Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00132067
Status:
COMPLETED
Last Update Posted:
2019-07-23
First Post:
2005-08-16
Brief Title:
Vorinostat in Treating Patients With Recurrent or Persistent Ovarian Epithelial or Primary Peritoneal Cavity Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Evaluation of Vorinostat SAHA NCI-Supplied Agent NSC 701852 in the Treatment of Persistent or Recurrent Epithelial Ovarian or Primary Peritoneal Carcinoma
Status:
COMPLETED
Status Verified Date:
2019-07
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:
This phase II trial is studying how well vorinostat works in treating patients with recurrent or persistent ovarian epithelial or primary peritoneal cavity cancer Drugs used in chemotherapy such as vorinostat work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Vorinostat may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth
Detailed Description:
PRIMARY OBJECTIVES
I Determine the 6-month progression-free survival rate in patients with recurrent or persistent ovarian epithelial or primary peritoneal cavity cancer treated with vorinostat
II Determine the toxicity of this drug in terms of the frequency and severity of adverse reactions in these patients
SECONDARY OBJECTIVES
I Determine the clinical response rate partial response and complete response in patients treated with this drug
II Determine the duration of progression-free survival and overall survival of patients treated with this drug
III Determine the impact of prognostic variables eg platinum sensitivity performance status and cellular histology in patients treated with this drug
OUTLINE This is a nonrandomized multicenter study
Patients receive oral vorinostat twice daily on days 1-14 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed every 3 months for 2 years and then every 6 months for 3 years
PROJECTED ACCRUAL A total of 22-60 patients will be accrued for this study within approximately 1 year
I Determine the 6-month progression-free survival rate in patients with recurrent or persistent ovarian epithelial or primary peritoneal cavity cancer treated with vorinostat
II Determine the toxicity of this drug in terms of the frequency and severity of adverse reactions in these patients
SECONDARY OBJECTIVES
I Determine the clinical response rate partial response and complete response in patients treated with this drug
II Determine the duration of progression-free survival and overall survival of patients treated with this drug
III Determine the impact of prognostic variables eg platinum sensitivity performance status and cellular histology in patients treated with this drug
OUTLINE This is a nonrandomized multicenter study
Patients receive oral vorinostat twice daily on days 1-14 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed every 3 months for 2 years and then every 6 months for 3 years
PROJECTED ACCRUAL A total of 22-60 patients will be accrued for this study within approximately 1 year
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 |
|---|---|---|---|
| U10CA027469 | NIH | CTEP | httpsreporternihgovquickSearchU10CA027469 |
| NCI-2012-02667 | REGISTRY | None | None |
| GOG 0170H | None | None | None |
| CDR0000439489 | None | None | None |
| GOG-0170H | OTHER | None | None |
| GOG-0170H | OTHER | None | None |