Comparison of Combination Chemotherapy Regimens in Treating Patients With Metastatic Colorectal Cancer

Phase 2

Completed

• Conditions: Colorectal Cancer

• Registration Number: NCT00066274
• Lead Sponsor: UNICANCER

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving the drugs in different combinations may kill more tumor cells.

PURPOSE: This randomized phase II trial is studying combination chemotherapy containing irinotecan and oxaliplatin to see how well it works compared to two standard combination chemotherapy regimens in treating patients with unresectable metastatic colorectal cancer.

Detailed Description

OBJECTIVES:

* Compare the efficacy, in terms of response rate (partial response and complete response), of irinotecan and oxaliplatin vs irinotecan, fluorouracil, and leucovorin calcium vs oxaliplatin, fluorouracil, and leucovorin calcium in patients with metastatic colorectal cancer.

* Compare the progression-free survival of patients treated with these regimens.

* Compare the tolerability of these regimens in these patients.

* Compare the quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 3 treatment arms.

* Arm I: Patients receive irinotecan IV over 90 minutes and oxaliplatin IV over 2 hours on day 1.

* Arm II: Patients receive irinotecan IV over 90 minutes and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV over 46 hours on days 1-2.

* Arm III: Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV over 46 hours on days 1-2.

In all arms, treatment repeats every 2 weeks for 26 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline and then every 3 months for 1 year.

Patients are followed at 2 months.

PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study within 1 year.

Study Timeline

• Study Start: 2002-07-23
• Study First Submitted: 2003-08-06
• Study First Submitted QC: 2003-08-06
• Study First Posted: 2003-08-07
• Primary Completion: 2005-11-04
• Study Completion: 2007-04-01
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-25
• Last Update Posted: 2021-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (17)

Centre Regional Francois Baclesse; 🇫🇷 Caen, France

Centre Eugene Marquis; 🇫🇷 Rennes, France

Centre Antoine Lacassagne; 🇫🇷 Nice, France

CHR D'Orleans - Hopital de la Source; 🇫🇷 Orleans, France

Pole Sante Sarthe et Loir Hopital Pierre Daguet; 🇫🇷 Angers, France

Centre Hospitalier de Rodez; 🇫🇷 Rodez, France

Centre Rene Huguenin; 🇫🇷 Saint Cloud, France

Clinique Sainte-Marguerite; 🇫🇷 Hyeres, France

Centre Hospitalier Departemental; 🇫🇷 La Roche Sur Yon, France

Centre Hospitalier de L' Agglomeration Montargoise; 🇫🇷 Amilly, France

Institut Bergonie; 🇫🇷 Bordeaux, France

Centre Oscar Lambret; 🇫🇷 Lille, France

CHG Roanne; 🇫🇷 Roanne, France

Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle; 🇫🇷 Montpellier, France

Polyclinique Francheville; 🇫🇷 Perigueux, France

Centre Hospitalier General Lucien Hussel; 🇫🇷 Vienne, France

Centre Hospitalier Regional Metz Thionville; 🇫🇷 Thionville, France