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

Condition(s) targeted: Ovarian Cancer

Intervention: flutamide (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: University of Arizona

Official(s) and/or principal investigator(s):
Setsuko K. Chambers, MD, Principal Investigator, Affiliation: University of Arizona

RATIONALE: 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. It may also help doctors learn more about the effects of flutamide on biomarkers.

PURPOSE: This phase II trial is studying the effect of flutamide on biomarkers in blood and tissue samples from patients at high risk of ovarian cancer.

Official title: 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

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

Primary outcome:

Effect of of flutamide in ovarian tissue

Comparison of 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 ...

Detailed description: 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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

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

Arizona Cancer Center at University of Arizona Health Sciences Center, Tucson, Arizona 85724-5024, United States; Recruiting
Arizona Cancer Center Division of Women's Cancers, Phone: 520-626-9283

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: January 2005
Last updated: August 3, 2011