Combination Chemotherapy in Treating Patients With Recurrent or Metastatic Colorectal Cancer

Phase 3

Completed

• Conditions: Colorectal Cancer

• Registration Number: NCT00003287
• 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. Combining more than one drug may kill more tumor cells. It is not yet known which regimen of combination chemotherapy is more effective in treating patients with recurrent or metastatic colorectal cancer.

PURPOSE: Randomized phase III trial to study the effectiveness of combining fluorouracil, leucovorin, and oxaliplatin in different ways in treating patients with recurrent or metastatic colorectal cancer.

Detailed Description

OBJECTIVES: I. Compare the effects of chronomodulated versus nonchronomodulated infusional administration of a 3 drug high-dose chemotherapy regimen on survival in patients with locoregionally recurrent or metastatic colorectal cancer. II. Assess the antitumor effect of the combination of fluorouracil, leucovorin calcium, and oxaliplatin given as first line chemotherapy in these patients. III. Assess the response rate and toxicity of this treatment in these patients. IV. Assess the quality of life of patients receiving this treatment.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to performance status (ECOG 0-1 vs 2), extent of liver involvement (none vs less than 25% vs 25% or greater), and institution. Patients are randomized into 2 arms: Arm I (chronotherapy): Patients receive a 4 day infusion of fluorouracil, leucovorin calcium, and oxaliplatin administered via pump using chronomodulated delivery rates. Arm II (fixed infusion rate): Patients receive leucovorin calcium and oxaliplatin as 2 hour concurrent infusions followed by fluorouracil as a 22 hour infusion on day 1. On day 2, patients receive a 2 hour infusion of leucovorin calcium followed by a 22 hour infusion of fluorouracil. For patients on both arms, courses repeat every 2 weeks until the occurrence of disease progression, severe toxicity, or complete remission for a minimum of 4 months. Quality of life is assessed prior to treatment and 2 weeks after courses 4 and 8. Patients are followed for survival.

PROJECTED ACCRUAL: A total of 554 patients will be accrued for this study.

Study Timeline

• Study Start: 1998-03
• Study First Submitted: 1999-11-01
• Primary Completion: 2002-03
• Study First Submitted QC: 2004-01-22
• Study First Posted: 2004-01-23
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-29
• Last Update Posted: 2012-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 554

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (36)

Krankenanstalt Rudolfstiftung; 🇦🇹 Vienna (Wien), Austria

VZW Monica Campus Eewnfeestkliniek; 🇧🇪 Antwerpen, Belgium

Cliniques Universitaires Saint-Luc; 🇧🇪 Brussels (Bruxelles), Belgium

Hopital Saint Jean; 🇧🇪 Brussels, Belgium

Centre Hospitalier Notre Dame - Reine Fabiola; 🇧🇪 Charleroi, Belgium

Les Cliniques Saint-Joseph ASBL; 🇧🇪 Liege (Luik), Belgium

CHU Sart-Tilman; 🇧🇪 Liege, Belgium

Clinique Sainte Elisabeth; 🇧🇪 Namur, Belgium

Centre Hospitalier de Lorraine; 🇧🇪 Virton, Belgium

Sunnybrook and Women's College Health Sciences Centre; 🇨🇦 North York, Ontario, Canada

Scroll for more (26 remaining)