Combination of 5-Fluorouracil/Folinate/Oxaliplatin (Eloxatin®) (FLOX regimen) with Concomitant or Concomitant and Maintenance Administration of Cetuximab (Erbitux®), in First-Line Treatment of Metastatic Colorectal Cancer. - Nordic VII

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 550

Inclusion Criteria

Histology and staging disease:
• Histologically proven adenocarcinoma of the colon or rectum;
• At least one measurable metastatic disease ? uni-dimensionnally measurable
lesion according to RECIST criteria;
• If only one metastatic lesion and no S-CEA elevation, histology is mandatory;

General conditions:
• Age >18 and < 75 years;
• WHO performance status < 2; life expectancy of more than 3 months;
• Adequate haematological function: (Hb > 10g/dl, ANC >1.5 x 109/L, platelets >100
x109/L);
• Adequate renal and hepatic functions: total bilirubin <1.5 upper normal limits (unl),
creatinine <1.25 × unl, ALAT < 5 x unl in case of liver involvement;
• Written informed consent prior to randomization must be obtained and ocumented
according to the local regulatory requirements.

Prior therapy:
• No prior chemotherapy for advanced/metastatic disease;
• Adjuvant chemotherapy must have ended > 6 months before inclusion;
• No previous oxaliplatin

Prior or current history:
• No current indication for resection with a curativw intent;
• No evidence of CNS metastasis;
• No current infection, unresolved bowel obstruction or subobstruction, uncontrolled
Crohn's disease or ulcerative colitis;
• No current history of chronic diarrhoea;
• No peripheral neurophathy;
• No other serious illness or medical conditions (including contraindication to 5 FU
eg: angor, myocardial infarction within 6 months, contraindications to monoclonal
antibodies);
• No past or concurrent history of malignant neoplasm other than colorectal
adenocarcinoma within the past five years, except curatively treated non
melanoma skin cancer or in situ carcinoma of the cervix;

Concomitant treatments:
• No concomitant (or within 4 weeks before randomization) administration of any
other experimental drug under investigation;
• No concurrent treatment with any other anti-cancer therapy;

Other:
• Not pregnant or breast feeding
• Fertile patients must use adequate contraceptives
• Not include patients clearly intending to withdraw from the study if not randomised
in the willing arm or patients who cannot be
regularly followed up for psychological, social, familial or geographic reasons.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

See inclusion criteria

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare time to progression, (TTP), of treatment with cetuximab in combination with the FLOX regimen given continuously (arm B) or intermittently (arm C), with TTP of the FLOX regimen alone (arm A), in first line treatment of patient with metastatic colorectal cancer. TTP is calculated from date of randomization to first progression of disease.<br>;Secondary Objective: • Response rates in the three treatment arms.<br>• Response duration in the three treatment arms.<br>• Secondary surgical curative resection frequency.<br>• Safety profile of the treatment arms.<br>• Overall survival in the treatment groups.<br>• Quality of life in the treatment groups.<br>;Primary end point(s): Time to progression

Secondary Outcome Measures

Name	Time	Method

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