Fluorouracil, Leucovorin, and Irinotecan in Treating Patients With Recurrent or Refractory Metastatic Unresectable Colorectal Cancer

Phase 2

• Conditions: Colorectal Cancer

• Registration Number: NCT00075595
• Lead Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as fluorouracil, leucovorin, and irinotecan, use different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one chemotherapy drug may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving fluorouracil together with leucovorin and irinotecan works in treating patients with recurrent or refractory metastatic unresectable colorectal cancer.

Detailed Description

OBJECTIVES:

Primary

* Determine the time to progression and time to death from progression in patients with recurrent or refractory metastatic unresectable colorectal cancer treated with fluorouracil, leucovorin calcium, and irinotecan.

Secondary

* Determine the objective response and stabilization rate in patients treated with this regimen.

* Determine the time to treatment failure in patients treated with this regimen.

* Determine the duration of response in patients treated with this regimen.

* Determine overall survival rate in patients treated with this regimen.

* Determine the incidence of grade 3 or 4 toxicity in patients treated with this regimen.

OUTLINE: This is an open-label, multicenter study.

Patients receive leucovorin calcium IV over 2 hours on day 1, irinotecan IV over 1 hour on days 1 and 3, and fluorouracil IV continuously over 46 hours beginning on day 1. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 78 patients will be accrued for this study within 18 months.

Study Timeline

• Study Start: 2002-06
• Study First Submitted: 2004-01-09
• Study First Submitted QC: 2004-01-11
• Study First Posted: 2004-01-12
• Status Verified: 2007-08
• Last Update Submitted: 2009-01-03
• Last Update Posted: 2009-01-06

Recruitment & Eligibility

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

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to progression
Time to death from progression

Secondary Outcome Measures

Name	Time	Method
Objective response
Stabilization rate
Time to treatment failure
Duration of response
Overall survival rate
Incidence of grade 3 or 4 toxicity

Trial Locations

Locations (15)

Polyclinique De Courlancy; 🇫🇷 Reims, France

Clinique Armoricaine De Radiologie; 🇫🇷 Saint Brieuc, France

Clinique Saint Jean; 🇫🇷 Lyon, France

Hopital Saint Joseph; 🇫🇷 Marseille, France

American Hospital of Paris; 🇫🇷 Neuilly Sur Seine, France

Clinique Ste - Marie; 🇫🇷 Pontoise, France

Hopital Drevon; 🇫🇷 Dijon, France

Centre Hospital Universitaire Hop Huriez; 🇫🇷 Lille, France

Clinique de l'Orangerie; 🇫🇷 Strasbourg, France

Centre Medico-Chirurgical Foch; 🇫🇷 Suresnes, France

Hopital Bichat - Claude Bernard; 🇫🇷 Paris, France

Hopital Saint Antoine; 🇫🇷 Paris, France

Hopital Tenon; 🇫🇷 Paris, France

Intercommunal Hospital; 🇫🇷 Montfermeil, France

Hopital Europeen Georges Pompidou; 🇫🇷 Paris, France