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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).

AbstractOBJECTIVE:
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.
AuthorsYutaka Ueda, Takashi Miyatake, Masaaki Nagamatsu, Masato Yamasaki, Yukihiro Nishio, Kiyoshi Yoshino, Masami Fujita, Tateki Tsutsui, Takayuki Enomoto, Tadashi Kimura
JournalEuropean journal of obstetrics, gynecology, and reproductive biology (Eur J Obstet Gynecol Reprod Biol) Vol. 170 Issue 1 Pg. 259-63 (Sep 2013) ISSN: 1872-7654 [Electronic] Ireland
PMID23880598 (Publication Type: Clinical Trial, Phase II, Journal Article)
CopyrightCopyright © 2013 Elsevier Ireland Ltd. All rights reserved.
Chemical References
  • Antineoplastic Agents
  • Taxoids
  • docetaxel
  • irinotecan
  • Carboplatin
  • Paclitaxel
  • Camptothecin
Topics
  • Adenocarcinoma, Clear Cell (drug therapy, mortality)
  • Adenocarcinoma, Mucinous (drug therapy, mortality)
  • Adult
  • Aged
  • Antineoplastic Agents (administration & dosage, adverse effects)
  • Antineoplastic Combined Chemotherapy Protocols
  • Camptothecin (administration & dosage, adverse effects, analogs & derivatives)
  • Carboplatin
  • Disease-Free Survival
  • Drug Resistance, Neoplasm
  • Female
  • Humans
  • Japan (epidemiology)
  • Middle Aged
  • Ovarian Neoplasms (drug therapy, mortality)
  • Paclitaxel
  • Prospective Studies
  • Taxoids (administration & dosage, adverse effects)

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