title: A phase II study of combination chemotherapy using docetaxel and irinotecan for TC-refractory or TC-resistant ovarian carcinomas (GOGO-OV2 study) and for primary clear or mucinous ovarian carcinomas (GOGO-OV3 Study).
abstract: OBJECTIVE
  To analyze the efficacy and safety of combination chemotherapy of docetaxel and irinotecan for paclitaxel and carboplatin (TC) -refractory or -resistant ovarian carcinomas and for first treatment of primary clear cell and mucinous ovarian carcinomas.
  
  
  METHODS
  Between 2002 and 2009, we conducted a prospective Phase II study of the efficacy and safety of combination chemotherapy using docetaxel and irinotecan in 62 patients with TC-refractory or -resistant ovarian carcinoma cases (GOGO-OV2) and 15 patients with primary clear cell and mucinous ovarian carcinoma cases (GOGO-OV3). The dose of docetaxel and irinotecan was determined during our previous Phase I study.
  
  
  RESULTS
  A docetaxel plus irinotecan regimen provided a 53% response rate, 6 months progression-free survival (PFS), and 12 months overall survival (OS) for primary clear cell and mucinous ovarian carcinomas (similar to TC therapy). The differences of anti-tumor and survival effects between refractory and resistant cases were not statistically significant. The regimen also provided a 15% response rate, 5 months PFS, and 15 months OS for TC-refractory or TC-resistant cases, when used as a second-line chemotherapy. These data are similar to previous reports, however, our study provides the first data exclusively for the cases refractory or resistant to a gold standard TC therapy as a second-line chemotherapy. The regimen was demonstrated to be well tolerable.
  
  
  CONCLUSIONS
  Combination chemotherapy of docetaxel and irinotecan may be a useful option to treat TC-refractory/resistant cases and primary clear cell and mucinous adenocarcinoma cases of ovarian carcinoma.
authors.affiliation: Department of Obstetrics and Gynecology, Osaka University Graduate School of Medicine, 2-2, Yamadaoka, Suita, Osaka 565-0871, Japan. Electronic address: ZVF03563@nifty.ne.jp.
authors.forename: Yutaka
authors.initials: Y
authors.lastname: Ueda
authors.forename: Takashi
authors.initials: T
authors.lastname: Miyatake
authors.forename: Masaaki
authors.initials: M
authors.lastname: Nagamatsu
authors.forename: Masato
authors.initials: M
authors.lastname: Yamasaki
authors.forename: Yukihiro
authors.initials: Y
authors.lastname: Nishio
authors.forename: Kiyoshi
authors.initials: K
authors.lastname: Yoshino
authors.forename: Masami
authors.initials: M
authors.lastname: Fujita
authors.forename: Tateki
authors.initials: T
authors.lastname: Tsutsui
authors.forename: Takayuki
authors.initials: T
authors.lastname: Enomoto
authors.forename: Tadashi
authors.initials: T
authors.lastname: Kimura
mesh_terms: D018262:Adenocarcinoma, Clear Cell / Q000188:drug therapy* / Q000401:mortality; D002288:Adenocarcinoma, Mucinous / Q000188:drug therapy* / Q000401:mortality; D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols; D002166:Camptothecin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D016190:Carboplatin; D018572:Disease-Free Survival; D000077143:Docetaxel; D019008:Drug Resistance, Neoplasm; D005260:Female; D006801:Humans; D000077146:Irinotecan; D007564:Japan / Q000453:epidemiology; D008875:Middle Aged; D010051:Ovarian Neoplasms / Q000188:drug therapy* / Q000401:mortality; D017239:Paclitaxel; D011446:Prospective Studies; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects
chemical_list: D000970:Antineoplastic Agents; D043823:Taxoids; D000077143:Docetaxel; D000077146:Irinotecan; D016190:Carboplatin; D017239:Paclitaxel; D002166:Camptothecin
keywords: CR; Clear cell; Docetaxel; Irinotecan; MDCT; Mucinous; OS; Ovarian cancer; PD; PFS; PR; RR; Refractory; Resistant; SD; TC; TFI; complete response; multi-detector row computed tomography; overall survival; paclitaxel and carboplatin; partial response; progression-free survival; progressive disease; responsive rate; stable disease; treatment-free interval