A randomized Phase II/III trial of 3 weekly intraperitoneal versus intravenous carboplatin in combination with intravenous weekly dose-dense paclitaxel for newly diagnosed ovarian, fallopian tube and primary peritoneal cancer

Jpn J Clin Oncol. 2011 Feb;41(2):278-82. doi: 10.1093/jjco/hyq182. Epub 2010 Oct 11.

Abstract

Retrospective studies and a Phase II trial demonstrated the promising efficacy and safety of intraperitoneal administration of carboplatin in ovarian, fallopian tube and primary peritoneal cancer. A Japanese Gynecologic Oncology Group 3016 randomized Phase III trial for these cancers showed dose-dense weekly administration of paclitaxel significant improvement of progression-free survival and overall survival over every 3-week administration. From June 2010, we have been conducting a randomized Phase II/III trial of intravenous versus intraperitoneal administration of carboplatin every 3 week in combination with dose-dense weekly administration of paclitaxel. The purpose of this trial is to prove the superiority of intraperitoneal administration of carboplatin over intravenous administration. Primary endpoint is progression-free survival and secondary endpoints include overall survival, quality of life assessment and cost-benefit. The first 120 patients will be evaluated for the feasibility of intraperitoneal arm and a total of 746 patients will be enrolled in a Phase III study.

Publication types

  • Comparative Study
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Carboplatin / administration & dosage
  • Clinical Trials, Phase II as Topic*
  • Clinical Trials, Phase III as Topic*
  • Fallopian Tube Neoplasms / drug therapy*
  • Fallopian Tube Neoplasms / pathology
  • Female
  • Humans
  • Infusions, Intravenous
  • Infusions, Parenteral
  • Japan
  • Ovarian Neoplasms / drug therapy*
  • Ovarian Neoplasms / pathology
  • Paclitaxel / administration & dosage
  • Patient Selection
  • Peritoneal Neoplasms / drug therapy*
  • Peritoneal Neoplasms / pathology
  • Randomized Controlled Trials as Topic*
  • Research Design

Substances

  • Carboplatin
  • Paclitaxel