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
brca1 Mutation Carrier, brca2 Mutation Carrier, Ovarian Cancer
About this trial
This is an interventional prevention trial for brca1 Mutation Carrier focused on measuring ovarian epithelial cancer, BRCA1 mutation carrier, BRCA2 mutation carrier
Eligibility Criteria
DISEASE CHARACTERISTICS: At high risk for developing ovarian cancer, meeting 1 of the following criteria: Family history of ovarian cancer, defined as ≥ 1 first-degree relative diagnosed with ovarian cancer before 50 years of age Family history of ovarian cancer, defined as ≥ 1 first-degree relative diagnosed with ovarian cancer at any age AND ≥ 1 first- or second-degree relative diagnosed with breast or ovarian cancer at any age Positive BRCA1/BRCA2 test Planning to undergo prophylactic bilateral oophorectomy PATIENT CHARACTERISTICS: Age 30 and over Performance status Zubrod 0-1 Life expectancy At least 12 months Hematopoietic Not specified Hepatic Bilirubin ≤ 1.5 times upper limit of normal (ULN) SGOT ≤ 1.5 times ULN Alkaline phosphatase ≤ 1.5 times ULN No history of liver disease* No cholestatic jaundice No hepatic adenomas NOTE: *For patients undergoing contrast enhanced ultrasound Renal BUN normal Creatinine normal Cardiovascular No history of a congenital heart defect creating a bi-directional or right-to-left shunt* No history of congestive heart failure* No thrombophlebitis No thromboembolic disease No cerebral vascular disease No coronary artery disease NOTE: *For patients undergoing contrast enhanced ultrasound Pulmonary No history of pulmonary hypertension* No history of pulmonary emboli* No history of severe emphysema* NOTE: *For patients undergoing contrast enhanced ultrasound Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective barrier contraception Thyroid stimulating hormone normal T4 normal Triglycerides ≤ 1.5 times ULN No malignancy within the past 5 years except breast cancer or basal cell or squamous cell skin cancer No evidence of recurrent disease No known or suspected hypersensitivity to blood, blood products, or albumin No undiagnosed genital bleeding No history of pancreatitis No uncontrolled diabetes No other severe underlying chronic disease No concurrent alcohol use (> 3 drinks/day or equivalent) PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy At least 3 months since prior chemotherapy for breast cancer Endocrine therapy No concurrent selective estrogen-receptor modulators, including raloxifene No concurrent aromatase inhibitors Radiotherapy Not specified Surgery See Disease Characteristics Other More than 3 months since prior therapeutic oral or topical vitamin A derivatives (e.g., isotretinoin) No other concurrent investigational agents No concurrent cyclooxygenase-2 (COX-2) inhibitors No concurrent oral vitamin A or ascorbic acid (vitamin C) supplements > recommended daily requirement (10,000 IU for vitamin A and 75 mg for vitamin C)
Sites / Locations
- Arizona Cancer Center at University of Arizona Health Sciences Center