Ignite Creation Date:
2025-12-17 @ 2:44 PM
Ignite Modification Date:
2025-12-23 @ 4:53 PM
Study NCT ID:
NCT00091195
Status:
TERMINATED
Last Update Posted:
2013-03-19
First Post:
2004-09-07
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Depsipeptide (Romidepsin) in Treating Patients With Recurrent Ovarian Epithelial or Peritoneal Cavity Cancer
Sponsor:
National Cancer Institute (NCI)
Organization:
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| CCCWFU 83403 | None | None | View | |
| U10CA081851 | NIH | None | https://reporter.nih.gov/quic… | View |