Ignite Creation Date:
2024-05-05 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00085527
Status:
WITHDRAWN
Last Update Posted:
2013-09-05
First Post:
2004-06-10
Brief Title:
FR901228 in Treating Patients With Relapsed or Refractory Advanced Ovarian Epithelial Cancer
Sponsor:
University of Chicago
Organization:
University of Chicago
Study Overview
Official Title:
A Phase II Study Of Depsipeptide In Patients With Relapsed Or Refractory Ovarian Carcinoma
Status:
WITHDRAWN
Status Verified Date:
2013-09
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 FR901228 may stop the growth of tumor cells by blocking the enzymes necessary for their growth
PURPOSE This phase II trial is studying how well FR901228 works in treating patients with relapsed or refractory advanced ovarian epithelial cancer
PURPOSE This phase II trial is studying how well FR901228 works in treating patients with relapsed or refractory advanced ovarian epithelial cancer
Detailed Description:
OBJECTIVES
Primary
Determine the response rate complete and partial in patients with relapsed or refractory advanced ovarian epithelial carcinoma treated with FR901228 depsipeptide
Determine the toxicity of this drug in these patients
Secondary
Correlate clinical response with platinum sensitivity in patients treated with this drug
Correlate clinical response with P-glycoprotein expression or p53 status in patients treated with this drug
OUTLINE This is multicenter study Patients are stratified according to response to prior platinum administration platinum resistant vs platinum sensitive
Patients receive FR901228 depsipeptide IV over 4 hours on days 1 8 and 15 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 20-37 patients will be accrued for this study within 12 months
Primary
Determine the response rate complete and partial in patients with relapsed or refractory advanced ovarian epithelial carcinoma treated with FR901228 depsipeptide
Determine the toxicity of this drug in these patients
Secondary
Correlate clinical response with platinum sensitivity in patients treated with this drug
Correlate clinical response with P-glycoprotein expression or p53 status in patients treated with this drug
OUTLINE This is multicenter study Patients are stratified according to response to prior platinum administration platinum resistant vs platinum sensitive
Patients receive FR901228 depsipeptide IV over 4 hours on days 1 8 and 15 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 20-37 patients will be accrued for this study within 12 months
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-6347 | None | None | None |
| UCCRC-12965 | None | None | None |
| LUMC-106995 | None | None | None |