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

Date de début de l'étude : 1 juin 2002

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