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A Korean Post-Marketing Surveillance Study On Erbitux (Cetuximab) In Patients With Recurrent And/Or Metastatic Squamous Cell Carcinoma Of The Head And Neck

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Neoplasms, Squamous Cell

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Trial Information

A Korean Post-Marketing Surveillance Study On Erbitux (Cetuximab) In Patients With Recurrent And/Or Metastatic Squamous Cell Carcinoma Of The Head And Neck

The PMS study is planned to be conducted within 6 years from the approval date of the new
indication in approximately 50 institutions in Korea.


Primary objective:

- To obtain safety information on the use of Erbitux in subjects with recurrent and/or
metastatic SCCHN in terms of frequency and severity of adverse events (AEs)

Secondary objectives:

- To gather clinical efficacy information of the treatment

During the PMS period, each subject's background, subject's medical history (surgery,
anti-cancer treatment), Erbitux treatment status, concurrent medication, response
evaluation, status and reason of discontinuation, all AEs (regardless of the causal
relationship to Erbitux), and abnormal results of laboratory tests will be collected. The
PMS will be based on all cases treated with Erbitux at least once.

Erbitux will be prescribed to recurrent and/or metastatic SCCHN subjects according to the
approved national label as in routine clinical practice under the supervision of an
investigator experienced in the use of antineoplastic medicinal products. Prior to the
first infusion, subjects will receive pre-medication with an antihistamine and a
corticosteroid. The initial dose of Erbitux is 400 mg/m2 body surface area and the
subsequent weekly doses are 250 mg/m2 each administered intravenously via in-line filtration
with an infusion pump, gravity drip, or a syringe pump. The recommended infusion period for
the initial dose is 120 minutes and for the subsequent weekly doses is 60 minutes with the
maximum infusion rate not exceeding 10 mg/min, equivalent to 5 ml/min of Erbitux 2 mg/ml or
2ml/min of Erbitux 5mg/mL.

Inclusion Criteria:

- Subjects who are eligible for Erbitux treatment according to the indication in the
national label of Erbitux. The national label approved by Korea Food & Drug
Administration is "Erbitux in combination with radiation therapy is indicated for the
treatment of subjects with metastatic/recurrent SCCHN.

Type of Study:


Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:


Outcome Description:

Frequency and severity of all adverse events (AEs), regardless of the causal relationship to Erbitux

Outcome Time Frame:

After approval of new indication till 6 years of PMS period

Safety Issue:



Korea: Food and Drug Administration

Study ID:

EMR 62241-510



Start Date:

March 2009

Completion Date:

October 2014

Related Keywords:

  • Neoplasms, Squamous Cell
  • Head and neck neoplasms
  • Carcinoma, squamous cell
  • Cetuximab
  • Neoplasms
  • Carcinoma, Squamous Cell
  • Neoplasms, Squamous Cell
  • Head and Neck Neoplasms