Cetuximab and Combination Chemotherapy as First-Line Therapy in Treating Patients With Metastatic Colorectal Cancer

February 3, 2026 updated by: Institut du Cancer de Montpellier - Val d'Aurelle

Phase II Study Evaluating the Efficacy and Safety of cétuximab Associated With the Protocol FOLFIRINOX (LV5FU Simplified Combined With Irinotecan and Oxaliplatin) in the First Line Treatment in Patients With Metastatic Colorectal Cancer Expressing EGFR or Not

RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving cetuximab together with combination chemotherapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving cetuximab together with combination chemotherapy works as first-line therapy in treating patients with metastatic colorectal cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

Primary

  • Determine the complete response rate in patients with metastatic colorectal cancer treated with cetuximab and FOLFIRINOX chemotherapy comprising oxaliplatin, irinotecan hydrochloride, leucovorin calcium, and fluorouracil as first-line therapy.

Secondary

  • Determine the objective response rate in patients treated with this regimen.
  • Assess the tolerability of this regimen in these patients.
  • Determine the time to response and time to progression in patients treated with this regimen.
  • Determine the survival of patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive cetuximab IV over 1-2 hours on days 1 and 8. Patients also receive FOLFIRINOX chemotherapy comprising oxaliplatin IV over 2 hours, irinotecan hydrochloride IV over 30-90 minutes, and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV continuously over 46 hours on days 1 and 2. Treatment repeats every 15 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months.

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34298
        • Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

DISEASE CHARACTERISTICS:

  • Histologically confirmed colorectal cancer

    • Metastatic, unresectable disease
  • May or may not express the EGFR gene

  • Measurable disease, defined as ≥ 1 measurable lesion by MRI or CT scan

    • Lesion must be outside an irradiated area

PATIENT CHARACTERISTICS:

  • WHO performance status 0-1
  • Life expectancy > 3 months
  • ANC ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Hemoglobin ≥ 9 g/dL
  • Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • Transaminases ≤ 2.5 times ULN (5 times ULN if hepatic metastases are present)
  • Creatinine ≤ 1.5 times ULN
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No peripheral or symptomatic neuropathy ≥ grade 2 (NCI-CTCAE)
  • No complete or partial intestinal blockage
  • No intestinal inflammatory disease (e.g., Crohn's disease or ulcerative colitis)
  • No chronic diarrhea
  • No severe unstable cardiac disease (despite treatment)
  • No myocardial infarction within the past 6 months
  • No neurological or psychiatric illness, including epilepsy or dementia
  • No uncontrolled active infection
  • No other prior or concurrent malignancy within the past 5 years except for curatively treated basal cell skin cancer
  • No psychological, familial, social, or geographic reason that would preclude study follow-up

PRIOR CONCURRENT THERAPY:

  • No prior chemotherapy for metastatic disease

    • Prior fluorouracil-based adjuvant chemotherapy allowed provided it was administered ≥ 4 weeks ago
  • At least 4 weeks since prior and no other concurrent experimental therapy
  • No prior irinotecan hydrochloride, oxaliplatin, or monoclonal antibody
  • No prior intestinal resection (e.g., hemicolectomy or extended resection of the small intestine)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ERBIRINOX
5FU + Irinotecan + Oxaliplatine + Cetuximab
Drug: fluorouracil
Drug: leucovorin calcium
Drug: irinotecan hydrochloride
Drug: oxaliplatin
Biological: cetuximab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Complete response rate
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Survival
Time Frame: 6 months
6 months
Objective response rate
Time Frame: 6 months
6 months
Time to progression
Time Frame: 6 months
6 months
Adverse events by using NCI-CTC
Time Frame: 6 months
6 months
Time to response
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

Investigators

  • Study Chair: Marc Ychou, MD, PhD, Institut du Cancer de Montpellier - Val d'Aurelle

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

November 17, 2011

Study Registration Dates

First Submitted

November 9, 2007

First Submitted That Met QC Criteria

November 9, 2007

First Posted (Estimated)

November 12, 2007

Study Record Updates

Last Update Posted (Actual)

February 5, 2026

Last Update Submitted That Met QC Criteria

February 3, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000574149
  • CLCC-ERBIRINOX
  • INCA-RECF0288
  • EUDRACT-2005-004746-13
  • MERCK-CLCC-ERBIRINOX

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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