Familial Multiple Endocrine Neoplasia |
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Clinical Trial: Celecoxib in Preventing Cancer in Patients at High Risk for Ovarian Epithelial Cancer Who Are Undergoing Prophylactic Oophorectomy
This study is no longer recruiting patients.
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: Phase II trial to study the effectiveness of celecoxib in preventing cancer in patients at high-risk for ovarian epithelial cancer who are undergoing prophylactic oophorectomy.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| ovarian epithelial cancer | Drug: celecoxib Procedure: ablative endocrine surgery Procedure: cancer prevention intervention Procedure: chemoprevention of cancer Procedure: endocrine therapy Procedure: oophorectomy | Phase II |
MedlinePlus related topics: Ovarian Cancer
Study Type: Interventional
Study Design: Prevention
Official Title: Phase II Study of Celecoxib in Patients at High Risk for Ovarian Epithelial Cancer 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.
PROJECTED ACCRUAL: A total of 20 patients (10 per treatment group) will be accrued for this study within 2 years.
Eligibility
Ages Eligible for Study: 19 Years and above, Genders Eligible for Study: Both
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
Location Information
Alabama
University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham, Alabama, 35294-3300, United States
Edward E. Partridge, MD, Principal Investigator, UAB Comprehensive Cancer Center
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Record last reviewed: October 2004
Last Updated: October 13, 2004
Record first received: June 10, 2004
ClinicalTrials.gov Identifier: NCT00084370
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 8, 2005

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