Biweekly docetaxel, cisplatin, and 5-fluorouracil (DCF) chemotherapy for advanced esophageal squamous cell carcinoma: a phase I dose-escalation study

Cancer Chemother Pharmacol. 2010 Nov;66(6):1159-65. doi: 10.1007/s00280-010-1447-1. Epub 2010 Sep 28.


Background and purpose: The optimal chemotherapeutic protocol for the treatment of esophageal cancer has not yet been established. A dose-escalation study of docetaxel combined with cisplatin and 5-fluorouracil (5-FU) was performed to determine the optimal dose in patients with advanced esophageal squamous cell carcinoma.

Patients and method: We studied a total of 18 patients who had previously untreated thoracic esophageal squamous cell carcinoma with T4 tumors and/or metastasis. The patients received an infusion of docetaxel at different dose levels (levels 1, 2, 3: 30, 35, 40 mg/m(2), respectively) and an infusion of cisplatin (40 mg/m(2)) on days 1 and 15 plus a continuous infusion of 5-FU (400 mg/m(2)/day) on days 1-5 and 15-19.

Results: Dose-limiting toxicities (DLT) included febrile neutropenia and leukopenia. DLT occurred in 2 of 6 patients at level 1, 2 and in 3 of 6 patients at level 3. The response rate was 88.9%, including a complete response rate of 33.3%.

Conclusions: To minimize toxicity and maximize dose intensity, we elected to investigate a biweekly regimen. The maximum tolerated dose was level 3, and the recommended dose was determined to be docetaxel 35 mg/m(2) with cisplatin 40 mg/m(2) plus 5-FU 400 mg/m(2), administered biweekly. This regimen was tolerable and highly active. A phase II study has been started.

Publication types

  • Clinical Trial, Phase I

MeSH terms

  • Adult
  • Aged
  • Antineoplastic Combined Chemotherapy Protocols / administration & dosage*
  • Carcinoma, Squamous Cell / drug therapy*
  • Carcinoma, Squamous Cell / secondary
  • Cisplatin / administration & dosage
  • Docetaxel
  • Dose-Response Relationship, Drug
  • Drug Administration Schedule
  • Esophageal Neoplasms / drug therapy*
  • Esophageal Neoplasms / pathology
  • Female
  • Fluorouracil / administration & dosage
  • Humans
  • Male
  • Maximum Tolerated Dose
  • Middle Aged
  • Taxoids / administration & dosage
  • Treatment Outcome


  • Taxoids
  • Docetaxel
  • Cisplatin
  • Fluorouracil