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Colorectal CancerPhase 2NCT00556413

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

A Phase 2 study testing cetuximab, fluorouracil and irinotecan hydrochloride in people with Colorectal Cancer, run by Institut du Cancer de Montpellier - Val d'Aurelle at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Colorectal Cancer
What is being tested?
cetuximab, fluorouracil and irinotecan hydrochloride
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
1 siteFrance
Study dates
Sep 2005to 17 Nov 2011
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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)

Trial locations and contacts

1 site in 1 country.

France1 site

  • Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

    Montpellier, 34298

Other trials in France

About this study

Official title: 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.

Read the 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.

Keywords
stage IV colon cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer
Medical subject headings
Colorectal Neoplasms, Colonic Neoplasms, Rectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00556413
Study groupRoleWhat they receive
ERBIRINOXExperimental5FU + Irinotecan + Oxaliplatine + Cetuximab
Receives: Biological: cetuximab; Drug: fluorouracil; Drug: irinotecan hydrochloride; Drug: leucovorin calcium; Drug: oxaliplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Complete response rate

    Measured: 6 months

Secondary outcomes (5)

  1. Objective response rate

    Measured: 6 months

  2. Adverse events by using NCI-CTC

    Measured: 6 months

  3. Time to response

    Measured: 6 months

  4. Time to progression

    Measured: 6 months

  5. Survival

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Nov 2007 (estimated)
  2. Study startSep 2005
  3. Primary completionMay 2011
  4. Study completion17 Nov 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00556413
Sponsor's protocol ID
CDR0000574149
Other IDs
CLCC-ERBIRINOX, INCA-RECF0288, EUDRACT-2005-004746-13, MERCK-CLCC-ERBIRINOX
Status last verified
Feb 2026
First submitted
9 Nov 2007
Last updated
5 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Assenat E, Desseigne F, Thezenas S, Viret F, Mineur L, Kramar A, Samalin E, Portales F, Bibeau F, Crapez-Lopez E, Bleuse JP, Ychou M. Cetuximab plus FOLFIRINOX (ERBIRINOX) as first-line treatment for unresectable metastatic colorectal cancer: a phase II trial. Oncologist. 2011;16(11):1557-64. doi: 10.1634/theoncologist.2011-0141. Epub 2011 Oct 20.

    PubMed 22016477

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing cetuximab, fluorouracil and irinotecan hydrochloride in people with Colorectal Cancer, run by Institut du Cancer de Montpellier - Val d'Aurelle at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete response rate (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00556413, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.

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