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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
ClinicalTrials.gov Identifier:
NCT00268398
First received: December 20, 2005
Last updated: May 21, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
Colorectal Cancer
Metastatic Cancer
Chemotherapy
Drug: oxaliplatin, folinic acid, fluorouracil
Drug: oxaliplatin, irinotecan, folinic acid, fluorouracil
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR):

Primary Outcome Measures:
  • disease-free survival [ Time Frame: 2-year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: 2-year, 3-year, 5-year ] [ Designated as safety issue: No ]
  • Tolerability [ Time Frame: 2-year ] [ Designated as safety issue: Yes ]
  • Quality of life [ Time Frame: 2-year ] [ Designated as safety issue: No ]
  • Pharmacogenetics [ Time Frame: 2-year ] [ Designated as safety issue: No ]

Enrollment: 284
Study Start Date: July 2002
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)


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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00268398

Locations
France
Hopital Duffaut
Avignon, France, 84902
Institut Sainte Catherine
Avignon, France, 84000
C.H.G. Beauvais
Beauvais, France, 60021
Hopital Saint Andre
Bordeaux, France, 33075
Centre Hospitalier Docteur Duchenne
Boulogne Sur Mer, France, 62200
Hopital Ambroise Pare
Boulogne-Billancourt, France, F-92104
Centre Hospitalier de Briey
Briey, France, 54151
Centre Regional Francois Baclesse
Caen, France, 14076
Hopital Louis Pasteur
Chartres, France, 28018
Hopital Beaujon
Clichy, France, 92118
Louis Mourier Hospital
Colombes Cedex, France, 92701
Clinique du Parc
Croix, France, 59170
Hopital Drevon
Dijon, France, 21000
Centre Hospitalier Departemental
La Roche Sur Yon, France, F-85025
Hopital Saint - Louis
La Rochelle, France, 17000
Hopital Robert Boulin
Libourne, France, 33500
Polyclinique Du Bois
Lille, France, 59000
Centre Hospital Universitaire Hop Huriez
Lille, France, 59037
Polyclinique des Quatre Pavillons
Lormont, France, 33310
Hopital Saint Joseph
Marseille, France, 13008
Hopital Notre-Dame de Bon Secours
Metz, France, 57038
Centre Hospitalier Intercommunal Le Raincy - Montfermeil
Montfermeil, France, 93370
CHU Pitie-Salpetriere
Paris, France, 75651
Hopital Europeen Georges Pompidou
Paris, France, 75015
Hopital Saint Antoine
Paris, France, 75571
Hopital Tenon
Paris, France, 75970
Hopital Haut Leveque
Pessac, France, 33604
Polyclinique De Courlancy
Reims, France, F-51100
Clinique Specialise du Littoral-Cote d'Opale
Saint Martin Boulogne, France, 62280
Clinique Charcot
Sainte Foy Les Lyon, France, 69110
C.H. Senlis
Senlis, France, 60309
Hopital Foch
Suresnes, France, 92151
Sponsors and Collaborators
Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
Investigators
Study Chair: Mohamed Hebbar, MD Centre Hospital Universitaire Hop Huriez
  More Information

Additional Information:
No publications provided

Responsible Party: Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
ClinicalTrials.gov Identifier: NCT00268398     History of Changes
Other Study ID Numbers: CDR0000453815, GERCOR-C02-1, GERCOR-C02-1-MIROX, EU-20567, SANOFI-GERCOR-C02-1
Study First Received: December 20, 2005
Last Updated: May 21, 2012
Health Authority: France: Agence française de sécurité sanitaire des produits de santé (AFSSAPS)

Keywords provided by Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR):
adenocarcinoma of the colon
stage IV colon cancer
adenocarcinoma of the rectum
stage IV rectal cancer
resectable metastases

Additional relevant MeSH terms:
Colorectal Neoplasms
Neoplasm Metastasis
Neoplasms
Neoplasms, Second Primary
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes
Fluorouracil
Oxaliplatin
Irinotecan
Leucovorin
Folic Acid
Levoleucovorin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 22, 2014