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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.
Sponsors and Collaborators: Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00084370
  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 Intervention Phase
brca1 Mutation Carrier
brca2 Mutation Carrier
Ovarian Cancer
Drug: celecoxib
Procedure: oophorectomy
Phase II

MedlinePlus related topics: Cancer Ovarian Cancer
Drug Information available for: Celecoxib 4-(5-(4-Methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl)benzenesulfonamide
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention
Official Title: 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

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: June 2002
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.

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 older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00084370

Locations
United States, Alabama
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294-3300
Sponsors and Collaborators
Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham
Investigators
Principal Investigator: Edward E. Partridge, MD Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000352114, UAB-0134
Study First Received: June 10, 2004
Last Updated: August 29, 2008
ClinicalTrials.gov Identifier: NCT00084370  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
ovarian epithelial cancer
BRCA1 mutation carrier
BRCA2 mutation carrier

Study placed in the following topic categories:
Genital Diseases, Female
Ovarian cancer
Celecoxib
Ovarian Neoplasms
Gonadal Disorders
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Endocrinopathy
Ovarian Diseases
Ovarian epithelial cancer
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase Inhibitors
Physiological Effects of Drugs
Enzyme Inhibitors
Pharmacologic Actions
Adnexal Diseases
Neoplasms
Neoplasms by Site
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009