Phase I study of combination chemotherapy with irinotecan hydrochloride and nedaplatin for cervical squamous cell carcinoma: Japanese gynecologic oncology group study

Oncol Rep. 2009 Apr;21(4):1005-9. doi: 10.3892/or_00000316.


The aim of this study (JGOG1063) was to determine the recommended dose (RD) for combination chemotherapy with irinotecan hydrochloride (CPT-11) and nedaplatin (NDP) for advanced cervical squamous cell carcinoma. CPT-11 was given intravenously in fixed doses of 60 mg/m2 on days 1 and 8 and NDP, in escalating doses, on day 1, every 4 weeks. A total of 15 patients were enrolled in the study. At level 1 (NDP: 50 mg/m2), one of the 3 patients developed grade 3 diarrhea, so 3 additional patients were enrolled at this level. As none of the 3 additional patients exhibited dose-limiting toxicity, level 1 was elevated to level 2 (NDP: 60 mg/m2). The maximum tolerated dose was not reached, even at the highest dose level (level 4; NDP: 80 mg/m2). No further dose escalation was carried out, and level 4 (CPT-11: 60 mg/m2, NDP: 80 mg/m2) was determined as the RD.

Publication types

  • Clinical Trial, Phase I

MeSH terms

  • Adult
  • Aged
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Camptothecin / administration & dosage
  • Camptothecin / adverse effects
  • Camptothecin / analogs & derivatives
  • Carcinoma, Squamous Cell / drug therapy*
  • Female
  • Humans
  • Irinotecan
  • Middle Aged
  • Organoplatinum Compounds / administration & dosage
  • Organoplatinum Compounds / adverse effects
  • Uterine Cervical Neoplasms / drug therapy*


  • Organoplatinum Compounds
  • Irinotecan
  • nedaplatin
  • Camptothecin