A Prospective, Phase IIA Study of the Effect of Flutamide (125 MG/DAY) Taken for 6 Weeks on Expression of Potential Biomarkers of Flutamide Action in the Ovaries of Women at Increased Risk for Ovarian Cancer
- Identify biomarkers of flutamide action in ovarian epithelial cells after 6 weeks of
treatment with flutamide in patients at high risk for ovarian cancer.
- Examine the effect of flutamide in these patients.
- Compare the results of this pilot study in patients at high risk for ovarian cancer who
are undergoing prophylactic oophorectomy and are interested in taking flutamide vs
patients at high risk for ovarian cancer who are undergoing prophylactic oophorectomy
and are not interested in taking flutamide (control) vs patients who are undergoing
oophorectomy for a medical indication (control).
OUTLINE: Patients who elect not to receive flutamide undergo prophylactic oophorectomy or
oophorectomy for a medical indication. Patients who elect to receive flutamide are
randomized to 125mg/day.
Interested patients who elect to receive flutamide receive oral flutamide once daily for 6
weeks in the absence of unacceptable toxicity. Patients then undergo prophylactic
All patients undergo blood and ovarian tissue sample collection at the time of surgery for
biomarker laboratory studies. Proteomic, microarray, and polymorphism analysis are performed
on the blood and tissue samples.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Effect of of flutamide in ovarian tissue
at time ovaries are removed and testing is done on specimens
Setsuko K. Chambers, MD
University of Arizona
United States: Food and Drug Administration
|Arizona Cancer Center at University of Arizona Health Sciences Center||Tucson, Arizona 85724|