Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006942
Status:
COMPLETED
Last Update Posted:
2013-08-26
First Post:
2000-12-06
Brief Title:
Bryostatin 1 and Cisplatin in Treating Patients With Advanced Recurrent or Residual Ovarian Epithelial Fallopian Tube or Primary Peritoneal Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Trial of Bryostatin in Combination With Cisplatin in Patients With Recurrent or Persistent Epithelial Ovarian Cancer
Status:
COMPLETED
Status Verified Date:
2013-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Phase II trial to study the effectiveness of combining bryostatin 1 and cisplatin in treating patients who have advanced recurrent or residual ovarian epithelial fallopian tube or primary peritoneal cancer Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining more than one drug may kill more tumor cells
Detailed Description:
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 WAF1CIP1 gene expression prior to and directly after chemotherapy bcl-2 gene expression in vivo bcl-2bax 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
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 WAF1CIP1 gene expression prior to and directly after chemotherapy bcl-2 gene expression in vivo bcl-2bax 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| N01CM17101 | NIH | CTEP | httpsreporternihgovquickSearchN01CM17101 |
| NCI-2012-02831 | REGISTRY | None | None |
| PHII-21 | OTHER | None | None |
| T99-0039 | OTHER | None | None |