A Phase II Trial of Bryostatin in Combination With Cisplatin in Patients With Recurrent or Persistent Epithelial Ovarian Cancer
PRIMARY OBJECTIVES:
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.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall survival
Time from first day of treatment to time of death due to any cause, assessed up to 9 years
No
Robert Morgan
Principal Investigator
Beckman Research Institute
United States: Food and Drug Administration
NCI-2012-02831
NCT00006942
October 2000
Name | Location |
---|---|
City of Hope | Duarte, California 91010 |