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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

571 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-05-31

Study Completion Date

2010-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Metastatic Colorectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

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

Group Type ACTIVE_COMPARATOR

FLOX (5-fluorouracil/folinic acid/oxaliplatin)

Intervention Type DRUG

FLOX every 2nd week

B

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

Group Type EXPERIMENTAL

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

Intervention Type DRUG

FLOX every 2nd week Cetuximab weekly

C

FLOX given intermittently and maintenance cetuximab

Group Type EXPERIMENTAL

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

Intervention Type DRUG

FLOX every 2nd week for 8 cycles. Stop of FLOX until progression then FLOX is reintroduced.

Cetuximab weekly.

Interventions

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FLOX (5-fluorouracil/folinic acid/oxaliplatin)

FLOX every 2nd week

Intervention Type DRUG

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

FLOX every 2nd week Cetuximab weekly

Intervention Type DRUG

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.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No