Ignite Creation Date:
2024-05-05 @ 5:27 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00459290
Status:
COMPLETED
Last Update Posted:
2018-07-18
First Post:
2007-04-09
Brief Title:
Mifepristone in Treating Patients With Recurrent or Persistent Ovarian Epithelial Primary Peritoneal or Fallopian Tube Cancer
Sponsor:
Gynecologic Oncology Group
Organization:
GOG Foundation
Study Overview
Official Title:
A Phase II Evaluation of Mifepristone in the Treatment of Recurrent or Persistent Epithelial Ovarian or Primary Peritoneal Carcinoma
Status:
COMPLETED
Status Verified Date:
2014-06
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 Progesterone can cause the growth of ovarian epithelial cancer primary peritoneal cancer or fallopian tube cancer Hormone therapy using mifepristone may fight ovarian epithelial cancer and primary peritoneal cancer by lowering the amount of progesterone the body makes
PURPOSE This phase II trial is studying the side effects and how well mifepristone works in treating patients with recurrent or persistent ovarian epithelial cancer primary peritoneal cancer or fallopian tube cancer
PURPOSE This phase II trial is studying the side effects and how well mifepristone works in treating patients with recurrent or persistent ovarian epithelial cancer primary peritoneal cancer or fallopian tube cancer
Detailed Description:
OBJECTIVES
Primary
Determine the antitumor activity of mifepristone in patients with recurrent or persistent ovarian epithelial primary peritoneal or fallopian tube carcinoma
Determine the toxicity of this drug in these patients
Secondary
Determine the duration of progression-free survival and overall survival of patients treated with this drug
Determine the potential impact of platinum sensitivity initial performance status and age on prognosis in these patients
OUTLINE This is a multicenter study
Patients receive oral mifepristone once daily on days 1-28 Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity
After completion of study therapy patients are followed periodically for 5 years
PROJECTED ACCRUAL A total of 52 patients will be accrued for this study
Primary
Determine the antitumor activity of mifepristone in patients with recurrent or persistent ovarian epithelial primary peritoneal or fallopian tube carcinoma
Determine the toxicity of this drug in these patients
Secondary
Determine the duration of progression-free survival and overall survival of patients treated with this drug
Determine the potential impact of platinum sensitivity initial performance status and age on prognosis in these patients
OUTLINE This is a multicenter study
Patients receive oral mifepristone once daily on days 1-28 Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity
After completion of study therapy patients are followed periodically for 5 years
PROJECTED ACCRUAL A total of 52 patients will be accrued for this study
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