Irinotecan in Treating Patients With Advanced Solid Tumors
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of irinotecan in treating patients who have advanced solid tumors.
|Unspecified Adult Solid Tumor, Protocol Specific||Drug: irinotecan hydrochloride||Phase 1|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||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|
|Study Start Date:||August 1998|
|Study Completion Date:||December 2009|
|Primary Completion Date:||July 2001 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004051
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Study Chair:||Leonard B. Saltz, MD||Memorial Sloan Kettering Cancer Center|