Induction Chemotherapy With Cetuximab, Docetaxel, Cisplatin, and Fluorouracil (ETPF)for Squamous Cell Carcinoma of the Oropharynx That is Operable Stage III-IV
- To determine the complete clinical response rate at 3 months in patients with stage III
or IV nonmetastatic squamous cell carcinoma of the oropharynx treated with cetuximab,
docetaxel, cisplatin, and fluorouracil.
- To determine the rate of tumor response.
- To determine progression-free and overall survival.
- To determine the rate of complete pathological response.
- To assess the tolerability of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive cetuximab IV over 1-2 hours on days 1, 8, and 15; docetaxel IV over 1 hour
and cisplatin IV over 1 hour on day 1; and fluorouracil IV continuously on days 1-5.
Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or
After completion of study therapy, patients are followed every 2 months for 1 year and every
3 months for 2 years.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Complete clinical response rate at 3 months
at 3 months
Jean Lacau Saint Guily, MD
France: Committee of the Protection of the Persons