NCT01142869

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

An Observational Study to Evaluate the Safety and Efficacy of Cetuximab in Combination With Platinum-based Chemotherapy, in the First-line Therapy of Recurrent/ Metastatic Squamous Cell Carcinoma of Head and Neck (SCCHN)

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 133 (actual)
• Sponsor: Merck KGaA, Darmstadt, Germany · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Carcinoma, Squamous Cell

Interventions

Type	Name	Description
DRUG	Cetuximab	The starting dose will be intravenous (IV) cetuximab 400 mg/m2 body surface area administered as a 120-minute infusion once a week . The subsequent weekly doses will be IV cetuximab 250 mg/m2 administered as a 60-minute infusion. The maximum infusion rate must not exceed 10 mg/min.

Timeline

• Start date: 2009-12-31
• Primary completion: 2013-07-31
• Completion: 2014-08-05
• First posted: 2010-06-11
• Last updated: 2017-05-08

Locations

28 sites across 1 country: India