Ovarian Cancer Clinical Trial
Celecoxib in Preventing Cancer in Patients at High Risk for Ovarian Epithelial Cancer Who Are Undergoing Prophylactic Oophorectomy
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 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.
Full 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 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.
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
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There is 1 Location for this study
Birmingham Alabama, 35294, United States
How clear is this clinincal trial information?
Please confirm you are a US based health care provider:
Yes, I am a health care Provider No, I am not a health care providerSign Up Now.
Take Control of Your Disease Journey.
Sign up now for expert patient guides, personalized treatment options, and cutting-edge insights that can help you push for the best care plan.