Celecoxib in Preventing Cancer in Patients at High Risk for Ovarian Epithelial Cancer Who Are Undergoing Prophylactic Oophorectomy
brca1 Mutation Carrier, brca2 Mutation Carrier, Ovarian Cancer
About this trial
This is an interventional prevention trial for brca1 Mutation Carrier focused on measuring ovarian epithelial cancer, BRCA1 mutation carrier, BRCA2 mutation carrier
Eligibility Criteria
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
Sites / Locations
- University of Alabama at Birmingham Comprehensive Cancer Center
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Group 1
Group II
Group I: Patients receive oral celecoxib twice daily for 3 months and then undergo prophylactic oophorectomy.
Group II: Patients undergo immediate prophylactic oophorectomy.