Ovarian Cancer Clinical Trial
Official title:
Molecular Alterations in Human Ovarian Epithelium Induced by Chemopreventive Agents in Patients at Elevated Inherited Risk of Ovarian Cancer: A Controlled Pilot Study in Ovarian Cancer Chemoprevention
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the
development or recurrence of cancer. The use of celecoxib before prophylactic oophorectomy
may be an effective way to prevent the development of ovarian epithelial cancer.
PURPOSE: A controlled pilot trial to study the effectiveness of celecoxib in preventing
cancer in patients at high-risk for ovarian epithelial cancer who are undergoing
prophylactic oophorectomy.
OBJECTIVES:
Primary
- Compare histologic and molecular alterations in tissue biomarkers of patients at high
risk for ovarian cancer treated with celecoxib followed by prophylactic oophorectomy vs
prophylactic oophorectomy only.
Secondary
- Compare alterations in gene expression pattern in patients treated with these regimens.
OUTLINE: This is a pilot study. Patients are assigned to 1 of 2 treatment groups.
- Group I: Patients receive oral celecoxib twice daily for 3 months and then undergo
prophylactic oophorectomy.
- Group II: Patients undergo immediate prophylactic oophorectomy.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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