This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Cetuximab and Combination Chemotherapy in Treating Patients With Advanced or Metastatic Colorectal Cancer

This study has been completed.
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: November 15, 2007
Last updated: May 12, 2011
Last verified: May 2011

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 Intervention Phase
Colorectal Cancer Biological: cetuximab Drug: fluorouracil Drug: irinotecan hydrochloride Drug: leucovorin calcium Other: pharmacological study Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

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

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

Estimated Enrollment: 80
Study Start Date: October 2005
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
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.


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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00559741

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

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00559741     History of Changes
Other Study ID Numbers: CDR0000574065
Study First Received: November 15, 2007
Last Updated: May 12, 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 processed this record on September 21, 2017