Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

This study has been withdrawn prior to enrollment.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Edward Partridge, University of Alabama at Birmingham Identifier:
First received: June 10, 2004
Last updated: August 21, 2013
Last verified: August 2013

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.

Condition Intervention
brca1 Mutation Carrier
brca2 Mutation Carrier
Ovarian Cancer
Drug: celecoxib
Procedure: oophorectomy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: 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

Resource links provided by NLM:

Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • 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. [ Time Frame: baseline (day of surgery) and 2 years ]

Secondary Outcome Measures:
  • Alteration in gene expression between group I and group II [ Time Frame: from baseline (surgery) to 2 years ]

Enrollment: 0
Study Start Date: June 2002
Study Completion Date: March 2005
Primary Completion Date: March 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1
Group I: Patients receive oral celecoxib twice daily for 3 months and then undergo prophylactic oophorectomy.
Drug: celecoxib
Patients receive ora celecoxib twice daily for 3 months prior to prophylactic oophorectomy.
Procedure: oophorectomy
Experimental: Group II
Group II: Patients undergo immediate prophylactic oophorectomy.
Procedure: oophorectomy

Detailed Description:



  • 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.


  • 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.

Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • 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



  • 19 and over

Performance status

  • GOG 0-1

Life expectancy

  • Not specified


  • 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


  • Transaminases normal
  • Bilirubin normal


  • Creatinine clearance > 80 mL/min OR
  • Creatinine < 2.0 mg/dL


  • No emphysema


  • 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)


Biologic therapy

  • Not specified


  • More than 3 months since prior adjuvant chemotherapy

Endocrine therapy

  • Concurrent adjuvant hormonal therapy (e.g., tamoxifen, leuprolide, or goserelin) allowed


  • More than 3 months since prior adjuvant radiotherapy


  • More than 3 months since prior intraperitoneal surgery (laparoscopy or laparotomy)
  • No prior oophorectomy


  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00084370

United States, Alabama
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294-3300
Sponsors and Collaborators
University of Alabama at Birmingham
National Cancer Institute (NCI)
Principal Investigator: Edward E. Partridge, MD University of Alabama at Birmingham
  More Information

Responsible Party: Edward Partridge, Principal Investigator, University of Alabama at Birmingham Identifier: NCT00084370     History of Changes
Other Study ID Numbers: CDR0000352114
Study First Received: June 10, 2004
Last Updated: August 21, 2013

Keywords provided by University of Alabama at Birmingham:
ovarian epithelial cancer
BRCA1 mutation carrier
BRCA2 mutation carrier

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents processed this record on May 22, 2017