A randomized phase II evaluation of bryostatin-1 (NSC #339555) in persistent or recurrent squamous cell carcinoma of the cervix: A Gynecologic Oncology Group Study

Objectives: The Gynecologic Oncology Group performed a randomized phase II study to determine the antitumor activity and toxicity of two different schedules of administration of bryostatin-1 in patients with persistent or recurrent squamous cell carcinoma of the cervix. 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 II). Results: A total of 70 patients were enrolled on this study. There were 32 eligible patients on Regimen I and 33 eligible patients on Regimen II; all but 4 had had prior chemotherapy. There were two partial responses (one on each treatment arm) among the 65 eligible patients (response rates = 3.1 and 3.0%, respectively). Ten patients on each regimen had stable disease. The most common adverse event was myalgia; 8 of 32 patients (25%) on Regimen I and 16 of 33 patients (48%) on Regimen II had any grade of myalgia. There was no significant myelosuppression on either treatment arm. Conclusions: Both of these schedules and doses of bryostatin-1 are inactive as single agents in the second-line treatment of squamous cell carcinoma of the cervix.