Ignite Creation Date:
2024-05-05 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00091195
Status:
TERMINATED
Last Update Posted:
2013-03-19
First Post:
2004-09-07
Brief Title:
Depsipeptide Romidepsin in Treating Patients With Recurrent Ovarian Epithelial or Peritoneal Cavity Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study Of Single Agent Depsipeptide FK228 In Recurrent Platinum Sensitive Adeno-Carcinoma Of The Ovary Or Peritoneum
Status:
TERMINATED
Status Verified Date:
2013-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Administratively complete
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase II trial is studying how well depsipeptide romidepsin works in treating patients with recurrent ovarian epithelial or peritoneal cavity cancer Drugs used in chemotherapy such as depsipeptide romidepsin work in different ways to stop tumor cells from dividing so they stop growing or die Depsipeptide romidepsin may also stop the growth of ovarian epithelial or peritoneal cavity cancer by stopping blood flow to the tumor and by blocking the enzymes necessary for their growth
Detailed Description:
PRIMARY OBJECTIVES
I To estimate the response rate of recurrent platinum-sensitive adenocarcinoma of the ovarian or peritoneal to depsipeptide romidepsin
II To determine the toxicity of depsipeptide in this patient population
OUTLINE This is a multicenter study
Patients receive depsipeptide romidepsin intravenously IV over 4 hours on days 1 8 and 15 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Patients are followed up for 5 years
I To estimate the response rate of recurrent platinum-sensitive adenocarcinoma of the ovarian or peritoneal to depsipeptide romidepsin
II To determine the toxicity of depsipeptide in this patient population
OUTLINE This is a multicenter study
Patients receive depsipeptide romidepsin intravenously IV over 4 hours on days 1 8 and 15 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Patients are followed up for 5 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 |
|---|---|---|---|
| CCCWFU 83403 | None | None | None |
| U10CA081851 | NIH | None | httpsreporternihgovquickSearchU10CA081851 |