An Observational Study to Evaluate the Safety and Efficacy of Cetuximab in Combination With Platinum-based Chemotherapy in the First-line Treatment of Recurrent or Metastatic Squamous Cell Carcinoma of Head and Neck

Merck KGaA (EMD Serono)

Status: Terminated

Conditions: Carcinoma, Squamous Cell

Treatments: Drug: Cetuximab

Study type: Observational

Funder types: Industry

Identifiers

NCT01142869

EMR 062202-514

Details and patient eligibility

About

The aim of this prospective, observational, multicenter, post-marketing study is to evaluate the safety and efficacy of Cetuximab (Erbitux) in combination with platinum based chemotherapy, in the first line therapy of recurrent/ metastatic squamous cell carcinoma of head and neck (SCCHN). A total of 100 subjects with SCCHN will be recruited in 20 centres across India.

Enrollment: 133 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• The study inclusion criteria is as per the label for patients with metastatic/recurrent SCCHN approved by India Health Authorities, i.e., "Cetuximab is indicated for the treatment of patients with squamous cell cancer of the head and neck in combination with platinum-based chemotherapy for recurrent and/or metastatic disease."
• For each platinum-based chemotherapy, the related product labels approved by India Health Authorities will also be followed strictly in terms of patient eligibility.

Exclusion criteria

• Patients with known severe (grade 3 or 4; National Cancer Institute-Common Toxicity Criteria [NCI-CTC]) hypersensitivity reactions to Cetuximab are contraindicated for Cetuximab