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Armstrong DK , Blessing JA , Look KY , Schilder R , Nunez ER
A randomized phase II evaluation of bryostatin-1 (NSC #339555) in recurrent or persistent platinum-sensitive ovarian cancer: A Gynecologic Oncology Group Study
Investigational New Drugs. 2003 Aug;21(3) :373-377
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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 mug/m(2) as a 1 h infusion weekly for 3 weeks followed by a 1-week rest (Regimen 1) or bryostatin-1 120 mug/m(2) as a 72 h continuous infusion every 2 weeks (Regimen 11). 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.
Notes
Armstrong, DK,Johns Hopkins Oncol Ctr, Dept Obstet & Gynecol, Clin Res Bldg,Room 190,1650 Orleans St, Baltimore, MD 21231 USA Article English