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

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ClinicalTrials.gov Identifier: NCT00699907
Recruitment Status : Completed
First Posted : June 18, 2008
Results First Posted : January 5, 2018
Last Update Posted : January 5, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Arizona

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Drug: flutamide Phase 2

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 127 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : January 2005
Actual Primary Completion Date : November 2012
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer
Drug Information available for: Flutamide

Arm Intervention/treatment
Active Comparator: Treatment Arm
Patients received oral flutamide (125 MG) once daily for 6 weeks in the absence of unacceptable toxicity. Patients then underwent risk-reducing salpingo-oophorectomy.
Drug: flutamide
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

No Intervention: High Risk Arm
High risk patients underwent risk-reducing salpingo-oophorectomy.
No Intervention: Low Risk Arm
Low risk patients underwent salpingo-oophorectomy for a medical indication.



Primary Outcome Measures :
  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).



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Ages Eligible for Study:   18 Years to 83 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00699907


Locations
United States, Arizona
University of Arizona Cancer Center
Tucson, Arizona, United States, 85724-5024
Sponsors and Collaborators
University of Arizona
National Cancer Institute (NCI)
Investigators
Principal Investigator: Setsuko K. Chambers, MD University of Arizona Arizona Cancer Center

Additional Information:
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 ( U.S. NIH Grant/Contract )
First Posted: June 18, 2008    Key Record Dates
Results First Posted: January 5, 2018
Last Update Posted: January 5, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Arizona:
Ovarian epithelial cancer
High risk
Biomarkers

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