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


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.
Armstrong
Deborah K
DK
Sidney Kimmal Comprehensive Cancer Centèr John Hopkins, Baltimore, MD 21231, USA. darmstro@jhmi.edu
Blessing
John A
JA
Look
Katherine Y
KY
Schilder
Russell
R
Nunez
Evelyn R
ER
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D054713:Bryostatins; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007783:Lactones / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D018942:Macrolides; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local; D009375:Neoplasms, Glandular and Epithelial / Q000188:drug therapy*; D010051:Ovarian Neoplasms / Q000188:drug therapy*; D010534:Peritoneal Neoplasms / Q000188:drug therapy; D016896:Treatment Outcome
D000970:Antineoplastic Agents; D054713:Bryostatins; D007783:Lactones; D018942:Macrolides; C046785:bryostatin 1