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
• 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

• Allergic Reaction
• Colon Cancer
• Head and Neck Cancer
• Head and Neck Neoplasms
• Hypersensitivity

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