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
celecoxib
+ oophorectomy
Carcinoma, Ovarian Epithelial+16
+ Urogenital Diseases
+ Genital Diseases
Prevention Study
Summary
Study start date: June 1, 2002
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Prevention Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.Over 19 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, United StatesOpen University of Alabama at Birmingham Comprehensive Cancer Center in Google Maps