A Post-marketing Surveillance Study on Erbitux in Combination With Platinum-based Chemotherapy in Metastatic/Recurrent Squamous Cell Cancer of the Head and Neck
A Post-marketing Surveillance Study on Erbitux in Combination With Platinum-based Chemotherapy in Metastatic/Recurrent Squamous Cell Cancer of the Head and Neck
This is a prospective post-marketing surveillance (PMS) study to collect safety information
 from more than 600 subjects with recurrent and/or metastatic squamous cell cancer of the head
 and neck (SCCHN) treated with Erbitux as final evaluable cases. This PMS study is requested
 by the Korean Regulatory Authorities. After approval of new indication in Korea, there is a
 requirement to investigate more than 600 subjects during six years, to continue monitoring
 and provide further information about safety and toxicity in clinical practice.
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.

 OBJECTIVES

 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.