An interventional study of celecoxib and oophorectomy in brca1 Mutation Carrier, brca2 Mutation Carrier and Ovarian Cancer, sponsored by University of Alabama at Birmingham. Withdrawn at 1 site in United States. Open to female participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2013-08-22.
Sponsored by University of Alabama at Birmingham · Not applicable, Interventional, and Prevention
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.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a pilot study. Patients are assigned to 1 of 2 treatment groups.
2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.
Browse Ovarian Neoplasms studies →University of Alabama at Birmingham is the lead sponsor of 1,397 studies on the registry; 285 are open to participants now.
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DISEASE CHARACTERISTICS:
At high risk for ovarian cancer and meets criteria for 1 of the following:
Family history of at least 2 ovarian** or breast cancers* among the patient and first- or second-degree relatives in the same lineage
NOTE: **In relatives, only ovarian epithelial cancer, fallopian tube cancer, and primary papillary serous cancer qualifies as ovarian cancer
No prior or concurrent ovarian cancer, including low malignant potential cancers or primary papillary serous carcinoma of the peritoneum
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Group I: Patients receive oral celecoxib twice daily for 3 months and then undergo prophylactic oophorectomy.
Drug: celecoxib · Procedure: oophorectomy
Group II: Patients undergo immediate prophylactic oophorectomy.
Procedure: oophorectomy
Patients receive ora celecoxib twice daily for 3 months prior to prophylactic oophorectomy.
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
Alteration in gene expression between group I and group II
Time frame: from baseline (surgery) to 2 years
This study is withdrawn, as verified in Aug 2013. You cannot join it, but the record below documents what was studied.
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University of Alabama at Birmingham