Celecoxib in Preventing Cancer in Patients at High Risk for Ovarian Epithelial Cancer Who Are Undergoing Prophylactic Oophorectomy

Not Applicable

Withdrawn

• Conditions: brca1 Mutation Carrier; brca2 Mutation Carrier; Ovarian Cancer
• Interventions: Drug: celecoxib; Procedure: oophorectomy

• Registration Number: NCT00084370
• Lead Sponsor: University of Alabama at Birmingham

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.

Study Timeline

• Study Start: 2002-06
• Study First Submitted: 2004-06-10
• Study First Submitted QC: 2004-06-10
• Study First Posted: 2004-06-11
• Primary Completion: 2005-03
• Study Completion: 2005-03
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-21
• Last Update Posted: 2013-08-22

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	oophorectomy	Group I: Patients receive oral celecoxib twice daily for 3 months and then undergo prophylactic oophorectomy.
Group II	oophorectomy	Group II: Patients undergo immediate prophylactic oophorectomy.
Group 1	celecoxib	Group I: Patients receive oral celecoxib twice daily for 3 months and then undergo prophylactic oophorectomy.

Primary Outcome Measures

Name	Time	Method
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.	baseline (day of surgery) and 2 years

Secondary Outcome Measures

Name	Time	Method
Alteration in gene expression between group I and group II	from baseline (surgery) to 2 years

Trial Locations

Locations (1)

University of Alabama at Birmingham Comprehensive Cancer Center; 🇺🇸 Birmingham, Alabama, United States