A Phase II Trial of Bryostatin in Combination With Cisplatin in Patients With Recurrent or Persistent Epithelial Ovarian Cancer
I. To estimate the overall response rate and the complete response rate of patients with
platinum-refractory ovarian cancer who are treated with infusional Bryostatin-1 given in
combination with intravenous cisplatin.
II. To estimate the duration of response in these patients. III. To obtain tissue in order
to evaluate the molecular determinants of apoptosis including: p53 status, WAF1/CIP1 gene
expression prior to and directly after chemotherapy, bcl-2 gene expression in vivo,
bcl-2/bax ratio, p21, and the extent of apoptosis determined by the TdT assay; and the
molecular determinants of DNA damage and repair including: expression levels of ERCC1.
OUTLINE: This is a multicenter study.
Patients receive bryostatin 1 IV continuously over 72 hours immediately followed by
cisplatin IV over 1 hour. Treatment continues every 3 weeks for a minimum of 2 courses in
the absence of disease progression.
Patients are followed for survival.
PROJECTED ACCRUAL: A total of 18-32 patients will be accrued for this study within 2 years.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Time from first day of treatment to time of death due to any cause, assessed up to 9 years
Beckman Research Institute
United States: Food and Drug Administration
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