A Post-marketing Surveillance Study on Erbitux in Combination With Platinum-based Chemotherapy in Metastatic/Recurrent Squamous Cell Cancer of the Head and Neck

NCT01075841 | Withdrawn

• 1 other identifier: EMR 62241-510
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Neoplasms, Squamous Cell

Keywords

Head and neck neoplasms; Carcinoma, squamous cell; Cetuximab

Outcome Measures

Primary Outcomes (1)

• Safety

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

  After approval of new indication till 6 years of PMS period

Secondary Outcomes (1)

• Efficacy

  Throughout 6 years of PMS period

Interventions

Cetuximab DRUG

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.

Also known as: Erbitux

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

Sponsors & Collaborators

• Merck KGaA, Darmstadt, Germany: lead

MeSH Terms

Conditions

Neoplasms, Squamous Cell; Head and Neck Neoplasms; Carcinoma, Squamous Cell

Interventions

Cetuximab

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 24, 2010
• First Posted: February 25, 2010
• Study Start: March 1, 2009
• Primary Completion: March 1, 2009
• Last Updated: July 2, 2014

Record last verified: 2010-12