5-Fluorouracil/Folinate/Oxaliplatin (Eloxatin) (FLOX Regimen), Given Continuously or Intermittently, in Combination With Cetuximab (Erbitux), in First-line Treatment of Metastatic Colorectal Cancer. A Phase III Multicenter Trial.
Overview
- Phase
- Phase 3
- Intervention
- FLOX (5-fluorouracil/folinic acid/oxaliplatin)
- Conditions
- Metastatic Colorectal Cancer
- Sponsor
- The Nordic Colorectal Cancer Biomodulation Group
- Enrollment
- 571
- Locations
- 1
- Primary Endpoint
- 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
- Status
- Completed
- Last Updated
- 15 years ago
Overview
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.
Investigators
Eligibility 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
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;
Arms & Interventions
A
FLOX: 5-fluorouracil/folinic acid/oxaliplatin; Nordic Regimen; given continuosly
Intervention: FLOX (5-fluorouracil/folinic acid/oxaliplatin)
B
FLOX: 5-fluorouracil/folinic acid/oxaliplatin and cetuximab
Intervention: FLOX (5-fluorouracil/folinic acid/oxaliplatin) and Cetuximab
C
FLOX given intermittently and maintenance cetuximab
Intervention: FLOX (5-fluorouracil and folinic acid and oxaliplatin) intermittently and maintenance cetuximab
Outcomes
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
Time Frame: Every 4th cycle
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.(Every 2nd week (safety profile))