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

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.

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Key information

Conditions

Colon Cancer Allergic Reaction Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Cancer Head and Neck Neoplasms Hypersensitivity Immune System Diseases Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU, Amiens, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

blood sample

Other

The IgE anti cetuximab test will then be conducted by an ELISA test

Primary outcomes

Validate the utility of an IgE anti-cetuximab test in the treatment strategy

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Centre Francois Baclesse

Other

Collaborators

University Hospital, Caen

Registry information

Acronym: IgES

Important dates

Study start: 2010
Primary completion: 2013
Study completion: 2013
First posted: Sep 19, 2011
Registry last updated: Mar 8, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed