drugset / Trial / NCT01289522
Chemotherapy With Cetuximab in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
Phase 2
Completed
54 enrolled
Groupe Oncologie Radiotherapie Tete et Cou
Gustave Roussy, Cancer Campus, Grand Paris · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cetuximab | Monoclonal antibody | 500 mg/m2 | Intravenous |