bryostatin-1 and Peritoneal-Neoplasms

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.. Eligible patients were randomized to receive either bryostatin-1 25 microg/m2 as a 1h infusion weekly for 3 weeks followed by a 1-week rest (Regimen I) or bryostatin-1 120 microg/m2 as a 72 h continuous infusion every 2 weeks (Regimen II).. 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.. Both of these schedules and doses of bryostatin-1 are inactive as single agents in previously treated epithelial ovarian cancer.

Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Agents; Bryostatins; Drug Administration Schedule; Female; Humans; Lactones; Macrolides; Middle Aged; Neoplasm Recurrence, Local; Neoplasms, Glandular and Epithelial; Ovarian Neoplasms; Peritoneal Neoplasms; Treatment Outcome