II. Characterize the
single and multiple dose pharmacokinetics of oral irinotecan and its metabolites, SN-38 and
SN-38 glucuronide, in these patients. III. Document any antitumor activity in these patients
treated with this regimen.
OUTLINE: This is a dose escalation study. Patients receive oral irinotecan once daily for 14
days. Courses repeat every 3 weeks in the absence of disease progression or unacceptable
toxicity. Cohorts of 3-6 patients receive escalating doses of irinotecan 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 monthly for 6
months.
PROJECTED ACCRUAL: Approximately 3-40 patients will be accrued for this study.
Interventional
Primary Purpose: Treatment
Leonard B. Saltz, MD
Study Chair
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
CDR0000067246
NCT00004051
August 1998
Name | Location |
---|---|
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |