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Assessing the Value of a Dosage of Anti-cetuximab in the Therapeutic Management of Patients With Colon Cancer or Upper Aero-digestive Tract and Candidates for Treatment With Cetuximab (IgES)

This study has been completed.
Sponsor:
Collaborator:
University Hospital, Caen
Information provided by (Responsible Party):
Centre Francois Baclesse
ClinicalTrials.gov Identifier:
NCT01436617
First received: September 14, 2011
Last updated: March 7, 2013
Last verified: March 2013
History of Changes
  Purpose

The main objective of this study is to validate the utility of IgE anti-cetuximab in the treatment strategy to identify patients at risk for a severe allergic reaction to cetuximab (grade 3 or 4 of the classification of NCI) and thus reduce the incidence of severe reactions.


Condition Intervention Phase
Colon Cancer
Head and Neck Cancer
Allergic Reaction
 Other: blood sample
 Phase 2

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Assessing the Value of a Dosage of Anti-cetuximab in the Therapeutic Management of Patients With Colon Cancer or Upper Aero-digestive Tract and Candidates for Treatment With Cetuximab

Resource links provided by NLM:

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

Further study details as provided by Centre Francois Baclesse:

Primary Outcome Measures:
  • Validate the utility of an IgE anti-cetuximab test in the treatment strategy [ Time Frame: 3 years ] [ Designated as safety issue: No ]

    We hypothesize that a positive specific IgE assay predicts the occurrence of an allergic reaction during the first dose of cetuximab. Thus, in population areas where the prevalence of specific IgE positive plasma is higher, the use of alternative therapies in patients with a positive test would reduce the incidence of anaphylactic reactions to cetuximab.

    If the use of specific IgE anti-cetuximab in the treatment strategy is effective, there will be reduction in the incidence of anaphylaxis to cetuximab in the participating centers.



Enrollment: 303
Study Start Date: January 2010
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: blood sample
    The IgE anti cetuximab test will then be conducted by an ELISA test
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with colon cancer or upper aero-digestive tract and candidates for treatment with cetuximab

Criteria

Inclusion Criteria:

  • Patient informed consent,
  • Patient aged over 18 years
  • Patients with a WHO performance status ≤ 2,
  • Colon cancer or upper aero-digestive tract cytologically or histologically proven
  • Patients with an indication to the theoretical use of cetuximab for colon neoplasia or upper aero-digestive tract,
  • Haematological and biochemical compatible with combination therapy with cetuximab.

Exclusion Criteria:

  • Patients previously treated with cetuximab,
  • A person deprived of liberty or under supervision.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01436617

Locations
France
CHU
Amiens, France, 80054
Centre hospitalier
Bayeux, France, 14400
CHU
Caen, France, 14033
Centre François Baclesse
Caen, France, 14076
Centre Georges-François Leclerc
Dijon, France, 21079
CHRU Lille
Lille, France, 59037
Centre Oscar Lambret
Lille, France, 59020
CHU Charles Nicolle
Rouen, France, 76000
Centre Henri Becquerel
Rouen, France, 76038
Centre Paul Strauss
Strasbourg, France, 67065
Sponsors and Collaborators
Centre Francois Baclesse
University Hospital, Caen
Investigators
Principal Investigator: GERVAIS Radj, MD Centre François Baclesse
  More Information

No publications provided

Responsible Party: Centre Francois Baclesse
ClinicalTrials.gov Identifier: NCT01436617     History of Changes
Other Study ID Numbers: IgES
Study First Received: September 14, 2011
Last Updated: March 7, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre Francois Baclesse:
cancer
colon
Head and neck
cetuximab
anti-cetuximab dosage

Additional relevant MeSH terms:
Colonic Neoplasms
Head and Neck Neoplasms
Hypersensitivity
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Immune System Diseases
Cetuximab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013