Celecoxib in Preventing Cancer in Patients at High Risk for Ovarian Epithelial Cancer Who Are Undergoing Prophylactic Oophorectomy
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.
brca1 Mutation Carrier
brca2 Mutation Carrier
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|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|
- 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 ] [ Designated as safety issue: No ]
- Alteration in gene expression between group I and group II [ Time Frame: from baseline (surgery) to 2 years ] [ Designated as safety issue: No ]
|Study Start Date:||June 2002|
|Study Completion Date:||March 2005|
|Primary Completion Date:||March 2005 (Final data collection date for primary outcome measure)|
Experimental: Group 1
Group I: Patients receive oral celecoxib twice daily for 3 months and then undergo prophylactic oophorectomy.
Patients receive ora celecoxib twice daily for 3 months prior to prophylactic oophorectomy.Procedure: oophorectomy
Experimental: Group II
Group II: Patients undergo immediate prophylactic oophorectomy.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00084370
|United States, Alabama|
|University of Alabama at Birmingham Comprehensive Cancer Center|
|Birmingham, Alabama, United States, 35294-3300|
|Principal Investigator:||Edward E. Partridge, MD||University of Alabama at Birmingham|