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

Sponsor
GERCOR - Multidisciplinary Oncology Cooperative Group (Other)
Overall Status
Completed
CT.gov ID
NCT00268398
Collaborator
(none)
284
Enrollment
32
Locations
2
Arms
8.9
Patients Per Site

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Drug: oxaliplatin, folinic acid, fluorouracil
  • Drug: oxaliplatin, irinotecan, folinic acid, fluorouracil
 Phase 3

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 Design

Study Type:
Interventional
Actual Enrollment :
284 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (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
Study Start Date :
Jul 1, 2002
Actual Primary Completion Date :
Dec 1, 2011

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

  1. disease-free survival [2-year]

Secondary Outcome Measures

  1. Overall survival [2-year, 3-year, 5-year]

  2. Tolerability [2-year]

  3. Quality of life [2-year]

  4. Pharmacogenetics [2-year]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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

Locations

Site City State Country Postal Code
1 Institut Sainte Catherine Avignon France 84000
2 Hopital Duffaut Avignon France 84902
3 C.H.G. Beauvais Beauvais France 60021
4 Hopital Saint Andre Bordeaux France 33075
5 Centre Hospitalier Docteur Duchenne Boulogne Sur Mer France 62200
6 Hopital Ambroise Pare Boulogne-Billancourt France F-92104
7 Centre Hospitalier de Briey Briey France 54151
8 Centre Regional Francois Baclesse Caen France 14076
9 Hopital Louis Pasteur Chartres France 28018
10 Hopital Beaujon Clichy France 92118
11 Louis Mourier Hospital Colombes Cedex France 92701
12 Clinique du Parc Croix France 59170
13 Hopital Drevon Dijon France 21000
14 Centre Hospitalier Departemental La Roche Sur Yon France F-85025
15 Hopital Saint - Louis La Rochelle France 17000
16 Hopital Robert Boulin Libourne France 33500
17 Polyclinique Du Bois Lille France 59000
18 Centre Hospital Universitaire Hop Huriez Lille France 59037
19 Polyclinique des Quatre Pavillons Lormont France 33310
20 Hopital Saint Joseph Marseille France 13008
21 Hopital Notre-Dame de Bon Secours Metz France 57038
22 Centre Hospitalier Intercommunal Le Raincy - Montfermeil Montfermeil France 93370
23 Hopital Europeen Georges Pompidou Paris France 75015
24 Hopital Saint Antoine Paris France 75571
25 CHU Pitie-Salpetriere Paris France 75651
26 Hopital Tenon Paris France 75970
27 Hopital Haut Leveque Pessac France 33604
28 Polyclinique De Courlancy Reims France F-51100
29 Clinique Specialise du Littoral-Cote d'Opale Saint Martin Boulogne France 62280
30 Clinique Charcot Sainte Foy Les Lyon France 69110
31 C.H. Senlis Senlis France 60309
32 Hopital Foch Suresnes France 92151

Sponsors and Collaborators

  • GERCOR - Multidisciplinary Oncology Cooperative Group

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
GERCOR - Multidisciplinary Oncology Cooperative Group
ClinicalTrials.gov Identifier:
NCT00268398
Other Study ID Numbers:
  • CDR0000453815
  • GERCOR-C02-1
  • GERCOR-C02-1-MIROX
  • EU-20567
  • SANOFI-GERCOR-C02-1
First Posted:
Dec 22, 2005
Last Update Posted:
May 22, 2012
Last Verified:
May 1, 2012
Keywords provided by GERCOR - Multidisciplinary Oncology Cooperative Group
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
Leucovorin
Folic Acid
Fluorouracil
Oxaliplatin
Irinotecan
Levoleucovorin

Study Results

No Results Posted as of May 22, 2012