A phase I trial of definitive chemoradiotherapy with docetaxel, cisplatin, and 5-fluorouracil (DCF-R) for advanced esophageal carcinoma: Kitasato digestive disease & oncology group trial (KDOG 0501).

Abstract

A dose-escalation study of docetaxel combined with cisplatin, 5-fluorouracil, and concurrent radiotherapy (DCF-R) was performed to determine the optimal dose in patients with advanced esophageal carcinoma. A total of 19 patients who had previously untreated thoracic esophageal carcinoma with T4 tumors and/or M1 lymph-node metastasis were studied. The Patients received an infusion of docetaxel (levels 1, 2, 3, 2.5: 20, 30, 40, 35 mg/m(2)) and an infusion of cisplatin (40 mg/m(2)) on days 1, 15, 29, and 43 plus a continuous infusion of 5-fluorouracil (400mg/m(2)/day) on days 1-5, 15-19, 29-33, and 43-47. And patients received 61.2 Gy/34 fractions/7 weeks of concurrent radiotherapy. Dose-limiting toxicities (DLTs) were febrile neutropenia and grade 4 leukopenia lasting 3 days. DLT occurred in 2 of 6 patients at level 2, 3 of 4 patients at level 3, and 2 of 6 patients at level 2.5. The main toxicities were myelotoxicity and esophagitis. The overall response rate was 89.5%, including a complete response rate of 42.1%. The maximum-tolerated dose was level 3, because 50% or more of the patients had DLTs. Therefore, level 2.5 was recommended for phase II studies. This regimen was tolerable and highly active.