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Completed

NCT Number: NCT00699907

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

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.

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Key information

Conditions

Ovarian Cancer Adnexal Diseases Carcinoma Carcinoma, Ovarian Epithelial Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Ovarian Diseases Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year–83 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

University of Arizona Cancer Center

Tucson, Arizona, 85724-5024, United States

About this study

OBJECTIVE: Compare the biomarkers of 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 elected not to receive flutamide received prophylactic oophorectomy or oophorectomy for a medical indication. Patients who elected to receive flutamide received 125mg once daily for 6 weeks in the absence of unacceptable toxicity. Patients then underwent prophylactic oophorectomy. All patients underwent blood and ovarian tissue sample collection at the time of surgery for biomarker laboratory studies. Proteomic, microarray, and polymorphism analysis were performed on the blood and tissue samples.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

flutamide

Drug

Patients receive oral flutamide (125 MG/DAY) once daily for 6 weeks in the absence of unacceptable toxicity.

Other names: Eulexin, Cytomid, Cebatrol, Chimax, Drogenil, Flucinom, Flutamin, Fugerel, Niftolide, Sebatrol

Primary outcomes

  1. Colony Stimulating Factor (CSF-1) Expression in Ovarian Endosalpingiosis

    Time frame: Surgery

    CSF-1 levels were measured by immunohistochemistry (IHC).

    The modified H-Score assess extent of nuclear immunoreactivity applicable to steroid receptors.

    The modified H-scores total range is 0-300. A lower modified H-score indicates weakly staining nuclei. A higher modified H-score indicated strongly staining nuclei.

    This applies to all measures.

  2. Colony Stimulating Factor (CSF-1) Expression in Ovarian Epithelium

    Time frame: Surgery

    CSF-1 levels were measured by immunohistochemistry (IHC).

  3. Colony Stimulating Factor (CSF-1) Expression in Ovarian Stroma

    Time frame: Surgery

    CSF-1 levels were measured by immunohistochemistry (IHC).

  4. Colony Stimulating Factor-1 Receptor (CSF-1R) Expression in Ovarian Endosalpingiosis

    Time frame: Surgery

    CSF-1R levels were measured by immunohistochemistry (IHC).

  5. Colony Stimulating Factor-1 Receptor (CSF-1R) Expression in Ovarian Epithelium

    Time frame: Surgery

    CSF-1R levels were measured by immunohistochemistry (IHC).

  6. Colony Stimulating Factor-1 Receptor (CSF-1R) Expression in Ovarian Stroma

    Time frame: Surgery

    CSF-1R levels were measured by immunohistochemistry (IHC).

  7. Tyrosine Kinase V-erb-b2 Erythroblastic Leukemia Viral Oncogene Homolog-4 (ErbB4) Expression in Ovarian Endosalpingiosis

    Time frame: Surgery

    ErbB4 levels were measured by immunohistochemistry (IHC).

  8. Tyrosine Kinase V-erb-b2 Erythroblastic Leukemia Viral Oncogene Homolog-4 (ErbB4) Expression in Ovarian Epithelium

    Time frame: Surgery

    ErbB4 levels were measured by immunohistochemistry (IHC).

  9. Tyrosine Kinase V-erb-b2 Erythroblastic Leukemia Viral Oncogene Homolog-4 (ErbB4) Expression in Ovarian Stroma

    Time frame: Surgery

    ErbB4 levels were measured by immunohistochemistry (IHC).

Sponsors and collaborators

Lead sponsor

University of Arizona

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2012
Study completion
2014
First posted
Jun 18, 2008
Registry last updated
Jul 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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