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

December 20, 2005
May 21, 2012
July 2002
December 2011   (final data collection date for primary outcome measure)
disease-free survival [ Time Frame: 2-year ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00268398 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
Not Provided
 
Combination Chemotherapy in Treating Patients With Colorectal Cancer and Resectable Metastases
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Colorectal Cancer
  • Metastatic Cancer
  • Chemotherapy
  • 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)
  • 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)

  • Active Comparator: FOLFOX4
    Intervention: Drug: oxaliplatin, folinic acid, fluorouracil
  • Experimental: FOLFOX7 followed by FOLFIRI
    Intervention: Drug: oxaliplatin, irinotecan, folinic acid, fluorouracil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
284
Not Provided
December 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00268398
CDR0000453815, GERCOR-C02-1, GERCOR-C02-1-MIROX, EU-20567, SANOFI-GERCOR-C02-1
Not Provided
Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
Not Provided
Study Chair: Mohamed Hebbar, MD Centre Hospital Universitaire Hop Huriez
Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP