Fenretinide Followed by Surgery Compared With Surgery Alone in Preventing Ovarian Cancer in Patients at Increased Risk

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