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

2014-08-27 03:54:19 | BioPortfolio

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: Phase II trial to study the effectiveness of celecoxib in preventing cancer in patients at high-risk for ovarian epithelial cancer who are undergoing prophylactic oophorectomy.

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.

PROJECTED ACCRUAL: A total of 20 patients (10 per treatment group) will be accrued for this study within 2 years.

Study Design

Primary Purpose: Prevention

Conditions

brca1 Mutation Carrier

Intervention

celecoxib, oophorectomy

Location

University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham
Alabama
United States
35294-3300

Status

Active, not recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:54:19-0400

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