Phase I Study of Docetaxel, Cisplatin, and 5-Fluorouracil Chemoradiotherapy for Local or Metastatic Esophageal Cancer.

Objective: Chemoradiotherapy outcomes for unresectable esophageal cancer remain poor. We designed a phase I study of docetaxel, cisplatin (CDDP), and 5-fluorouracil (5-FU) chemoradiotherapy.

Methods: Patients with T4 or M1 esophageal squamous cell carcinoma were enrolled. They received 2 chemotherapy cycles every 4 weeks with these initial doses (Phase I): docetaxel and CDDP (50 mg/m(2), days 1 and 29) with continuous 5-FU infusion (600 mg/m(2)/day, days 1-5 and 29-33). Concurrent radiotherapy (60 Gy) was initiated on day 1. Docetaxel and CDDP plus 5-FU doses were increased to 60 mg/m(2) plus 800 mg/m(2)/day.

Results: Out of the 15 patients enrolled, 13 completed the treatment. The MTDs were as follows: docetaxel (60 mg/m(2)), CDDP (60 mg/m(2)), and 5-FU (800 mg/m(2)/day). The overall response rate was 73%, with 27% achieving complete responses.

Conclusions: In this phase I trial, docetaxel (60 mg/m(2)), CDDP (60 mg/m(2)), and 5-FU (600 mg/m(2)/day) were considered as the tolerable and active doses. These are the recommended doses for a future phase II trial.