Fluorouracil and Leucovorin With or Without Irinotecan in Treating Patients With Metastatic Colorectal Cancer

Phase 3

Completed

• Conditions: Colorectal Cancer

• Registration Number: NCT00004885
• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

Brief Summary

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 whether fluorouracil and leucovorin plus irinotecan is more effective than fluorouracil and leucovorin alone for colorectal cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of fluorouracil and leucovorin with or without irinotecan in treating patients who have metastatic colorectal cancer.

Detailed Description

OBJECTIVES: I. Compare the efficacy and toxicity of high-dose fluorouracil and leucovorin calcium with or without irinotecan in patients with metastatic adenocarcinoma of the colon or rectum. II. Compare progression-free survival, overall survival, response rate, and duration of response in patients treated with these 2 regimens. III. Compare quality of life of patients treated with these 2 regimens.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two treatment arms. Arm I: Patients receive leucovorin calcium IV over 2 hours followed by fluorouracil IV over 24 hours on days 1, 8, 15, 22, 29, and 36. Arm II: Patients receive irinotecan IV over 30 minutes followed by leucovorin calcium IV over 2 hours and fluorouracil IV over 24 hours on days 1, 8, 15, 22, 29, and 36. Treatment in both arms repeats every 7 weeks in the absence of disease progression or unacceptable toxicity. Patients in arm I who develop disease progression begin second-line therapy comprising irinotecan, fluorouracil, and leucovorin calcium within 2 months of progression. Patients with complete response are taken off study after receiving treatment for one year. Quality of life is assessed before beginning study, after completion of each course, at 4 weeks after completion of study, and then every 2 months until disease progression or death. Patients are followed every 2 months until disease progression or death.

PROJECTED ACCRUAL: A total of 430 patients (215 per arm) will be accrued for this study within 2 years.

Study Timeline

• Study Start: 1999-07
• Study First Submitted: 2000-03-07
• Primary Completion: 2001-07
• Study First Submitted QC: 2004-04-09
• Study First Posted: 2004-04-12
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-20
• Last Update Posted: 2012-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 430

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (57)

Allgemeines Krankenhaus der Stadt Wien; 🇦🇹 Vienna, Austria

U.Z. Gasthuisberg; 🇧🇪 Leuven, Belgium

National Cancer Institute of Egypt; 🇪🇬 Cairo, Egypt

Institut Gustave Roussy; 🇫🇷 Villejuif, France

PZB - Praxenzentrum; 🇩🇪 Aachen, Germany

Kreiskrankenhaus Aurich; 🇩🇪 Aurich, Germany

Haematology-Oncology; 🇩🇪 Braunschweig, Germany

Humaine Klinik Dresden GmbH; 🇩🇪 Dresden, Germany

Medizinische Klinik I; 🇩🇪 Dresden, Germany

Universitaetsklinik Duesseldorf; 🇩🇪 Duesseldorf, Germany

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