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 — DRUG
    Ethyol 740 mg/m2 will be administered intravenously over 10 minutes. Administered every two weeks for 3 cycles.
  • irinotecan hydrochloride — DRUG
    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

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 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.

Primary Outcome Measure

To assess the toxicity profile of Irinotecan and Ethyol when administered together on this schedule. [ Time Frame: 12 weeks ]

Locations (2)

FacilityCityStateZIPSite coordinators
Jonsson Comprehensive Cancer Center, UCLALos AngelesCalifornia90095-1781-
Wilshire Oncology Medical Group, Inc.Rancho CucamongaCalifornia91730-

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