title: Phase I study of combination chemotherapy with irinotecan hydrochloride and nedaplatin for cervical squamous cell carcinoma: Japanese gynecologic oncology group study.
abstract: 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.
authors.affiliation: Department of Obstetrics and Gynecology, Sakai Hospital, Kinki University School of Medicine, Osaka 590-0132, Japan. yamamoto@sakai.med.kindai.ac.jp
authors.forename: Kaichiro
authors.initials: K
authors.lastname: Yamamoto
authors.forename: Katsuji
authors.initials: K
authors.lastname: Kokawa
authors.forename: Naohiko
authors.initials: N
authors.lastname: Umesaki
authors.forename: Ryuichiro
authors.initials: R
authors.lastname: Nishimura
authors.forename: Kazuo
authors.initials: K
authors.lastname: Hasegawa
authors.forename: Ikuo
authors.initials: I
authors.lastname: Konishi
authors.forename: Fumitaka
authors.initials: F
authors.lastname: Saji
authors.forename: Masato
authors.initials: M
authors.lastname: Nishida
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Noguchi
authors.forename: Ken
authors.initials: K
authors.lastname: Takizawa
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002166:Camptothecin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy*; D005260:Female; D006801:Humans; D000077146:Irinotecan; D008875:Middle Aged; D009944:Organoplatinum Compounds / Q000008:administration & dosage / Q000009:adverse effects; D002583:Uterine Cervical Neoplasms / Q000188:drug therapy*
chemical_list: D009944:Organoplatinum Compounds; D000077146:Irinotecan; C053989:nedaplatin; D002166:Camptothecin