Status:
COMPLETED
FLOX in Combination With Cetuximab in First-line Treatment of Colorectal Cancer
Lead Sponsor:
The Nordic Colorectal Cancer Biomodulation Group
Conditions:
Metastatic Colorectal Cancer
Eligibility:
All Genders
18-74 years
Phase:
PHASE3
Brief Summary
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 rece...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
571 Patients enrolled
Trial Details
Trial ID
NCT00145314
Start Date
May 1 2005
End Date
August 1 2010
Last Update
January 14 2011
Active Locations (1)
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1
The Nordic Colorectal Cancer Biomodulation Group
Oslo, Norway, NO-0407