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A Randomized Double-Blind Phase II Trial of Celecoxib, a COX-2 Inhibitor, in the Treatment of Patients With Cervical Intraepithelial Neoplasia 2/3 or 3 (CIN 2/3 or CIN 3)

This study is currently Recruiting

November 2011 By National Cancer Institute (NCI)

First Recieved on April 7, 2004

Last Updated on November 3, 2011

Sponsor: Gynecologic Oncology Group
Collaborators: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
Identifier: NCT00081263

Purpose

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer or to treat early cancer. Celecoxib may be effective in preventing the development of cervical cancer in patients who have cervical intraepithelial neoplasia (CIN). PURPOSE: This randomized phase II trial is studying how well celecoxib works in preventing cervical cancer in patients with CIN.

Study Type: Interventional
Study Design: Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Prevention

Eligibility

Ages Eligible for Study:18 Years
Genders Eligible for Study:Female
Accepts Healthy Volunteers:No
Criteria

DISEASE CHARACTERISTICS: - Histologically confirmed cervical intraepithelial neoplasia (CIN) 2/3 or 3 by cervical biopsy 2-8 weeks prior to study entry - Pathology report must clearly state "CIN 2/3" or "3" OR "moderate-severe dysplasia," "moderate-severe dyskaryosis," "severe dysplasia," or "sever dyskaryosis." - No CIN 2 alone OR moderate dysplasia or dyskaryosis alone - Colposcopically visible cervical lesion at study entry that is consistent with biopsy - No evidence of endocervical dysplasia or invasive cancer by cytology or biopsy - No history of cervical cancer PATIENT CHARACTERISTICS: Age - 18 and over Performance status - GOG 0-2 Life expectancy - Not specified Hematopoietic - Platelet count > 125,000/mm^3 - Hemoglobin > 11.0 g/dL - WBC > 3,000/mm^3 - No significant bleeding disorder Hepatic - Bilirubin ? 1.5 times upper limit of normal (ULN) (> 1.5 times ULN allowed if due to Gilbert's disease) - AST and ALT < 2.0 times ULN - No hepatic disorder Renal - Creatinine ? 1.5 times ULN - No known renal failure Cardiovascular - No history of transient ischemic attack or stroke - No history of cardiovascular disease - No uncontrolled hypertension Other - No undiagnosed abnormal vaginal bleeding - No known immunocompromised condition - No known allergic reaction (such as asthma, urticaria, or other reaction) to NSAIDs or aspirin - No known hypersensitivity to celecoxib - No known allergic reaction to sulfonamides - No history of peptic ulcer disease - Must be good candidate for delayed treatment of CIN (i.e., deemed reliable to return for follow-up and provide adequate contact information) - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - Not specified Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - No prior renal transplantation Other - At least 15 days since prior nonsteriodal anti-inflammatory agents (NSAIDs) or aspirin - No other concurrent NSAIDs or aspirin - No concurrent fluconazole or lithium

Investigators

  • Investigator: Janet S. Rader, MD - Study Chair - Washington University Siteman Cancer Center

Locations

  • Arizona Cancer Center at University Medical Center North

    Tucson, Arizona 85719 United States

  • Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

    Little Rock, Arkansas 72205 United States

  • Tunnell Cancer Center at Beebe Medical Center

    Lewes, Delaware 19958 United States

  • CCOP - Christiana Care Health Services

    Newark, Delaware 19713 United States

  • Union Hospital of Cecil County

    Elkton MD, Maryland 21921 United States

  • Saint Louis University Cancer Center

    Saint Louis, Missouri 63110 United States

  • FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center

    Pinehurst, North Carolina 28374 United States

  • Charles M. Barrett Cancer Center at University Hospital

    Cincinnati, Ohio 45267 United States

  • Oklahoma University Cancer Institute

    Oklahoma City, Oklahoma 73104 United States

  • Cancer Care Associates - Saint Francis Campus

    Tulsa, Oklahoma 74136-1929 United States

  • Sanford Cancer Center at Sanford USD Medical Center

    Sioux Falls, South Dakota 57117-5039 United States

  • Carilion Gynecologic Oncology Associates

    Roanoke, Virginia 24016 United States

  • Medical College of Wisconsin Cancer Center

    Milwaukee, Wisconsin 53226 United States

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