Status:
COMPLETED
Effect of Flutamide on Biomarkers in Blood and Tissue Samples From Patients at High Risk of Ovarian Cancer
Lead Sponsor:
University of Arizona
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Ovarian Cancer
Eligibility:
FEMALE
18-83 years
Phase:
PHASE2
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 hypot...
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 c...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
127 Patients enrolled
Trial Details
Trial ID
NCT00699907
Start Date
January 1 2005
End Date
November 1 2014
Last Update
July 24 2018
Active Locations (1)
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1
University of Arizona Cancer Center
Tucson, Arizona, United States, 85724-5024