Irinotecan and Paclitaxel in Treating Patients With Metastatic or Recurrent Cancer
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 irinotecan and paclitaxel in treating patients with metastatic or recurrent cancer.
Unspecified Adult Solid Tumor, Protocol Specific
Drug: irinotecan hydrochloride
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Trial of Dose Escalated Irinotecan (CPT-11) With Paclitaxel in Patients With Metastatic or Recurrent Malignancies|
- Determine the maximum tolerated dose [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]Determine the maximum tolerated dose of irinotecan administered on a weekly schedule with fixed-dose weekly paclitaxel.
|Study Start Date:||November 1996|
|Study Completion Date:||April 2002|
|Primary Completion Date:||February 2001 (Final data collection date for primary outcome measure)|
Experimental: Paclitaxel in combination with Irinotecan
The first study cohort will receive 60 mg/m2 of paclitaxel on cycle days 1, 8, and 15 as a 1 hr infusion. Immediately following paclitaxel, 30 mg/m2 irinotecan will be administered as a 90 minute intravenous infusion. Irinotecan doses will be administered in an identical infusion schedule on days 8 and 15 of each treatment cycle.
|Drug: irinotecan hydrochloride Drug: paclitaxel|
OBJECTIVES: I. Determine the maximum tolerated dose (MTD) of irinotecan administered in combination with paclitaxel in patients with metastatic or recurrent malignancies. II. Evaluate the toxicity and safety of this combination regimen in this patient population. III. Determine the pharmacokinetic profile of irinotecan in combination with paclitaxel on a weekly schedule and if the sequence of administration influences irinotecan pharmacokinetics in these patients. IV. Determine pharmacodynamic models of irinotecan and its SN-38 and SN-38G metabolites when administered in this weekly combination schedule.
OUTLINE: This is a dose escalation study of irinotecan. Patients receive irinotecan IV concurrently with paclitaxel IV weekly. Patients demonstrating stable disease or partial or complete clinical response continue with treatment as long as dose limiting toxicities are not observed and adequate performance status is maintained. Cohorts of 3 patients receive escalating doses of irinotecan until the maximum tolerated dose is determined or 150 mg/m2 is reached.
PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.
|United States, Illinois|
|University of Chicago Cancer Research Center|
|Chicago, Illinois, United States, 60637|
|Study Chair:||Hedy L. Kindler, MD||University of Chicago|