Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00017134
Status:
TERMINATED
Last Update Posted:
2013-06-10
First Post:
2001-06-06
Brief Title:
Fenretinide Followed by Surgery Compared With Surgery Alone in Preventing Ovarian Cancer in Patients at Increased Risk
Sponsor:
Gynecologic Oncology Group
Organization:
GOG Foundation
Study Overview
Official Title:
An Exploratory Evaluation of Fenretinide 4-HPR as a Chemopreventive Agent for Ovarian Carcinoma
Status:
TERMINATED
Status Verified Date:
2006-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Withdrawn due to poor accrual
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer It is not yet known whether fenretinide given before surgery is more effective in preventing ovarian cancer than surgery alone
PURPOSE Randomized clinical trial to compare the effectiveness of fenretinide followed by surgery with that of surgery alone in preventing ovarian cancer in patients who are at increased risk
PURPOSE Randomized clinical trial to compare the effectiveness of fenretinide followed by surgery with that of surgery alone in preventing ovarian cancer in patients who are at increased risk
Detailed Description:
OBJECTIVES
Compare the frequency of histopathology markers or precursor lesions of the ovaries including surface papillomatosis invaginations pseudostratification and inclusion cysts removed from patients at increased risk for ovarian cancer between those receiving fenretinide vs those undergoing immediate oophorectomy
Determine the relative abundance of markers of cell proliferation and apoptosis in cancer-prone ovaries of patients treated with fenretinide
OUTLINE This is a randomized multicenter study Patients are randomized to 1 of 2 arms
Arm I Patients undergo prophylactic oophorectomy
Arm II Patients receive oral fenretinide once daily for 27 days every 30 days for 6-8 weeks Treatment continues in the absence of unacceptable toxicity or diagnosis of malignancy After completion of fenretinide patients undergo prophylactic oophorectomy
Patients are followed every 3 months for 2 years and then every 6 months for 3 years
PROJECTED ACCRUAL A total of 71 patients will be accrued for this study within 2 years
Compare the frequency of histopathology markers or precursor lesions of the ovaries including surface papillomatosis invaginations pseudostratification and inclusion cysts removed from patients at increased risk for ovarian cancer between those receiving fenretinide vs those undergoing immediate oophorectomy
Determine the relative abundance of markers of cell proliferation and apoptosis in cancer-prone ovaries of patients treated with fenretinide
OUTLINE This is a randomized multicenter study Patients are randomized to 1 of 2 arms
Arm I Patients undergo prophylactic oophorectomy
Arm II Patients receive oral fenretinide once daily for 27 days every 30 days for 6-8 weeks Treatment continues in the absence of unacceptable toxicity or diagnosis of malignancy After completion of fenretinide patients undergo prophylactic oophorectomy
Patients are followed every 3 months for 2 years and then every 6 months for 3 years
PROJECTED ACCRUAL A total of 71 patients will be accrued for this study within 2 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 |
|---|---|---|---|
| GOG-0190 | None | None | None |