Irinotecan With or Without Capecitabine as Second-Line Therapy in Treating Older Patients With Progressive, Metastatic Colorectal Cancer That Cannot Be Removed By Surgery

Phase 2

• Conditions: Colorectal Cancer

• Registration Number: NCT00303745
• Lead Sponsor: Federation Francophone de Cancerologie Digestive

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as irinotecan and capecitabine, 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) may kill more tumor cells. It is not yet known whether irinotecan and capecitabine are more effective than irinotecan alone in treating colorectal cancer.

PURPOSE: This randomized phase II trial is studying irinotecan and capecitabine to see how well they work as second-line therapy compared to irinotecan alone in treating older patients with progressive, metastatic colorectal cancer that cannot be removed by surgery.

Detailed Description

OBJECTIVES:

Primary

* Compare the objective response or stable disease rate in elderly patients with unresectable, progressive, metastatic colorectal cancer treated with irinotecan hydrochloride with vs without capecitabine.

Secondary

* Compare the tolerability of these regimens in these patients.

* Compare the quality of life and ability to maintain self-sufficiency of patients treated with these regimens.

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

OUTLINE: This is an open-label, randomized, multicenter study. Patients are stratified according to participating center, WHO performance status (0 or 1 vs 2), number of associated comorbidities (Charlson index 0-2 vs \> 2), and age (75-79 vs ≥ 80). Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive irinotecan hydrochloride IV over 90 minutes on day 1. Treatment repeats every 2 weeks for 2 courses in the absence of disease progression or unacceptable toxicity.

* Arm II: Patients receive oral capecitabine on days 1-14 and irinotecan hydrochloride IV over 90 minutes on day 1. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline and then every 12 weeks thereafter.

After completion of study therapy, patients are followed every 12 weeks.

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

Study Timeline

• Study First Submitted: 2006-03-15
• Study First Submitted QC: 2006-03-15
• Study First Posted: 2006-03-17
• Study Start: 2006-06
• Status Verified: 2006-12
• Last Update Submitted: 2008-07-23
• Last Update Posted: 2008-07-24

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 78

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Objective response
Stable disease rate

Secondary Outcome Measures

Name	Time	Method
Tolerability
Quality of life
Progression-free and overall survival

Trial Locations

Locations (23)

Centre Hospitalier d'Abbeville; 🇫🇷 Abbeville, France

Polyclinique Bordeaux Nord Aquitaine; 🇫🇷 Boucher, France

Centre Hospitalier Universitaire Ambroise Pare - Boulogne; 🇫🇷 Boulogne, France

Centre Hospitalier; 🇫🇷 Chalon Sur Saone, France

Hopital Antoine Beclere; 🇫🇷 Clamart, France

Hopital Du Bocage; 🇫🇷 Dijon, France

Clinique Pasteur; 🇫🇷 Guilherand Granges, France

CMC Les Ormeaux; 🇫🇷 Le Havre, France

C. H. Du Mans; 🇫🇷 Le Mans, France

Hopital Robert Boulin; 🇫🇷 Libourne, France

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