Effect of Flutamide on Biomarkers in Blood and Tissue Samples From Patients at High Risk of Ovarian Cancer
Condition: Ovarian Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Intervention: flutamide
Intervention description: Patients receive oral flutamide (125 MG/DAY) once daily for 6 weeks in the absence of unacceptable toxicity.
Intervention MeSH terms: Flutamide
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 127.0
Sex: Female
Minimum age: 18 Years
Maximum age: 83 Years
Healthy volunteers: No
Keywords: Ovarian epithelial cancer; High risk; Biomarkers

Summary:

      Studying samples of blood and tissue in the laboratory from patients with a high risk of
      developing ovarian cancer may help doctors identify and learn more about biomarkers related
      to cancer. We hypothesized that (i) preclinical biologic evidence exists for the role of
      androgens in ovarian cancer development and (ii) flutamide treatment of women at high risk
      for ovarian cancer may identify meaningful tissue biomarkers of androgen action and of
      ovarian cancer initiation. This phase II trial studied the effect of flutamide on biomarkers
      in blood and tissue samples from patients at high risk of ovarian cancer.
    

Eligibility criteria:

        Inclusion Criteria for all patients:

          -  ≥ 18 years of age

          -  Able to comply with study and follow-up requirements

        Inclusion Criteria for high risk patients:

          -  elected to undergo prophylactic salpingo-oophorectomy

          -  fertile patients must use effective non-hormonal contraception

          -  agreed to use a nonhormonal means of contraception before surgery

          -  serum bilirubin ≤ 1.0 x Upper Limit Normal (ULN), alkaline phosphatase, Aspartate
             Aminotransferase (AST), and Alanine Aminotransferase (ALT) ≤ 2.5 x ULN

          -  serum creatinine ≤ 1.5 x ULN

          -  granulocyte count ≥ 1500/μL

          -  platelet count ≥ 75,000/μL

          -  hemoglobin ≥ 9 g/dL

          -  adequate complete blood count

          -  At high risk for developing ovarian cancer, as defined by any of the following:

          -  Breast Cancer carried a BRCA1 or BRCA2 deleterious mutation, a Lynch syndrome
             mutation, and/or defined by a family history of: 1 first-degree relative with
             epithelial ovarian cancer, ≥1 first-degree female relative with breast cancer when ≤40
             years old, ≥1 first-degree female relative with breast cancer when ≤50 years old, male
             relative with breast cancer, and/or family history of breast cancer or ovarian cancer.

        Inclusion Criteria for low risk patients:

          -  planning to undergo oophorectomy for a medical indication

          -  did not fulfill criteria for high risk of developing ovarian cancer

        Exclusion criteria:

          -  liver disease, current alcohol abuse, or cirrhosis

          -  pregnancy or lactation

          -  current use of hormone therapy

          -  active treatment for cancer

          -  recent, current, or planned participation in another experimental drug study

          -  breast cancer within the past 5 years

          -  significant traumatic injury within the past 6 months

          -  major surgery within the past 6 months

          -  any disease, 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