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 Kay Armstrong, John A. Blessing, Janet Rader, Joel I. Sorosky

Research output: Contribution to journalArticle

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.

Original languageEnglish (US)
Pages (from-to)453-457
Number of pages5
JournalInvestigational New Drugs
Volume21
Issue number4
DOIs
StatePublished - Nov 2003

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Cervix Uteri
Squamous Cell Carcinoma
Myalgia
Appointments and Schedules
bryostatin 1
Therapeutics
Drug Therapy

Keywords

  • Advanced cervical cancer
  • Bryostatin-1
  • Protein kinase C (PKC)

ASJC Scopus subject areas

  • Molecular Medicine
  • Pharmacology

Cite this

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. / Armstrong, Deborah Kay; Blessing, John A.; Rader, Janet; Sorosky, Joel I.

In: Investigational New Drugs, Vol. 21, No. 4, 11.2003, p. 453-457.

Research output: Contribution to journalArticle

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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.",
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