Combination Chemotherapy as First-Line Therapy in Treating Older Patients With Metastatic Colorectal Cancer That Cannot Be Removed By Surgery

Phase 3

Completed

• Conditions: Colorectal Cancer
• Interventions: Drug: fluorouracil; Drug: leucovorin calcium; Drug: irinotecan hydrochloride

• Registration Number: NCT00303771
• Lead Sponsor: Federation Francophone de Cancerologie Digestive

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as fluorouracil, leucovorin, and irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) in different doses or combinations may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective in treating colorectal cancer.

PURPOSE: This randomized clinical trial is studying how well fluorouracil works together with leucovorin with or without irinotecan in treating older patients with metastatic colorectal cancer .

Detailed Description

OBJECTIVES:

Primary

* Compare the progression-free survival of elderly patients with unresectable metastatic colorectal cancer treated with 1 of 2 different chemotherapy regimens comprising fluorouracil and leucovorin calcium with vs without irinotecan hydrochloride.

Secondary

* Compare the tumor response rate and overall 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, prospective study. Patients are stratified according to participating center, gender, Karnofsky score (60-70% vs 80-90% vs 100%), associated comorbidities (Charlson Index 0 vs 1-2 vs 3+), age (75 to 79 years vs ≥ 80 years), alkaline phosphatase level (≤ 2 times normal vs \> 2 times normal), and prior adjuvant chemotherapy (yes vs no). Patients are randomized to 1 of 4 treatment arms.

* Arm I: Patients receive leucovorin calcium IV over 2 hours and fluorouracil IV continuously over 22 hours on days 1 and 2.

* Arm II: Patients receive leucovorin calcium IV over 2 hours and fluorouracil IV continuously over 46 hours on days 1 and 2.

* Arm III: Patients receive leucovorin calcium and fluorouracil as in arm I and irinotecan hydrochloride IV over 90 minutes on day 1.

* Arm IV: Patients receive leucovorin calcium and fluorouracil as in arm II and irinotecan hydrochloride as in arm III.

In all arms, treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.

Patients undergo surgery within 3-10 weeks after completing chemotherapy.

Quality of life is assessed at baseline and then every 2 months thereafter.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 282 patients will be accrued for this study.

Study Timeline

• Study Start: 2003-06
• Study First Submitted: 2006-03-15
• Study First Submitted QC: 2006-03-15
• Study First Posted: 2006-03-17
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-27
• Last Update Posted: 2016-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 282

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LV5FU2 simplifié	fluorouracil	LV5FU2 simplifié
LV5FU2 classique	fluorouracil	LV5FU2 classique
LV5FU2 classique	leucovorin calcium	LV5FU2 classique
LV5FU2 simplifié	leucovorin calcium	LV5FU2 simplifié
LV5FU2 classique + irinotécan	leucovorin calcium	LV5FU2 classique + irinotécan
LV5FU2 simplifié+ irinotécan	fluorouracil	LV5FU2 simplifié + irinotécan
LV5FU2 simplifié+ irinotécan	irinotecan hydrochloride	LV5FU2 simplifié + irinotécan
LV5FU2 simplifié+ irinotécan	leucovorin calcium	LV5FU2 simplifié + irinotécan
LV5FU2 classique + irinotécan	irinotecan hydrochloride	LV5FU2 classique + irinotécan
LV5FU2 classique + irinotécan	fluorouracil	LV5FU2 classique + irinotécan

Primary Outcome Measures

Name	Time	Method
Progression Free Survival (survie sans progression)	2011	survie sans progression

Secondary Outcome Measures

Name	Time	Method
Overall Survival (survie globale)	2011	survie globale

Trial Locations

Locations (77)

Centre Hospitalier d'Abbeville; 🇫🇷 Abbeville, France

Centre Hospitalier D'Agen; 🇫🇷 Agen, France

Centre hospitalier d'Alencon; 🇫🇷 Alencon, France

Clinique De Rochebelle; 🇫🇷 Ales, France

Centre Hospitalier Universitaire d'Amiens; 🇫🇷 Amiens, France

Centre Hospitalier d'Annecy; 🇫🇷 Annecy, France

Institut Sainte Catherine; 🇫🇷 Avignon, France

Hopital Duffaut; 🇫🇷 Avignon, France

Centre Hospitalier de Blois; 🇫🇷 Blois, France

Hopital Saint Andre; 🇫🇷 Bordeaux, France

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