Amifostine Plus Irinotecan in Treating Patients With Metastatic Colorectal Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase I/II trial to study the effectiveness of amifostine plus irinotecan in treating patients with metastatic colorectal cancer.
Drug: amifostine trihydrate
Drug: irinotecan hydrochloride
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I/II Trial to Evaluate Ethyol as a Protective Agent for Irinotecan (CPT-11) Toxicities in Patients With Advanced Colorectal Cancer|
- To assess the toxicity profile of Irinotecan and Ethyol when administered together on this schedule. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
- To assess the total dose of Irinotecan received per 6 week cycle [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- To determine incidence of Irinotecan-induced leukopenia and neutropenia [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
- To determine the incidence of Irinotecan-induced diarrhea [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
- To determine the response rate for patients with metastatic colorectal carcinoma receiving Irinotecan and Ethyol on this dosing schedule (as measured by time response, duration of response time to progression, time of treatment failure survival). [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- To determine the clinical benefit of intravenous Irinotecan and Ethyol in patients with colorectal cancer, as measured by performance status, analgesic consumption, quality of life and survival. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||July 1997|
|Study Completion Date:||June 2001|
|Primary Completion Date:||March 2000 (Final data collection date for primary outcome measure)|
Experimental: Ethyol plus Irinotecan
Ethyol 740 mg/m2 will be administered intravenously over 10 minutes. 10 minutes after completion of the Ethyol infusion, Irinotecan 250 mg/m2 will be given over 90 minutes IV.
Drug: amifostine trihydrate
Ethyol 740 mg/m2 will be administered intravenously over 10 minutes. Administered every two weeks for 3 cycles.
Other Name: EthyolDrug: irinotecan hydrochloride
10 minutes after completion of the Ethyol infusion, Irinotecan 250 mg/m2 will be given over 90 minutes IV.
Administered every 14 days for 3 cycles
OBJECTIVES: I. Assess the toxicity profile of irinotecan and amifostine when administered together in patients with metastatic colorectal cancer. II. Assess the total dose of irinotecan received per 6 week course in these patients. III. Determine the incidence of irinotecan-induced leukopenia, neutropenia, and diarrhea in these patients. V. Determine the response rate for this patient population.
OUTLINE: This is an open label study. Amifostine is administered by 10 minute IV infusions. Irinotecan is administered by IV infusions 15 minutes after completion of amifostine. Treatment is repeated every 2 weeks for 6 weeks. This 6 week course is repeated in the absence of disease progression. Treatment may be delayed up to 2 weeks after a course to allow for recovery from toxic effects. Patients are followed at the end of study and at 30 days after study.
PROJECTED ACCRUAL: There will be 25-30 patients accrued into this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003225
|United States, California|
|Jonsson Comprehensive Cancer Center, UCLA|
|Los Angeles, California, United States, 90095-1781|
|Wilshire Oncology Medical Group, Inc.|
|Rancho Cucamonga, California, United States, 91730|
|Study Chair:||Diane Prager, MD||Jonsson Comprehensive Cancer Center|