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

June 27, 2018 updated by: University of Arizona

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

127

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85724-5024
        • University of Arizona Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 83 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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:
  • Cebatrol
  • Chimax
  • Cytomid
  • Drogenil
  • Flucinom
  • Flutamin
  • Fugerel
  • Niftolide
  • Eulexin
  • 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Surgery
Colony Stimulating Factor (CSF-1) Expression in Ovarian Epithelium
Time Frame: Surgery
CSF-1 levels were measured by immunohistochemistry (IHC).
Surgery
Colony Stimulating Factor (CSF-1) Expression in Ovarian Stroma
Time Frame: Surgery
CSF-1 levels were measured by immunohistochemistry (IHC).
Surgery
Colony Stimulating Factor-1 Receptor (CSF-1R) Expression in Ovarian Endosalpingiosis
Time Frame: Surgery
CSF-1R levels were measured by immunohistochemistry (IHC).
Surgery
Colony Stimulating Factor-1 Receptor (CSF-1R) Expression in Ovarian Epithelium
Time Frame: Surgery
CSF-1R levels were measured by immunohistochemistry (IHC).
Surgery
Colony Stimulating Factor-1 Receptor (CSF-1R) Expression in Ovarian Stroma
Time Frame: Surgery
CSF-1R levels were measured by immunohistochemistry (IHC).
Surgery
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).
Surgery
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).
Surgery
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).
Surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Arizona

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Setsuko K. Chambers, MD, University of Arizona Arizona Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Primary Completion (ACTUAL)

November 1, 2012

Study Completion (ACTUAL)

November 1, 2014

Study Registration Dates

First Submitted

June 17, 2008

First Submitted That Met QC Criteria

June 17, 2008

First Posted (ESTIMATE)

June 18, 2008

Study Record Updates

Last Update Posted (ACTUAL)

July 24, 2018

Last Update Submitted That Met QC Criteria

June 27, 2018

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 04-0707-04
  • P30CA023074 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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