Cetuximab and Combination Chemotherapy in Treating Patients With Advanced or 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: NCT00559741
Recruitment Status : Completed
First Posted : November 16, 2007
Last Update Posted : May 13, 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, such as irinotecan, fluorouracil, and leucovorin, 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 in treating patients with advanced or metastatic colorectal cancer.

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

Detailed Description:



  • Improve hematologic and gastrointestinal tolerance to cetuximab and irinotecan hydrochloride, fluorouracil, and leucovorin calcium (FOLFIRI) in patients with advanced or metastatic colorectal cancer.


  • Increase the effectiveness of this regimen by intensifying the treatment.
  • Specify the constitutional genetic and genomic tumor parameters that could interfere with and predict the toxicity and/or antitumor efficacy of this regimen.
  • Assess the time to progression.

OUTLINE: This is a multicenter study.

Patients receive irinotecan hydrochloride IV over 90 minutes, leucovorin calcium IV over 2 hours, and cetuximab IV over 1-2 hours on day 1. Patients also receive fluorouracil IV continuously over 46 hours on days 1 and 2. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity.

Pharmacokinetic and pharmacogenetic studies are also conducted.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 Study to Improve Tolerance of Chemotherapy Involving Cetuximab and Multidrug FOLFIRI, With Pharmacokinetic and Pharmacogenetic Studies, in Patients With Metastatic Colorectal Cancer
Study Start Date : October 2005
Primary Completion Date : May 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Cetuximab
U.S. FDA Resources

Primary Outcome Measures :
  1. Improvement of hematologic and gastrointestinal tolerance to therapy

Secondary Outcome Measures :
  1. Efficacy
  2. Genetic and genomic tumor parameters that could interfere with and predict the toxicity and/or antitumor efficacy of therapy
  3. Time to progression

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed colorectal cancer

    • Advanced or metastatic disease
  • Scheduled to receive first- or second-line therapy for metastatic disease
  • No cerebral metastases or symptomatic or uncontrolled meningeal disease


  • WHO performance status 0-2
  • ANC ≥ 2,000/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Total bilirubin ≤ 2 times upper limit of normal (ULN)
  • AST and ALT ≤ 3 times ULN
  • Alkaline phosphatase ≤ 5 times ULN
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No intestinal blockage
  • No complete dihydropyrimidine dehydrogenase deficiency
  • No chronic inflammatory disease of the colon
  • No other cancer except for nonmelanoma skin cancer or curatively treated carcinoma of the cervix or breast
  • No other severe condition, or condition that is likely to worsen, including any of the following:

    • Unstable heart disease
    • Myocardial infarction within the past 6 months
    • Active uncontrolled infection
  • No contraindication to atropine


  • See Disease Characteristics
  • Recovered from prior anticancer therapy
  • More than 4 weeks since prior and no other concurrent investigational therapy
  • Prior adjuvant chemotherapy allowed
  • No prior fluorouracil or irinotecan hydrochloride
  • No other concurrent anticancer therapy

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): NCT00559741

Centre Paul Papin
Angers, France, 49036
Sponsors and Collaborators
ICO Paul Papin
Study Chair: Erick Gamelin, MD ICO Paul Papin

Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00559741     History of Changes
Other Study ID Numbers: CDR0000574065
First Posted: November 16, 2007    Key Record Dates
Last Update Posted: May 13, 2011
Last Verified: May 2011

Keywords provided by National Cancer Institute (NCI):
stage IV colon cancer
recurrent colon cancer
stage IV rectal cancer
recurrent rectal cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Protective Agents