Combination Chemotherapy in Treating Patients With Colorectal Cancer

Sponsor
Alliance for Clinical Trials in Oncology
Study ID
NCT00006103
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if the effectiveness of irinotecan combined with fluorouracil in treating colorectal cancer varies depending on the patient's racial background. PURPOSE: Phase III trial to study the effectiveness of irinotecan combined with fluorouracil in treating patients from different racial backgrounds who have colorectal cancer that is advanced, recurrent, metastatic or has not responded to treatment with fluorouracil.

Key Dates

Start date
Jul 31, 2000
Status verified
Jul 2016
Primary completion
Apr 30, 2002
Completion
Apr 30, 2002

Study Design

Enrollment
400 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: irinotecan + leucovorin + fluorouracil
    Patients receive irinotecan IV over 90 minutes, leucovorin calcium IV, and fluorouracil IV on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for a total of 5 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 1 year and then every 6 months thereafter.

Primary Outcome Measure

overall survival [ Time Frame: Up to 10 years ]

Related Studies