Combination Chemotherapy in Treating Patients With Colorectal Cancer and Resectable Metastases

Colorectal Cancer Clinical Trial

— MIROX  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00268398
• Other study ID #: CDR0000453815
• Secondary ID: GERCOR-C02-1GERC
• Status: Completed
• Phase: Phase 3
• First received: December 20, 2005
• Last updated: May 21, 2012
• Start date: July 2002

Study information

• Verified date: May 2012
• Source: Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence française de sécurité sanitaire des produits de santé (AFSSAPS)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 284
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Chemotherapy
• Colorectal Cancer
• Colorectal Neoplasms
• Metastatic Cancer
• Neoplasm Metastasis

Intervention

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)
• 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)

Locations

Country	Name	City	State
France	Hopital Duffaut	Avignon
France	Institut Sainte Catherine	Avignon
France	C.H.G. Beauvais	Beauvais
France	Hopital Saint Andre	Bordeaux
France	Centre Hospitalier Docteur Duchenne	Boulogne Sur Mer
France	Hopital Ambroise Pare	Boulogne-Billancourt
France	Centre Hospitalier de Briey	Briey
France	Centre Regional Francois Baclesse	Caen
France	Hopital Louis Pasteur	Chartres
France	Hopital Beaujon	Clichy
France	Louis Mourier Hospital	Colombes Cedex
France	Clinique du Parc	Croix
France	Hopital Drevon	Dijon
France	Centre Hospitalier Departemental	La Roche Sur Yon
France	Hopital Saint - Louis	La Rochelle
France	Hopital Robert Boulin	Libourne
France	Centre Hospital Universitaire Hop Huriez	Lille
France	Polyclinique Du Bois	Lille
France	Polyclinique des Quatre Pavillons	Lormont
France	Hopital Saint Joseph	Marseille
France	Hopital Notre-Dame de Bon Secours	Metz
France	Centre Hospitalier Intercommunal Le Raincy - Montfermeil	Montfermeil
France	CHU Pitie-Salpetriere	Paris
France	Hopital Europeen Georges Pompidou	Paris
France	Hopital Saint Antoine	Paris
France	Hopital Tenon	Paris
France	Hopital Haut Leveque	Pessac
France	Polyclinique De Courlancy	Reims
France	Clinique Specialise du Littoral-Cote d'Opale	Saint Martin Boulogne
France	Clinique Charcot	Sainte Foy Les Lyon
France	C.H. Senlis	Senlis
France	Hopital Foch	Suresnes

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	disease-free survival		2-year	No
Secondary	Overall survival		2-year, 3-year, 5-year	No
Secondary	Tolerability		2-year	Yes
Secondary	Quality of life		2-year	No
Secondary	Pharmacogenetics		2-year	No