Allergic Reaction, Colon Cancer, Head and Neck Cancer
Conditions
Keywords
cancer, colon, Head and neck, cetuximab, anti-cetuximab dosage
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.
Interventions
OTHERblood sample
The IgE anti cetuximab test will then be conducted by an ELISA test
Sponsors
University Hospital, Caen
Centre Francois Baclesse
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
France
Outcome results
None listed