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NCT01436617 Clinical Trial

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

Head and Neck Cancer Clinical Trial

— IgES  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01436617
Other study ID # IgES
Secondary ID
Status Completed
Phase Phase 2
First received September 14, 2011
Last updated March 7, 2013
Start date January 2010
Est. completion date March 2013

Study information
Verified date March 2013
Source Centre Francois Baclesse
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 303
Est. completion date March 2013
Est. primary completion date March 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Other:
• blood sample
The IgE anti cetuximab test will then be conducted by an ELISA test

Locations
Country Name City State
France CHU Amiens
France Centre hospitalier Bayeux
France Centre François Baclesse Caen
France CHU Caen
France Centre Georges-François Leclerc Dijon
France Centre Oscar Lambret Lille
France CHRU Lille Lille
France Centre Henri Becquerel Rouen
France CHU Charles Nicolle Rouen
France Centre Paul Strauss Strasbourg

Sponsors (2)
Lead Sponsor Collaborator
Centre Francois Baclesse University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Validate the utility of an IgE anti-cetuximab test in the treatment strategy 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.		 3 years No
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