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S0212 Celecoxib in Treating Patients With High-Grade Squamous Intraepithelial Lesions of the Cervix

Primary Purpose

Stage 0 Cervical Cancer, High-grade Squamous Intraepithelial Lesion

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
celecoxib
anti-cytokine therapy
antiangiogenesis therapy
biological therapy
cancer prevention intervention
chemoprevention of cancer
enzyme inhibitor therapy
growth factor antagonist therapy
Sponsored by
SWOG Cancer Research Network
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stage 0 Cervical Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically confirmed high-grade squamous intraepithelial lesions (HGSIL) of the cervix Cervical intraepithelial neoplasia (CIN) 2 (moderate dysplasia) OR CIN 3 (severe dysplasia, carcinoma in situ) Must have remaining HGSIL after biopsy No suspicion of invasive cancer by colposcopy within the past 28 days No invasive or preinvasive high-grade intraepithelial neoplasia by endocervical curettage within the past 56 days PATIENT CHARACTERISTICS: Age 18 and over Performance status Zubrod 0-1 Life expectancy Not specified Hematopoietic Not specified Hepatic SGOT and SGPT less than 2.0 times upper limit of normal (ULN) Bilirubin less than 2.0 times ULN Renal Creatinine less than 2.0 mg/dL Immunologic No prior asthma, urticaria, or allergic-type reactions to aspirin or other NSAIDs No allergy to sulfonamides No known sensitivity to celecoxib No known AIDS or HIV-associated complex Other Not pregnant or nursing Fertile patients must use effective contraception No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or adequately treated stage I or II cancer currently in complete remission PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy Not specified Endocrine therapy Not specified Radiotherapy No prior pelvic radiotherapy Surgery See Disease Characteristics Other More than 3 months since prior topical medications for genital condyloma No prior treatment for squamous intraepithelial lesions No concurrent topical medications for genital condyloma No other concurrent treatment No concurrent chronic (daily for more than 30 days) aspirin No other concurrent nonsteroidal anti-inflammatory drugs (NSAIDs)

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    November 4, 2003
    Last Updated
    November 7, 2013
    Sponsor
    SWOG Cancer Research Network
    Collaborators
    National Cancer Institute (NCI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00072540
    Brief Title
    S0212 Celecoxib in Treating Patients With High-Grade Squamous Intraepithelial Lesions of the Cervix
    Official Title
    S0212: Phase IIb Randomized Study of Celecoxib in Patients With High-Grade Squamous Intraepithelial Lesions of the Cervix
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2013
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    drug issues
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    SWOG Cancer Research Network
    Collaborators
    National Cancer Institute (NCI)

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer. Celecoxib may be effective in preventing cervical cancer. PURPOSE: Randomized phase II trial to study the effectiveness of celecoxib in preventing cervical cancer in patients who have high-grade squamous intraepithelial lesions of the cervix.
    Detailed Description
    OBJECTIVES: Compare the complete response rate in patients with high-grade squamous intraepithelial lesions of the cervix treated with celecoxib vs placebo. Compare the toxicity of these drugs in these patients. Determine, preliminarily, the effect of celecoxib on cyclooxygenase-2 expression and human papilloma virus expression in these patients. OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to high-grade squamous intraepithelial lesion status (cervical intraepithelial neoplasia [CIN] 2 vs CIN 3). Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive oral celecoxib twice daily for 1 month. Arm II: Patients receive oral placebo twice daily for 1 month. In both arms, treatment repeats monthly for 3 courses in the absence of disease progression or unacceptable toxicity. All patients then undergo loop electrosurgical excision procedure or cone biopsy to determine response. PROJECTED ACCRUAL: A total of 100 patients (50 per treatment arm) will be accrued for this study within 1-2 years.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stage 0 Cervical Cancer, High-grade Squamous Intraepithelial Lesion

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    celecoxib
    Intervention Type
    Procedure
    Intervention Name(s)
    anti-cytokine therapy
    Intervention Type
    Procedure
    Intervention Name(s)
    antiangiogenesis therapy
    Intervention Type
    Procedure
    Intervention Name(s)
    biological therapy
    Intervention Type
    Procedure
    Intervention Name(s)
    cancer prevention intervention
    Intervention Type
    Procedure
    Intervention Name(s)
    chemoprevention of cancer
    Intervention Type
    Procedure
    Intervention Name(s)
    enzyme inhibitor therapy
    Intervention Type
    Procedure
    Intervention Name(s)
    growth factor antagonist therapy

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    DISEASE CHARACTERISTICS: Histologically confirmed high-grade squamous intraepithelial lesions (HGSIL) of the cervix Cervical intraepithelial neoplasia (CIN) 2 (moderate dysplasia) OR CIN 3 (severe dysplasia, carcinoma in situ) Must have remaining HGSIL after biopsy No suspicion of invasive cancer by colposcopy within the past 28 days No invasive or preinvasive high-grade intraepithelial neoplasia by endocervical curettage within the past 56 days PATIENT CHARACTERISTICS: Age 18 and over Performance status Zubrod 0-1 Life expectancy Not specified Hematopoietic Not specified Hepatic SGOT and SGPT less than 2.0 times upper limit of normal (ULN) Bilirubin less than 2.0 times ULN Renal Creatinine less than 2.0 mg/dL Immunologic No prior asthma, urticaria, or allergic-type reactions to aspirin or other NSAIDs No allergy to sulfonamides No known sensitivity to celecoxib No known AIDS or HIV-associated complex Other Not pregnant or nursing Fertile patients must use effective contraception No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or adequately treated stage I or II cancer currently in complete remission PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy Not specified Endocrine therapy Not specified Radiotherapy No prior pelvic radiotherapy Surgery See Disease Characteristics Other More than 3 months since prior topical medications for genital condyloma No prior treatment for squamous intraepithelial lesions No concurrent topical medications for genital condyloma No other concurrent treatment No concurrent chronic (daily for more than 30 days) aspirin No other concurrent nonsteroidal anti-inflammatory drugs (NSAIDs)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    William R. Robinson, MD
    Organizational Affiliation
    Harrington Cancer Center
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    S0212 Celecoxib in Treating Patients With High-Grade Squamous Intraepithelial Lesions of the Cervix

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