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)
- 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
- 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
- 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
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.
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Prevention
Molly A. Brewer, MD, DVM, MS
University of Arizona
United States: Food and Drug Administration
|Arizona Cancer Center at University of Arizona Health Sciences Center||Tucson, Arizona 85724|