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Celecoxib in Preventing Cancer in Patients at High Risk for Ovarian Epithelial Cancer Who Are Undergoing Prophylactic Oophorectomy
This study is ongoing, but not recruiting participants.
Study NCT00084370   Information provided by National Cancer Institute (NCI)
First Received: June 10, 2004   Last Updated: May 30, 2009   History of Changes

June 10, 2004
May 30, 2009
June 2002
 
 
Complete list of historical versions of study NCT00084370 on ClinicalTrials.gov Archive Site
 
 
 
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

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.

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.

Phase II
Interventional
Prevention
  • brca1 Mutation Carrier
  • brca2 Mutation Carrier
  • Ovarian Cancer
  • Drug: celecoxib
  • Procedure: oophorectomy
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
 
 
 

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
Female
19 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00084370
 
CDR0000352114, UAB-0134
University of Alabama at Birmingham
National Cancer Institute (NCI)
Principal Investigator: Edward E. Partridge, MD University of Alabama at Birmingham
National Cancer Institute (NCI)
September 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP