An Exploratory Evaluation of Fenretinide (4-HPR) as a Chemopreventive Agent for Ovarian Carcinoma

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Increased risk for ovarian cancer secondary to 1 of the following:

- Evidence of a BRCA1 or BRCA2 genetic mutation

- Family history of 1 or more first-degree relatives diagnosed with ovarian cancer
prior to 50 years of age

- Family history of 1 first-degree relative with ovarian cancer (any age) AND 1 or
more first- or second-degree relatives diagnosed with breast or ovarian cancer

- Personal history of breast cancer (at any age) AND 1 or more first- or
second-degree relative diagnosed with breast or ovarian cancer at any age

- Meets any 1 of the following criteria:

- Ashkenazi Jewish ethnicity with 1 first-degree or 2 second-degree relatives with
breast* and/or ovarian cancer

- Ashkenazi Jewish ethnicity with diagnosed breast* cancer in patient

- Greater than 20% probability of carrying BRCA1/2 mutation with a family history
of breast and ovarian cancer NOTE: * Where breast cancer is required to meet
this criteria, diagnosis must occur prior to menopause or at ≤ 50 years old if
age at menopause is unknown

- Planned prophylactic oophorectomy

- Normal pelvic exam within the past 6 weeks

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- GOG 0-1

Life expectancy:

- At least 12 months

Hematopoietic:

- WBC at least 4,000/mm^3

- Platelet count at least 100,000/mm^3

Hepatic:

- Bilirubin no greater than 1.5 mg/dL

- SGOT no greater than 2 times upper limit of normal (ULN)

Renal:

- Creatinine no greater than 1.5 mg/dL OR

- Creatinine clearance at least 60 mL/min

- Triglyceride less than 2 times ULN (fasting)

Cardiovascular:

- No myocardial infarction within the past 3 months

- No active angina

- No unstable heart rhythms

- No clinically evident congestive heart failure

Other:

- No uncontrolled medical illness that would preclude study participation

- No uncontrolled diabetes

- No uncontrolled psychiatric illness

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective barrier contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- At least 3 months since prior chemotherapy

Endocrine therapy:

- At least 3 months since prior hormonal therapy

- At least 8 weeks since prior hormone replacement therapy

- At least 8 weeks since prior oral, injectable, or implantable contraceptives

- No concurrent hormonal therapy, including hormone replacement therapy

Radiotherapy:

- At least 3 months since prior radiotherapy

- No prior radiotherapy to pelvis for malignancy

Surgery:

- See Disease Characteristics

Other:

- At least 3 months since prior investigational treatment

- No concurrent nutritional supplements except a daily multivitamin with less than
25,000 IU of vitamin A

- No prior non-steroidal anti-inflammatory drugs (NSAIDs) on a regular (chronic or
daily) basis within the past 6 months

- No concurrent NSAIDs on a regular (chronic or daily) basis

- Concurrent aspirin at a dose of 81 mg/day allowed