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
Overview
- Phase
- Not Applicable
- Intervention
- celecoxib
- Conditions
- brca1 Mutation Carrier
- Sponsor
- University of Alabama at Birmingham
- Locations
- 1
- Primary Endpoint
- Alteration in the histologic and molecular alterations in tissue biomarkers between patients at high risk for ovarian cancer treated with Celecoxib and treated without Celecoxib both having prophylactic oophorectomy.
- Status
- Withdrawn
- Last Updated
- 12 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Edward Partridge
Principal Investigator
University of Alabama at Birmingham
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Group 1
Group I: Patients receive oral celecoxib twice daily for 3 months and then undergo prophylactic oophorectomy.
Intervention: celecoxib
Group 1
Group I: Patients receive oral celecoxib twice daily for 3 months and then undergo prophylactic oophorectomy.
Intervention: oophorectomy
Group II
Group II: Patients undergo immediate prophylactic oophorectomy.
Intervention: oophorectomy
Outcomes
Primary Outcomes
Alteration in the histologic and molecular alterations in tissue biomarkers between patients at high risk for ovarian cancer treated with Celecoxib and treated without Celecoxib both having prophylactic oophorectomy.
Time Frame: baseline (day of surgery) and 2 years
Secondary Outcomes
- Alteration in gene expression between group I and group II(from baseline (surgery) to 2 years)