A randomized phase II evaluation of bryostatin-1 (NSC #339555) in recurrent or persistent platinum-sensitive ovarian cancer: A Gynecologic Oncology Group Study

Deborah K. Armstrong, John A. Blessing, Katherine Y. Look, Russell Schilder, Evelyn R. Nunez

Research output: Contribution to journalArticlepeer-review

Abstract

Objectives. The Gynecologic Oncology Group (GOG) performed a randomized phase II study to determine the antitumor activity and toxicity of two different schedules of bryostatin-1 administration in patients with recurrent or persistent platinum-sensitive epithelial ovarian cancer or primary peritoneal carcinoma. Methods. Eligible patients were randomized to receive either bryostatin-1 25 μg/m2 as a 1 h infusion weekly for 3 weeks followed by a 1-week rest (Regimen I) or bryostatin-1 120 μg/m2 as a 72 h continuous infusion every 2 weeks (Regimen II). Results. Fifty-five patients were enrolled on this study. There was one durable response among 27 eligible patients (response rate = 3.7%) on Regimen II and no responses in the 27 eligible patients on Regimen I. Nineteen patients (eleven on Regimen I and eight on Regimen II) had stable disease. The most common adverse event was myalgia, with 12 of 27 patients (44%) on each regimen experiencing some degree of myalgia. There were no other significant toxicities on either treatment arm. Conclusions. Both of these schedules and doses of bryostatin-1 are inactive as single agents in previously treated epithelial ovarian cancer.

Original languageEnglish (US)
Pages (from-to)373-377
Number of pages5
JournalInvestigational New Drugs
Volume21
Issue number3
DOIs
StatePublished - Aug 2003

Keywords

  • Bryostatin-1
  • Ovarian cancer
  • Platinum-sensitive
  • Protein kinase C (PKC)

ASJC Scopus subject areas

  • Oncology
  • Pharmacology
  • Pharmacology (medical)

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