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

The Nordic Colorectal Cancer Biomodulation Group

Status and phase: Completed; Phase 3

Conditions: Metastatic Colorectal Cancer

Treatments: Drug: FLOX (5-fluorouracil/folinic acid/oxaliplatin); Drug: FLOX (5-fluorouracil and folinic acid and oxaliplatin) intermittently and maintenance cetuximab; Drug: FLOX (5-fluorouracil/folinic acid/oxaliplatin) and Cetuximab

Study type: Interventional

Funder types: Other

Identifiers

NCT00145314

EudraCT no.: 2005-000117-34

Nordic VII

Details and patient eligibility

About

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.

Enrollment: 571 patients

Sex: All

Ages: 18 to 74 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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571 participants in 3 patient groups

A

Active Comparator group

Description:

FLOX: 5-fluorouracil/folinic acid/oxaliplatin; Nordic Regimen; given continuosly

Treatment:

Drug: FLOX (5-fluorouracil/folinic acid/oxaliplatin)

B

Experimental group

Description:

FLOX: 5-fluorouracil/folinic acid/oxaliplatin and cetuximab

Treatment:

Drug: FLOX (5-fluorouracil/folinic acid/oxaliplatin) and Cetuximab

C

Experimental group

Description:

FLOX given intermittently and maintenance cetuximab

Treatment:

Drug: FLOX (5-fluorouracil and folinic acid and oxaliplatin) intermittently and maintenance cetuximab