Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Birmingham, Alabama 35294


Purpose:

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.


Study summary:

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.


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


NCT ID:

NCT00084370


Primary Contact:

Principal Investigator
Edward E. Partridge, MD
University of Alabama at Birmingham


Backup Contact:

N/A


Location Contact:

Birmingham, Alabama 35294
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 12, 2017

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.