Amifostine Plus Irinotecan in Treating Patients With Metastatic Colorectal Cancer
Part of paid clinical trials in Los Angeles, California.
- Sponsor
- Jonsson Comprehensive Cancer Center
- Study ID
- NCT00003225
- Phase
- PHASE1/PHASE2
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- amifostine trihydrate — DRUGEthyol 740 mg/m2 will be administered intravenously over 10 minutes. Administered every two weeks for 3 cycles.
- irinotecan hydrochloride — DRUG10 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
Study Details
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.
Key Dates
- Start date
- Jul 31, 1997
- Status verified
- Jul 2012
- Primary completion
- Mar 31, 2000
- Completion
- Jun 30, 2001
Study Design
- Enrollment
- 23 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Ethyol plus IrinotecanEthyol 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.
Primary Outcome Measure
To assess the toxicity profile of Irinotecan and Ethyol when administered together on this schedule. [ Time Frame: 12 weeks ]
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Jonsson Comprehensive Cancer Center, UCLA | Los Angeles | California | 90095-1781 | - |
| Wilshire Oncology Medical Group, Inc. | Rancho Cucamonga | California | 91730 | - |
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