Combination Chemotherapy in Treating Patients With Colorectal Cancer and Resectable Metastases (MIROX)

May 21, 2012 updated by: GERCOR - Multidisciplinary Oncology Cooperative Group

Essai De Phase III De Chimiotherapie Par FOLFOX 4 Ou Par Une Succession FOLFOX 7 - FOLFIRI Chez Des Patients Ayant Des Metastases Resecables D'Origine Colorectale - MIROX

PURPOSE: This randomized phase III trial is studying two different combination chemotherapy regimens to compare how well they work in treating patients with colorectal cancer and resectable metastases.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

Primary

  • Compare the 2-year disease-free survival rate in patients treated with these regimens.

Secondary

  • Compare the 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.
  • Compare the objective response rate, postoperative complication rate, and transfusing rate in patients having metastasis surgery,
  • Determine the pharmacogenetics of these regimens in these patients.

OUTLINE: This is a randomized, open-label, multicenter phase III study. Patients are stratified according to prior chemotherapy (perioperative vs postoperative), prior treatment (surgery only vs radiotherapy with or without surgery), and Blumgart score (0-1 vs 2-3 vs 4-5). Patients are randomized to 1 of 2 treatment arms.

  • Arm I (FOLFOX 4): Patients receive FOLFOX 4 combination chemotherapy comprising oxaliplatin 85mg/m² IV over 2 hours, leucovorin calcium IV over 2 hours, fluorouracil IV bolus /15min and fluorouracil continuously over 22 hours on day 1. Treatment repeats every 2 weeks for 12 courses in the absence of disease progression or unacceptable toxicity.
  • Arm II (FOLFOX 7 and FOLFIRI): Patients receive FOLFOX 7 combination chemotherapy comprising high-dose oxaliplatin 130mg/m² IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV over 46 hours on days 1 and 2. Treatment repeats every 2 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive FOLFIRI combination chemotherapy comprising irinotecan hydrochloride 180mg/m² IV over 30-90 minutes and leucovorin calcium and fluorouracil IV bolus /15min on day 1, and fluorouracil IV continuously over 46 hours on days 1 and 2. Treatment repeats every 2 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.

Patients in both arms who have undergone prior resection of metastatic lesions may undergo surgery after 6 courses of chemotherapy or after chemotherapy is completed.

Quality of life is assessed at baseline and after courses 4, 8, and 12.

After completion of study treatment, patients are followed periodically for 5 years.

PROJECTED ACCRUAL: A total of 284 patients will be accrued for this study.

Study Type

Interventional

Enrollment (Actual)

284

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Avignon, France, 84000
        • Institut Sainte Catherine
      • Avignon, France, 84902
        • Hopital Duffaut
      • Beauvais, France, 60021
        • C.H.G. Beauvais
      • Bordeaux, France, 33075
        • Hopital Saint André
      • Boulogne Sur Mer, France, 62200
        • Centre Hospitalier Docteur Duchenne
      • Boulogne-Billancourt, France, F-92104
        • Hôpital Ambroise Paré
      • Briey, France, 54151
        • Centre Hospitalier de Briey
      • Caen, France, 14076
        • Centre Regional Francois Baclesse
      • Chartres, France, 28018
        • Hôpital Louis Pasteur
      • Clichy, France, 92118
        • Hopital Beaujon
      • Colombes Cedex, France, 92701
        • Louis Mourier Hospital
      • Croix, France, 59170
        • Clinique du Parc
      • Dijon, France, 21000
        • Hopital Drevon
      • La Roche Sur Yon, France, F-85025
        • Centre Hospitalier departemental
      • La Rochelle, France, 17000
        • Hopital Saint - Louis
      • Libourne, France, 33500
        • Hôpital Robert Boulin
      • Lille, France, 59037
        • Centre Hospital Universitaire Hop Huriez
      • Lille, France, 59000
        • Polyclinique du Bois
      • Lormont, France, 33310
        • Polyclinique des Quatre Pavillons
      • Marseille, France, 13008
        • Hopital Saint Joseph
      • Metz, France, 57038
        • Hopital Notre-Dame de Bon Secours
      • Montfermeil, France, 93370
        • Centre Hospitalier Intercommunal Le Raincy - Montfermeil
      • Paris, France, 75015
        • Hôpital Europeén Georges Pompidou
      • Paris, France, 75651
        • CHU Pitié-Salpétrière
      • Paris, France, 75970
        • Hôpital Tenon
      • Paris, France, 75571
        • Hopital Saint Antoine
      • Pessac, France, 33604
        • Hopital Haut Lévêque
      • Reims, France, F-51100
        • Polyclinique de Courlancy
      • Saint Martin Boulogne, France, 62280
        • Clinique Specialise du Littoral-Cote d'Opale
      • Sainte Foy Les Lyon, France, 69110
        • Clinique Charcot
      • Senlis, France, 60309
        • C.H. Senlis
      • Suresnes, France, 92151
        • Hôpital Foch

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

MAIN ELIGIBILITY CRITERIA

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the colon or rectum
  • Resectable or resected metastatic disease,

PATIENT CHARACTERISTICS:

  • WHO performance status 0-2
  • Alkaline phosphatase ≤ 5 times upper limit of normal (ULN)
  • Bilirubin ≤ 2 times normal
  • Creatinine ≤ 135 mmol/L or creatinine clearance ≥ 60 mL/min
  • SGOT and SGPT ≤ 3 times ULN
  • No peripheral neuropathy that affects normal functions
  • No unresolved complications from prior surgery

PRIOR CONCURRENT THERAPY:

  • At least 1 year since prior FOLFOX 4 or FOLFIRI regimen in the adjuvant setting
  • No concurrent participation in another clinical trial
  • Recovered from prior therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: FOLFOX4
Drug: oxaliplatin, folinic acid, fluorouracil
folinic acid 200 mg/m² (day 1&2) oxaliplatin 85 mg/m² (day 1) bolus 5FU 400 mg/m² (day 1&2) continuous 5FU 600mg/m² (day 1 to 2)
Experimental: FOLFOX7 followed by FOLFIRI
Drug: oxaliplatin, irinotecan, folinic acid, fluorouracil

FOLFOX7 folinic acid 400 mg/m² (day 1) oxaliplatin 130 mg/m² (day 1) continuous 5FU 3000mg/m² (day 1 to 2)

FOLFIRI folinic acid 400 mg/m² (day 1) irinotecan 180 mg/m² (day 1) bolus 5FU 400 mg/m² (day 1) continuous 5FU 2400mg/m² (day 1 to 2)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
disease-free survival
Time Frame: 2-year
2-year

Secondary Outcome Measures

Outcome Measure
Time Frame
Tolerability
Time Frame: 2-year
2-year
Overall survival
Time Frame: 2-year, 3-year, 5-year
2-year, 3-year, 5-year
Quality of life
Time Frame: 2-year
2-year
Pharmacogenetics
Time Frame: 2-year
2-year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GERCOR - Multidisciplinary Oncology Cooperative Group

Investigators

  • Study Chair: Mohamed Hebbar, MD, Centre Hospital Universitaire Hop Huriez

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2002

Primary Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

December 20, 2005

First Submitted That Met QC Criteria

December 20, 2005

First Posted (Estimate)

December 22, 2005

Study Record Updates

Last Update Posted (Estimate)

May 22, 2012

Last Update Submitted That Met QC Criteria

May 21, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000453815
  • GERCOR-C02-1
  • GERCOR-C02-1-MIROX
  • EU-20567
  • SANOFI-GERCOR-C02-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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