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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00556413
Recruitment Status : Completed
First Posted : November 12, 2007
Last Update Posted : May 16, 2011
Information provided by:
National Cancer Institute (NCI)

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Biological: cetuximab Drug: fluorouracil Drug: irinotecan hydrochloride Drug: leucovorin calcium Drug: oxaliplatin Phase 2

Detailed Description:



  • 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.


  • 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 39 participants
Allocation: Non-Randomized
Primary Purpose: Treatment
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
Study Start Date : September 2005
Actual Primary Completion Date : May 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Cetuximab

Primary Outcome Measures :
  1. Complete response rate

Secondary Outcome Measures :
  1. Objective response rate
  2. Tolerability
  3. Time to response
  4. Time to progression
  5. Survival

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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


  • 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


  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00556413

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Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, France, 34298
Sponsors and Collaborators
Institut du Cancer de Montpellier - Val d'Aurelle
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Study Chair: Marc Ychou, MD, PhD Institut du Cancer de Montpellier - Val d'Aurelle
Layout table for additonal information Identifier: NCT00556413    
Other Study ID Numbers: CDR0000574149
First Posted: November 12, 2007    Key Record Dates
Last Update Posted: May 16, 2011
Last Verified: May 2011
Keywords provided by National Cancer Institute (NCI):
stage IV colon cancer
stage IV rectal cancer
recurrent colon cancer
recurrent rectal cancer
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors