Effect of Flutamide on Biomarkers in Blood and Tissue Samples From Patients at High Risk of Ovarian Cancer
NCT ID: NCT00699907
Last Updated: 2018-07-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
127 participants
INTERVENTIONAL
2005-01-31
2014-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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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.
flutamide
Patients receive oral flutamide (125 MG/DAY) once daily for 6 weeks in the absence of unacceptable toxicity.
High Risk Arm
High risk patients underwent risk-reducing salpingo-oophorectomy.
No interventions assigned to this group
Low Risk Arm
Low risk patients underwent salpingo-oophorectomy for a medical indication.
No interventions assigned to this group
Interventions
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flutamide
Patients receive oral flutamide (125 MG/DAY) once daily for 6 weeks in the absence of unacceptable toxicity.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Able to comply with study and follow-up requirements
* 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.
* planning to undergo oophorectomy for a medical indication
* did not fulfill criteria for high risk of developing ovarian cancer
Exclusion Criteria
* 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
18 Years
83 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of Arizona
OTHER
Responsible Party
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Principal Investigators
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Setsuko K. Chambers, MD
Role: PRINCIPAL_INVESTIGATOR
University of Arizona Arizona Cancer Center
Locations
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University of Arizona Cancer Center
Tucson, Arizona, United States
Countries
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References
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Gruessner C, Gruessner A, Glaser K, AbuShahin N, Zhou Y, Laughren C, Wright H, Pinkerton S, Yi X, Stoffer J, Azodi M, Zheng W, Chambers SK. Flutamide and biomarkers in women at high risk for ovarian cancer: preclinical and clinical evidence. Cancer Prev Res (Phila). 2014 Sep;7(9):896-905. doi: 10.1158/1940-6207.CAPR-13-0408. Epub 2014 Jun 20.
Related Links
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American Journal of Cancer Research, 2014.
Other Identifiers
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04-0707-04
Identifier Type: -
Identifier Source: org_study_id
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