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

Molecular Alterations in Human Ovarian Epithelium Induced by Chemopreventive Agents in Patients at Elevated Inherited Risk of Ovarian Cancer: A Controlled Pilot Study in Ovarian Cancer Chemoprevention

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00084370
Enrollment
0
Registered
2004-06-11
Start date
2002-06-30
Completion date
2005-03-31
Last updated
2013-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

brca1 Mutation Carrier, brca2 Mutation Carrier, Ovarian Cancer

Keywords

ovarian epithelial cancer, BRCA1 mutation carrier, BRCA2 mutation carrier

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 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.

Interventions

DRUGcelecoxib

Patients receive ora celecoxib twice daily for 3 months prior to prophylactic oophorectomy.

PROCEDUREoophorectomy

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
University of Alabama at Birmingham
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
19 Years to No maximum
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Alteration in gene expression between group I and group IIfrom baseline (surgery) to 2 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026