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

• Status: Completed
• Trial end date: 2014-11-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Arizona
• Collaborator: National Cancer Institute (NCI)
• Treatments: Flutamide

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