Metastatic Colorectal Cancer
Conditions
Keywords
Metastatic colorectal cancer, FLOX, Cetuximab
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 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.
Interventions
DRUGFLOX (5-fluorouracil/folinic acid/oxaliplatin)
FLOX every 2nd week
DRUGFLOX (5-fluorouracil/folinic acid/oxaliplatin) and Cetuximab
FLOX every 2nd week Cetuximab weekly
DRUGFLOX (5-fluorouracil and folinic acid and oxaliplatin) intermittently and maintenance cetuximab
FLOX every 2nd week for 8 cycles. Stop of FLOX until progression then FLOX is reintroduced. Cetuximab weekly.
Sponsors
The Nordic Colorectal Cancer Biomodulation Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 74 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | Every 4th cycle |
Secondary
| Measure | Time frame |
|---|---|
| To measure response rates, response duration, secondary surgical curative resection frequency, safety profile, overall survival and quality of life in the treatment groups. | Every 2nd week (safety profile) |
Countries
Norway
Outcome results
None listed