Investigational New Drugs

, Volume 21, Issue 4, pp 453–457 | Cite as

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

  • Deborah K. Armstrong
  • John A. Blessing
  • Janet Rader
  • Joel I. Sorosky
Article

Abstract

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 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: 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.

bryostatin-1 advanced cervical cancer protein kinase C (PKC) 

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Copyright information

© Kluwer Academic Publishers 2003

Authors and Affiliations

  • Deborah K. Armstrong
    • 1
  • John A. Blessing
    • 2
  • Janet Rader
    • 3
  • Joel I. Sorosky
    • 4
  1. 1.Oncology, Gynecology, and ObstetricsJohns Hopkins Oncology CenterBaltimore
  2. 2.Gynecologic Oncology Group Statistical and Data CenterRoswell Park Cancer InstituteBuffalo
  3. 3.Department of Obstetrics and Gynecology, Division of Gynecologic OncologyWashington University School of MedicineSt. Louis
  4. 4.Division of Gynecologic OncologyUniversity of Iowa Hospitals and ClinicsIowa City

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