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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Colon Cancer, Head and Neck Cancer, Allergic Reaction

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Trial Information

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


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.

Type of Study:

Observational

Study Design:

Time Perspective: Prospective

Outcome Measure:

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

Outcome Description:

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.

Outcome Time Frame:

3 years

Safety Issue:

No

Principal Investigator

GERVAIS Radj, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Centre François Baclesse

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

IgES

NCT ID:

NCT01436617

Start Date:

January 2010

Completion Date:

March 2013

Related Keywords:

  • Colon Cancer
  • Head and Neck Cancer
  • Allergic Reaction
  • cancer
  • colon
  • Head and neck
  • cetuximab
  • anti-cetuximab dosage
  • Colonic Neoplasms
  • Head and Neck Neoplasms
  • Hypersensitivity

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