title: Phase I Study of Docetaxel Plus Nedaplatin in Patients With Metastatic or Recurrent Esophageal Squamous Cell Carcinoma After Cisplatin Plus 5-Fluorouracil Treatment.
abstract: OBJECTIVE
  To date, no second-line chemotherapy regimen for esophageal squamous cell carcinoma (SCC) has been established. This clinical trial aimed to assess the optimum dose of docetaxel plus nedaplatin (cis-diammine-glycolate platinum) as second-line chemotherapy.
  
  
  METHODS
  Patients with metastatic or recurrent esophageal SCC after treatment with cisplatin plus 5-fluorouracil received docetaxel (50 or 60 mg/m) plus nedaplatin (70 mg/m²) on day 1 every 4 weeks. The recommended dose was based on dose-limiting toxicities defined during the first cycle.
  
  
  RESULTS
  From February 2009 to November 2011, 9 patients were enrolled in the study. Their median age was 62 years (range, 58 to 72 y). Six patients had undergone radiotherapy and 4 had undergone surgical resection of primary lesions. Dose-limiting toxicities were observed in 2 patients at dose level 1 (60 mg/m² docetaxel, 70 mg/m² nedaplatin) but not at dose level 0 (50 mg/m² docetaxel, 70 mg/m nedaplatin). Thus, the maximum tolerated dose was established at dose level 1. No severe nonhematological toxicity was observed. No patient achieved complete response, but 2 (22%; 95% confidence interval, 0%-49%) achieved partial response and 3 had stable disease. Median progression-free and overall survival times were 2.1 and 9.5 months, respectively.
  
  
  CONCLUSIONS
  Docetaxel plus nedaplatin chemotherapy seems to be a safe and feasible second-line regimen for the treatment of esophageal SCC. We recommend the administration of 50 mg/m² docetaxel (day 1) plus 70 mg/m² nedaplatin (day 1) every 4 weeks in a phase II study.
authors: Departments of *Gastroenterology and Hematology, Faculty of Medicine †Department of Medical Oncology, University of Toyama, 2630 Sugitani, Toyama-shi, Toyama-ken 930-0194, Japan.
authors: Shinya
authors: S
authors: Kajiura
authors: Ayumu
authors: A
authors: Hosokawa
authors: Hiroki
authors: H
authors: Yoshita
authors: Yuko
authors: Y
authors: Ueda
authors: Akira
authors: A
authors: Ueda
authors: Hiroshi
authors: H
authors: Mihara
authors: Takayuki
authors: T
authors: Ando
authors: Haruka
authors: H
authors: Fujinami
authors: Jun
authors: J
authors: Nishikawa
authors: Kohei
authors: K
authors: Ogawa
authors: Masami
authors: M
authors: Minemura
authors: Toshiro
authors: T
authors: Sugiyama
mesh_terms: D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001859:Bone Neoplasms / Q000188:drug therapy* / Q000556:secondary; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000473:pathology / Q000556:secondary; D002945:Cisplatin / Q000008:administration & dosage; D018572:Disease-Free Survival; D000077143:Docetaxel; D004305:Dose-Response Relationship, Drug; D004938:Esophageal Neoplasms / Q000188:drug therapy* / Q000473:pathology; D000077277:Esophageal Squamous Cell Carcinoma; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D007970:Leukopenia / Q000139:chemically induced; D008113:Liver Neoplasms / Q000188:drug therapy* / Q000556:secondary; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000556:secondary; D008198:Lymph Nodes / Q000473:pathology*; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced; D009362:Neoplasm Metastasis; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy* / Q000473:pathology; D009503:Neutropenia / Q000139:chemically induced; D009944:Organoplatinum Compounds / Q000008:administration & dosage; D043823:Taxoids / Q000008:administration & dosage; D017211:Treatment Failure; D014839:Vomiting / Q000139:chemically induced
chemical_list: D009944:Organoplatinum Compounds; D043823:Taxoids; D000077143:Docetaxel; C053989:nedaplatin; D002945:Cisplatin; D005472:Fluorouracil