drugset / Trial / NCT01289522

Chemotherapy With Cetuximab in Treating Patients With Recurrent or Metastatic Head and Neck Cancer

NCT01289522 ↗

NaSingle-groupOpen-labelTreatment

Summary

PURPOSE: Cetuximab with platinum and 5FU is now the standard combination as first-line treatment in patients with metastatic or recurrent Head and Neck squamous cell carcinomas. Cetuximab and taxane combinations have demonstrated promising activity in Head and Neck cancer. This phase II trial is studying new cetuximab, docetaxel and cisplatin combination named TPEx as first-line treatment in this setting.

Timeline

Start
2009-09
Primary completion
2014-01
Completion
2014-01

Outcome

Met primary endpoint

paper The primary end point was met with an ORR of 44.4% (95% CI 30.9-58.6). PMID 26109631 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Cetuximab Monoclonal antibody 500 mg/m2 Intravenous