Status:
WITHDRAWN
Celecoxib in Preventing Cancer in Patients at High Risk for Ovarian Epithelial Cancer Who Are Undergoing Prophylactic Oophorectomy
Lead Sponsor:
University of Alabama at Birmingham
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
brca1 Mutation Carrier
brca2 Mutation Carrier
Eligibility:
FEMALE
19+ years
Phase:
NA
Brief Summary
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 ...
Detailed Description
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 pr...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2005
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00084370
Start Date
June 1 2002
End Date
March 1 2005
Last Update
August 22 2013
Active Locations (1)
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1
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294-3300