Ignite Creation Date:
2024-05-05 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00098800
Status:
COMPLETED
Last Update Posted:
2010-03-24
First Post:
2004-12-08
Brief Title:
Fenretinide in Preventing Ovarian Cancer in Participants Who Are at High Risk for Developing Ovarian Cancer and Planning to Undergo Surgery to Remove the Ovaries
Sponsor:
University of Arizona
Organization:
University of Arizona
Study Overview
Official Title:
A Multicenter Randomized Double-Blinded Trial for Chemoprevention of Ovarian Cancer Modulation of Biomarkers and Spectral Properties Using Contrast Enhanced Ultrasound in High-Risk Women Using Fenretinide 4-HPR
Status:
COMPLETED
Status Verified Date:
2006-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Chemoprevention is the use of certain drugs to keep cancer from forming growing or coming back The use of fenretinide may prevent ovarian cancer
PURPOSE This randomized clinical trial is studying how well fenretinide works in preventing ovarian cancer in participants who are at high risk of developing ovarian cancer and planning to undergo surgery to remove the ovaries
PURPOSE This randomized clinical trial is studying how well fenretinide works in preventing ovarian cancer in participants who are at high risk of developing ovarian cancer and planning to undergo surgery to remove the ovaries
Detailed Description:
OBJECTIVES
Primary
Compare the induction of apoptosis as determined by TUNEL in the ovarian epithelial and stromal cells of participants at high risk for ovarian cancer treated with fenretinide vs placebo
Secondary
Compare modulation of several intermediate markers TGFβ BAX Ki-67 ER PR RARβ TGFβRI TGFβRII p21 p53 FAS and FASL in participants treated with these regimens
Compare early microvascular changes using contrast-enhanced ultrasound in participants treated with these drugs
Determine whether the use of contrast agents could indicate changes in ovarian size and architecture that may be assessed as potential surrogates for preventive effect in these participants
Determine the feasibility of future chemoprevention trials for ovarian cancer
Determine the toxicity of fenretinide in these participants
Compare the microvascularity index and ovarian volume of participants treated with these drugs
Correlate areas of increased microvascularity and other abnormalities with pathology findings obtained at oophorectomy in participants treated with these drugs
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Participants are randomized to 1 of 2 treatment arms
Arm I Participants receive oral fenretinide once daily
Arm II Participants receive oral placebo once daily In both arms treatment continues for 6-8 weeks in the absence of unacceptable toxicity
Within 5 days after completion of fenretinide or placebo participants undergo bilateral salpingo-oophorectomy
Participants are followed at 6 weeks
PROJECTED ACCRUAL A total of 40 participants 20 per treatment arm will be accrued for this study within 4 years
Primary
Compare the induction of apoptosis as determined by TUNEL in the ovarian epithelial and stromal cells of participants at high risk for ovarian cancer treated with fenretinide vs placebo
Secondary
Compare modulation of several intermediate markers TGFβ BAX Ki-67 ER PR RARβ TGFβRI TGFβRII p21 p53 FAS and FASL in participants treated with these regimens
Compare early microvascular changes using contrast-enhanced ultrasound in participants treated with these drugs
Determine whether the use of contrast agents could indicate changes in ovarian size and architecture that may be assessed as potential surrogates for preventive effect in these participants
Determine the feasibility of future chemoprevention trials for ovarian cancer
Determine the toxicity of fenretinide in these participants
Compare the microvascularity index and ovarian volume of participants treated with these drugs
Correlate areas of increased microvascularity and other abnormalities with pathology findings obtained at oophorectomy in participants treated with these drugs
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Participants are randomized to 1 of 2 treatment arms
Arm I Participants receive oral fenretinide once daily
Arm II Participants receive oral placebo once daily In both arms treatment continues for 6-8 weeks in the absence of unacceptable toxicity
Within 5 days after completion of fenretinide or placebo participants undergo bilateral salpingo-oophorectomy
Participants are followed at 6 weeks
PROJECTED ACCRUAL A total of 40 participants 20 per treatment arm will be accrued for this study within 4 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 |
|---|---|---|---|
| MDA-GYN-01021 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA016672 |
| P30CA016672 | NIH | None | None |
| UARIZ-GYN-01021 | None | None | None |
| UARIZ-HSC-02190 | None | None | None |