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This study has been withdrawn prior to enrollment.
(After loss of orphan drug status in Korea, study was withdrawn due to Regulatory Authority request. Patients will be enrolled into NCT01075828 instead.)
Sponsor:
Information provided by:
Merck KGaA
ClinicalTrials.gov Identifier:
NCT01075841
First received: February 24, 2010
Last updated: July 1, 2014
Last verified: December 2010
  Purpose

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.


Condition Intervention
Neoplasms, Squamous Cell
Drug: Cetuximab

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Korean Post-Marketing Surveillance Study On Erbitux (Cetuximab) In Patients With Recurrent And/Or Metastatic Squamous Cell Carcinoma Of The Head And Neck

Resource links provided by NLM:


Further study details as provided by Merck KGaA:

Primary Outcome Measures:
  • Safety [ Time Frame: After approval of new indication till 6 years of PMS period ] [ Designated as safety issue: Yes ]
    Frequency and severity of all adverse events (AEs), regardless of the causal relationship to Erbitux


Secondary Outcome Measures:
  • Efficacy [ Time Frame: Throughout 6 years of PMS period ] [ Designated as safety issue: No ]
    Best tumour response; time to progression; and duration of tumor response


Enrollment: 0
Study Start Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Cetuximab
    Subjects who are eligible for Erbitux treatment according to the indication in the national label of Erbitux (i.e. where Erbitux is used in combination with platinum-based therapy for the treatment of subjects with recurrent and/or metastatic SCCHN) 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.
    Other Name: Erbitux
Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subjects with recurrent and/or metastatic SCCHN undergoing treatment with Erbitux in Korea.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Head of Medical Department, Merck Serono Korea, an affiliate of Merck KGaA, Darmstadt, Germany
ClinicalTrials.gov Identifier: NCT01075841     History of Changes
Other Study ID Numbers: EMR 62241-510
Study First Received: February 24, 2010
Last Updated: July 1, 2014
Health Authority: Korea: Food and Drug Administration

Keywords provided by Merck KGaA:
Head and neck neoplasms
Carcinoma, squamous cell
Cetuximab

Additional relevant MeSH terms:
Neoplasms
Carcinoma, Squamous Cell
Neoplasms, Squamous Cell
Head and Neck Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms by Site
Cetuximab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 28, 2014