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

Completed

• Conditions: Colon Cancer; Head and Neck Cancer; Allergic Reaction

• Registration Number: NCT01436617
• Lead Sponsor: Centre Francois Baclesse

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2011-09-14
• Study First Submitted QC: 2011-09-16
• Study First Posted: 2011-09-19
• Status Verified: 2013-03
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Last Update Submitted: 2013-03-07
• Last Update Posted: 2013-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 303

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Validate the utility of an IgE anti-cetuximab test in the treatment strategy	3 years	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.

Trial Locations

Locations (9)

Centre hospitalier; 🇫🇷 Bayeux, France

Centre Oscar Lambret; 🇫🇷 Lille, France

CHU Charles Nicolle; 🇫🇷 Rouen, France

Centre Henri Becquerel; 🇫🇷 Rouen, France

Centre Georges-François Leclerc; 🇫🇷 Dijon, France

Centre François Baclesse; 🇫🇷 Caen, France

CHU; 🇫🇷 Caen, France

CHRU Lille; 🇫🇷 Lille, France

Centre Paul Strauss; 🇫🇷 Strasbourg, France