Celecoxib in Preventing Cancer in Patients at High Risk for Ovarian Epithelial Cancer Who Are Undergoing Prophylactic Oophorectomy

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.

• celecoxib (Drug): Patients receive ora celecoxib twice daily for 3 months prior to prophylactic oophorectomy.
• oophorectomy (Procedure)

Primary outcomes

• Alteration in the histologic and molecular alterations in tissue biomarkers between patients at high risk for ovarian cancer treated with Celecoxib and treated without Celecoxib both having prophylactic oophorectomy. [baseline (day of surgery) and 2 years]

Secondary outcomes

• Alteration in gene expression between group I and group II [from baseline (surgery) to 2 years]

Sex: Female, ages: 19 Years to any

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

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