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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Ovarian Cancer, brca1 Mutation Carrier, brca2 Mutation Carrier

Intervention / Treatment
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* Drug: celecoxib
* Procedure: oophorectomy


Participation Criteria
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Eligibility Criteria
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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 Multiple primary cancers in the same person may fulfill this requirement Ashkenazi Jewish ethnicity AND 1 first-degree or 2 second-degree relatives with breast* or ovarian** cancer Ashkenazi Jewish ethnicity AND had prior breast cancer* BRCA1/BRCA2 mutation probability > 20% by BRCAPRO Positive for BRCA1 or BRCA2 mutation First- or second-degree relative with a BRCA1/BRCA2 mutation NOTE: *At least 1 breast cancer must be premenopausal (diagnosed at age 50 or under if menopausal status unknown); ductal carcinoma in situ qualifies as breast cancer 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 No clinical evidence of ovarian cancer by physical examination, CA 125 evaluation, and pelvic ultrasound PATIENT CHARACTERISTICS: Age 19 and over Performance status GOG 0-1 Life expectancy Not specified Hematopoietic WBC > 3,000/mm^3 Granulocyte count > 1,500/mm^3 Platelet count > 100,000/mm^3 No hemophilia or other bleeding disorder No serious anemia Hepatic Transaminases normal Bilirubin normal Renal Creatinine clearance > 80 mL/min OR Creatinine < 2.0 mg/dL Pulmonary No emphysema Other Not pregnant or nursing No psychiatric or psychological condition that would preclude giving informed consent No concurrent untreated malignancy except nonmelanoma skin cancer No other medical condition that would preclude blood draws (e.g., chronic infectious disease) PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy More than 3 months since prior adjuvant chemotherapy Endocrine therapy Concurrent adjuvant hormonal therapy (e.g., tamoxifen, leuprolide, or goserelin) allowed Radiotherapy More than 3 months since prior adjuvant radiotherapy Surgery More than 3 months since prior intraperitoneal surgery (laparoscopy or laparotomy) No prior oophorectomy Other More than 5 years since prior treatment (excluding hormonal therapy) for metastatic malignancy No concurrent participation in other ovarian cancer early detection clinical trials

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>Group I: Patients receive oral celecoxib twice daily for 3 months and then undergo prophylactic oophorectomy. | Drug: celecoxib<br>* Patients receive ora celecoxib twice daily for 3 months prior to prophylactic oophorectomy.<br>Procedure: oophorectomy<br> <br> |
| Experimental: Group II<br>Group II: Patients undergo immediate prophylactic oophorectomy. | Procedure: oophorectomy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alteration in gene expression between group I and group II |  | from baseline (surgery) to 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ovarian epithelial cancer, BRCA1 mutation carrier, BRCA2 mutation carrier