Cetuximab, fluorouracil (5-FU), cisplatin, and docetaxel as first-line treatment in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN): Interim results of a randomized phase II clinical trial (CeFCiD).

e17021 Background: This study investigates efficacy and toxicity of docetaxel added to cetuximab, cisplatin and 5-FU for patients with R/M SCCHN. We here report a planned second interim analysis to compare response rates between arms in order to decide on continuing to full accrual. Methods: Inclusion criteria were: stage III/IV R/M SCCHN and ECOG 0-1. Patients were randomized to arm A: cetuximab (standard dose) plus a maximum of 6 cycles of docetaxel (40 mg/m², day 1+8), cisplatin (40 mg/m², day 1+8) and 5-FU (2000 mg/m², day 1+8) or to arm B: cetuximab (standard dose), cisplatin (100 mg/m², day 1) and 5-FU (1000 mg/m², day 1-4). Treatment was administered until progression or intolerabil…