Patient case: 72-year-old male with Cholangiocarcinoma. Genetic variant: BRCA2. Other conditions: Diabetes.

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.

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 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: 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

Relevance to patient case: not relevant