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.

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.

• Authors: Yutaka Ueda, Takashi Miyatake, Masaaki Nagamatsu, Masato Yamasaki, Yukihiro Nishio, Kiyoshi Yoshino, Masami Fujita, Tateki Tsutsui, Takayuki Enomoto, Tadashi Kimura
• Journal: European 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
• PMID: 23880598 (Publication Type: Clinical Trial, Phase II, Journal Article)
• Copyright: Copyright © 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
• Docetaxel
• Drug Resistance, Neoplasm
• Female
• Humans
• Irinotecan
• Japan (epidemiology)
• Middle Aged
• Ovarian Neoplasms (drug therapy, mortality)
• Paclitaxel
• Prospective Studies
• Taxoids (administration & dosage, adverse effects)