The main objective of this trial is to explore the effect of combining an established chemotherapy regimen (FLOX), based on 5-fluorouracil, folinic acid, and oxaliplatin (Eloxatin®), with the EGF receptor antibody cetuximab (Erbitux®) in first-line treatment of metastatic colorectal cancer. The trial will investigate two regimens of FLOX plus cetuximab, in which FLOX is given continuously or intermittently, compared to standard FLOX without cetuximab.

Condition	Intervention	Phase
Metastatic Colorectal Cancer	Drug: FLOX (5-fluorouracil/folinic acid/oxaliplatin)  Drug: FLOX (5-fluorouracil/folinic acid/oxaliplatin) and Cetuximab	Phase III

Further Study Details: 

Primary Outcomes: To compare efficacy, as measured by time to disease progression, of treatment with cetuximab in combination with the FLOX regimen compared to FLOX alone, in first- line treatment of patients with metastatic cororectal cancer
Secondary Outcomes: To measure response rates, response duration, secondary surgical curative resection frequency, safety profile, overall survival and quality of life in the treatment groups.
Expected Total Enrollment:  550

Ages Eligible for Study:  18 Years   -   74 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

Histology and staging disease:

• Histological proven adenocarcinoma of the colon or rectum;
• At least one measurable metastatic disease
• If only one metastatic lesion and no S-CEA elevation, histology is mandatory;
• Availability of tumour sample for EGFR assessment.

General conditions:

• Age >18 and < 75 years;
• WHO performance status: life expectancy of more than 3 months;
• Adequate haematological function
• Adequate renal and hepatic functions
• Written informed consent

Exclusion Criteria:

Prior therapy:

• No prior chemotherapy for advanced/metastatic disease;
• No adjuvant chemotherapy the last 6 months before inclusion;
• No previous oxaliplatin;

Prior or current history:

• No current indication for resection with a curative 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 neuropathy;
• No other serious illness or medical conditions (including contraindication to 5 FU e.g.: 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 randomisation) administration of any other experimental drug under investigation;
• No concurrent treatment with any other anti-cancer therapy;

Other:

• Not pregnant, no 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, familiar or geographic reasons.

Please refer to this study by ClinicalTrials.gov identifier  NCT00145314

Kjell M. Tveit, MD, PhD      +47 22 11 93 16    kjell.tveit@uus.no

Norway
      The Nordic Colorectal Cancer Biomodulation Group, Oslo,  NO-0407,  Norway; Recruiting

Study chairs or principal investigators

Kjell M. Tveit, MD, PhD,  Principal Investigator,  Professor at Ullevål University Hospital, Norway   

Study ID Numbers:  Nordic VII; EudraCT no.: 2005-000117-34
Last Updated:  September 2, 2005
Record first received:  September 2, 2005
ClinicalTrials.gov Identifier:  NCT00145314
Health Authority: Norway: Norwegian Medicines Agency; Sweden: Medical Products Agency; Denmark: National Board of Health; Finland: National Agency for Medicines
ClinicalTrials.gov processed this record on 2005-09-06