NCT00084370

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

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: Female
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Conditions

• brca1 Mutation Carrier
• brca2 Mutation Carrier
• Ovarian Cancer

Interventions

Type	Name	Description
DRUG	celecoxib	Patients receive ora celecoxib twice daily for 3 months prior to prophylactic oophorectomy.
PROCEDURE	oophorectomy

Timeline

• Start date: 2002-06-01
• Primary completion: 2005-03-01
• Completion: 2005-03-01
• First posted: 2004-06-11
• Last updated: 2013-08-22

Locations

1 site across 1 country: United States