Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005965
Status:
COMPLETED
Last Update Posted:
2013-07-10
First Post:
2000-07-05
Brief Title:
Bryostatin-1 Plus Cisplatin in Treating Patients With Recurrent or Advanced Cancer of the Cervix
Sponsor:
Icahn School of Medicine at Mount Sinai
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Clinical Trial of Bryostatin-1 NSC 339555 and Cisplatin in Patients With Recurrent andor Advanced Inoperable Squamous Cell Adeno or Adenosquamous Cell Carcinoma of the Cervix
Status:
COMPLETED
Status Verified Date:
2004-07
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:
RATIONALE 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
PURPOSE Phase II trial to study the effectiveness of bryostatin-1 plus cisplatin in treating patients who have recurrent or advanced cancer of the cervix
PURPOSE Phase II trial to study the effectiveness of bryostatin-1 plus cisplatin in treating patients who have recurrent or advanced cancer of the cervix
Detailed Description:
OBJECTIVES I Determine the safety and efficacy of bryostatin-1 plus cisplatin in patients with recurrent or advanced carcinoma of the cervix II Determine the response rate progression free interval and duration of survival of these patients when treated with this regimen
OUTLINE This is a multicenter study Patients receive bryostatin-1 IV over 1 hour and cisplatin IV over 1 hour on day 1 Treatment continues every 21 days in the absence of disease progression or unacceptable toxicity Patients are followed until death
PROJECTED ACCRUAL A total of 37 patients will be accrued for this study over 2-3 years
OUTLINE This is a multicenter study Patients receive bryostatin-1 IV over 1 hour and cisplatin IV over 1 hour on day 1 Treatment continues every 21 days in the absence of disease progression or unacceptable toxicity Patients are followed until death
PROJECTED ACCRUAL A total of 37 patients will be accrued for this study over 2-3 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 |
|---|---|---|---|
| NCI-T99-0082 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000067948 | REGISTRY | None | None |