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


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Familial Multiple Endocrine Neoplasia


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.

Sponsors and Collaborators: UAB Comprehensive Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)

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

Further Study Details: 

OBJECTIVES: Primary

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.

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

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

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

Study chairs or principal investigators

Edward E. Partridge, MD,  Principal Investigator,  UAB Comprehensive Cancer Center   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000352114; UAB-0134
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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August 29, 2008



Page Updated: October 3, 2005
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