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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Arizona
ClinicalTrials.gov Identifier:
NCT00699907
First received: June 17, 2008
Last updated: April 14, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Ovarian Cancer
Drug: flutamide
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by University of Arizona:

Primary Outcome Measures:
  • Effect of of flutamide in ovarian tissue [ Time Frame: at time ovaries are removed and testing is done on specimens ] [ Designated as safety issue: No ]
  • 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 ... [ Time Frame: at time ovarian specimens are processed ] [ Designated as safety issue: No ]

Estimated Enrollment: 140
Study Start Date: January 2005
Estimated Study Completion Date: October 2014
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
Patients receive oral flutamide once daily for 6 weeks in the absence of unacceptable toxicity. Patients then undergo prophylactic oophorectomy.
Drug: flutamide
Given orally

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00699907

Locations
United States, Arizona
Arizona Cancer Center at University of Arizona Health Sciences Center
Tucson, Arizona, United States, 85724-5024
Sponsors and Collaborators
University of Arizona
Investigators
Principal Investigator: Setsuko K. Chambers, MD University of Arizona
  More Information

Additional Information:
No publications provided by University of Arizona

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Arizona
ClinicalTrials.gov Identifier: NCT00699907     History of Changes
Other Study ID Numbers: 04-0707-04, P30CA023074, UARIZ-04-0707-04, UARIZ-HSC04184, UARIZ-SRC17834
Study First Received: June 17, 2008
Last Updated: April 14, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Arizona:
ovarian epithelial cancer

Additional relevant MeSH terms:
Ovarian Neoplasms
Adnexal Diseases
Endocrine Gland Neoplasms
Endocrine System Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms
Neoplasms by Site
Ovarian Diseases
Urogenital Neoplasms
Flutamide
Androgen Antagonists
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014