Effect of Flutamide on Biomarkers in Blood and Tissue Samples From Patients at High Risk of Ovarian Cancer

DISEASE CHARACTERISTICS:

• At high risk for developing ovarian cancer, as defined by any of the following:

  • Known inherited BRCA-1 or -2 mutation
  • Recognized familial breast/ovarian or ovarian cancer syndrome
  • Has at least one first-degree relative with ovarian cancer

  • Has a family history of breast cancer meeting 1 of the following criteria:

    • More than one relative with breast cancer AND < 50 years of age
    • Relative(s) with male breast cancer
    • One relative with breast cancer AND < 40 years of age

• Meets 1 of the following criteria:

  • Planning to undergo prophylactic oophorectomy AND is willing to receive flutamide
  • Planning to undergo prophylactic oophorectomy AND is not willing to receive flutamide (control)
  • Planning to undergo oophorectomy for a medical indication (control)
• No breast cancer within the past 5 years

PATIENT CHARACTERISTICS:

• Granulocyte count ≥ 1,500/µL
• Platelet count ≥ 75,000/µL
• Hemoglobin ≥ 9 g/dL
• Serum bilirubin normal
• AST and ALT ≤ 2.5 times upper limit of normal (ULN)
• Alkaline phosphatase ≤ 2.5 times ULN
• Serum creatinine ≤ 1.5 times ULN
• Not pregnant or nursing
• Fertile patients must use effective non-hormonal contraception
• Able to comply with study and follow-up requirements
• No liver disease, including cirrhosis or viral or other hepatitis
• No current alcohol abuse
• No significant traumatic injury within the past 6 months
• No disease, metabolic dysfunction, physical examination findings, or clinical laboratory findings giving reasonable suspicion of a disease or condition that contraindicates the continued use of an investigational drug or that may render the patient at high risk from treatment complication

PRIOR CONCURRENT THERAPY:

• More than 6 months since prior major surgery
• No other concurrent hormonal therapy
• No concurrent participation in another experimental drug study