A phase II evaluation of belinostat and carboplatin in the treatment of recurrent or persistent platinum-resistant ovarian, fallopian tube, or primary peritoneal carcinoma: A gynecologic oncology group study

Don S. Dizon, John A. Blessing, Richard T. Penson, Richard D. Drake, Joan L. Walker, Carolyn M. Johnston, Paul A. Disilvestro, Amanda Nickles Fader

Research output: Contribution to journalArticle

Abstract

Background: Patients with recurrent ovarian cancer have limited options, especially in the context of relapse less than six months from primary platinum-based therapy. This Gynecologic Oncology Group (GOG) study was conducted to evaluate the impact of the histone deacetylase inhibitor, belinostat, in combination with carboplatin in women with platinum-resistant ovarian cancer. Methods: Eligible patients had measurable, recurrent disease within six months of their last dose of a platinum-based combination. Belinostat was dosed at 1000 mg/m 2 daily for five days with carboplatin AUC 5 on day three of 21-day cycles. The primary endpoint was overall response rate (ORR), using a two-stage design. Results: Twenty-nine women enrolled on study and 27 were evaluable. The median number of cycles given was two (range 1-10). One patient had a complete response and one had a partial response, for an ORR of 7.4% (95% CI, .9%-24.3%). Twelve patients had stable disease while eight had increasing disease. Response could not be assessed in five (18.5%). Grade 3 and 4 events occurring in more than 10% of treated patients were uncommon and limited to neutropenia (22.2%), thrombocytopenia (14.8%), and vomiting (11.1%). The median progression-free survival (PFS) was 3.3 months and overall survival was 13.7 months. PFS of at least six months was noted in 29.6% of patients. Due to the lack of drug activity, the study was closed after the first-stage. Conclusions: The addition of belinostat to carboplatin had little activity in a population with platinum-resistant ovarian cancer.

Original languageEnglish (US)
Pages (from-to)367-371
Number of pages5
JournalGynecologic oncology
Volume125
Issue number2
DOIs
StatePublished - May 1 2012

Keywords

  • Carboplatin
  • Chemotherapy
  • HIDAC inhibitors
  • Ovarian cancer
  • Platinum-resistant

ASJC Scopus subject areas

  • Oncology
  • Obstetrics and Gynecology

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