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Sponsors and Collaborators: |
Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00084370 |
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.
Condition | Intervention | Phase |
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brca1 Mutation Carrier brca2 Mutation Carrier Ovarian Cancer |
Drug: celecoxib Procedure: oophorectomy |
Phase II |
Study Type: | Interventional |
Study Design: | 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 |
Study Start Date: | June 2002 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a pilot study. Patients are assigned to 1 of 2 treatment groups.
PROJECTED ACCRUAL: A total of 20 patients (10 per treatment group) will be accrued for this study within 2 years.
Ages Eligible for Study: | 19 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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
United States, Alabama | |
University of Alabama at Birmingham Comprehensive Cancer Center | |
Birmingham, Alabama, United States, 35294-3300 |
Principal Investigator: | Edward E. Partridge, MD | Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham |
Study ID Numbers: | CDR0000352114, UAB-0134 |
Study First Received: | June 10, 2004 |
Last Updated: | August 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00084370 |
Health Authority: | United States: Federal Government |
ovarian epithelial cancer BRCA1 mutation carrier BRCA2 mutation carrier |
Genital Diseases, Female Ovarian cancer Celecoxib Ovarian Neoplasms Gonadal Disorders Genital Neoplasms, Female |
Endocrine System Diseases Urogenital Neoplasms Endocrinopathy Ovarian Diseases Ovarian epithelial cancer Endocrine Gland Neoplasms |
Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Cyclooxygenase Inhibitors Physiological Effects of Drugs Enzyme Inhibitors Pharmacologic Actions Adnexal Diseases Neoplasms Neoplasms by Site |
Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |