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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


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Ovarian Cancer

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Trial Information

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


OBJECTIVES:

- 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
oophorectomy.

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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Effect of of flutamide in ovarian tissue

Outcome Time Frame:

at time ovaries are removed and testing is done on specimens

Safety Issue:

No

Principal Investigator

Setsuko K. Chambers, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Arizona

Authority:

United States: Food and Drug Administration

Study ID:

04-0707-04

NCT ID:

NCT00699907

Start Date:

January 2005

Completion Date:

February 2013

Related Keywords:

  • Ovarian Cancer
  • ovarian epithelial cancer
  • Ovarian Neoplasms

Name

Location

Arizona Cancer Center at University of Arizona Health Sciences CenterTucson, Arizona  85724