Amifostine Plus Irinotecan in Treating Patients With Metastatic Colorectal Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00003225|
Recruitment Status : Completed
First Posted : July 21, 2004
Last Update Posted : October 2, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Drug: amifostine trihydrate Drug: irinotecan hydrochloride||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||23 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I/II Trial to Evaluate Ethyol as a Protective Agent for Irinotecan (CPT-11) Toxicities in Patients With Advanced Colorectal Cancer|
|Study Start Date :||July 1997|
|Primary Completion Date :||March 2000|
|Study Completion Date :||June 2001|
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
- To assess the toxicity profile of Irinotecan and Ethyol when administered together on this schedule. [ Time Frame: 12 weeks ]
- To assess the total dose of Irinotecan received per 6 week cycle [ Time Frame: 6 weeks ]
- To determine incidence of Irinotecan-induced leukopenia and neutropenia [ Time Frame: 12 weeks ]
- To determine the incidence of Irinotecan-induced diarrhea [ Time Frame: 12 weeks ]
- 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 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|