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
|ClinicalTrials.gov Identifier: NCT00098800|
Recruitment Status : Completed
First Posted : December 9, 2004
Last Update Posted : March 24, 2010
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.
|Condition or disease||Intervention/treatment|
|brca1 Mutation Carrier brca2 Mutation Carrier Ovarian Cancer||Drug: fenretinide|
- 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.
- 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|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)|
|Study Start Date :||October 2004|
|Primary Completion Date :||August 2006|
|Study Completion Date :||November 2006|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00098800
|United States, Arizona|
|Arizona Cancer Center at University of Arizona Health Sciences Center|
|Tucson, Arizona, United States, 85724-5024|
|Principal Investigator:||Molly A. Brewer, MD, DVM, MS||University of Arizona|