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New cocktail shows promise against spread colon cancer

NCT ID NCT00556413

Disease control Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a combination of the targeted drug cetuximab with a strong chemotherapy cocktail (FOLFIRINOX) as a first treatment for people whose colorectal cancer had spread and could not be removed by surgery. The goal was to see if this mix could shrink tumors better than standard care. The trial included 42 patients, and researchers measured how many had a complete response, side effects, and how long they lived.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

42 people

The number who actually took part.

Start date

Sep 2005

Finished

Nov 2011

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

colonic neoplasm colorectal cancer colorectal neoplasm rectal neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Colorectal cancer

Contacts and locations

Locations

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

    Montpellier, 34298, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.