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)

Eur J Obstet Gynecol Reprod Biol. 2013 Sep;170(1):259-63. doi: 10.1016/j.ejogrb.2013.06.035. Epub 2013 Jul 20.

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.

Study design: 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.

Conclusion: 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.

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.

Publication types

  • Clinical Trial, Phase II

MeSH terms

  • Adenocarcinoma, Clear Cell / drug therapy*
  • Adenocarcinoma, Clear Cell / mortality
  • Adenocarcinoma, Mucinous / drug therapy*
  • Adenocarcinoma, Mucinous / mortality
  • Adult
  • Aged
  • Antineoplastic Agents / administration & dosage
  • Antineoplastic Agents / adverse effects
  • Antineoplastic Combined Chemotherapy Protocols*
  • Camptothecin / administration & dosage
  • Camptothecin / adverse effects
  • Camptothecin / analogs & derivatives
  • Carboplatin
  • Disease-Free Survival
  • Docetaxel
  • Drug Resistance, Neoplasm*
  • Female
  • Humans
  • Irinotecan
  • Japan / epidemiology
  • Middle Aged
  • Ovarian Neoplasms / drug therapy*
  • Ovarian Neoplasms / mortality
  • Paclitaxel
  • Prospective Studies
  • Taxoids / administration & dosage
  • Taxoids / adverse effects

Substances

  • Antineoplastic Agents
  • Taxoids
  • Docetaxel
  • Irinotecan
  • Carboplatin
  • Paclitaxel
  • Camptothecin