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

History of Changes

Tracking Information

First Received Date ^ICMJE

December 20, 2005

Last Updated Date

May 21, 2012

Start Date ^ICMJE

July 2002

Primary Completion Date

December 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00268398 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Combination Chemotherapy in Treating Patients With Colorectal Cancer and Resectable Metastases

Official Title ^ICMJE

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

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.

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 ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Colorectal Cancer
Metastatic Cancer
Chemotherapy

Intervention ^ICMJE

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)

Study Arm (s)

Active Comparator: FOLFOX4
Intervention: Drug: oxaliplatin, folinic acid, fluorouracil
Experimental: FOLFOX7 followed by FOLFIRI
Intervention: Drug: oxaliplatin, irinotecan, folinic acid, fluorouracil

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

284

Completion Date

Not Provided

Primary Completion Date

December 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT00268398

Other Study ID Numbers ^ICMJE

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

Has Data Monitoring Committee

Not Provided

Responsible Party

Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)

Study Sponsor ^ICMJE

Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Mohamed Hebbar, MD

Centre Hospital Universitaire Hop Huriez

Information Provided By

Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)

Verification Date

May 2012

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

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