FLOX in Combination With Cetuximab in First-line Treatment of Colorectal Cancer

Metastatic Colorectal Cancer Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00145314
• Other study ID #: Nordic VII
• Secondary ID: EudraCT no.: 200
• Status: Completed
• Phase: Phase 3
• First received: September 2, 2005
• Last updated: January 13, 2011
• Start date: May 2005
• Est. completion date: August 2010

Study information

• Verified date: January 2011
• Source: The Nordic Colorectal Cancer Biomodulation Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Medicines AgencySweden: Medical Products AgencyDenmark: National Board of HealthFinland: Finnish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 571
• Est. completion date: August 2010
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 74 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer

Intervention

Drug:
• FLOX (5-fluorouracil/folinic acid/oxaliplatin)
FLOX every 2nd week
• FLOX (5-fluorouracil/folinic acid/oxaliplatin) and Cetuximab
FLOX every 2nd week Cetuximab weekly
• FLOX (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.

Locations

Country	Name	City	State
Norway	The Nordic Colorectal Cancer Biomodulation Group	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
The Nordic Colorectal Cancer Biomodulation Group

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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)	Yes