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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00072540
Recruitment Status : Withdrawn (drug issues)
First Posted : November 5, 2003
Last Update Posted : November 8, 2013
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group

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.

Condition or disease Intervention/treatment Phase
Stage 0 Cervical Cancer High-grade Squamous Intraepithelial Lesion Drug: celecoxib Procedure: anti-cytokine therapy Procedure: antiangiogenesis therapy Procedure: biological therapy Procedure: cancer prevention intervention Procedure: chemoprevention of cancer Procedure: enzyme inhibitor therapy Procedure: growth factor antagonist therapy Phase 2

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Primary Purpose: Treatment
Official Title: S0212: Phase IIb Randomized Study of Celecoxib in Patients With High-Grade Squamous Intraepithelial Lesions of the Cervix

Resource links provided by the National Library of Medicine

Drug Information available for: Celecoxib

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over

Performance status

  • Zubrod 0-1

Life expectancy

  • Not specified


  • Not specified


  • SGOT and SGPT less than 2.0 times upper limit of normal (ULN)
  • Bilirubin less than 2.0 times ULN


  • Creatinine less than 2.0 mg/dL


  • 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


  • 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


Biologic therapy

  • Not specified


  • Not specified

Endocrine therapy

  • Not specified


  • No prior pelvic radiotherapy


  • See Disease Characteristics


  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00072540

Sponsors and Collaborators
Southwest Oncology Group
National Cancer Institute (NCI)
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Study Chair: William R. Robinson, MD Harrington Cancer Center

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Responsible Party: Southwest Oncology Group Identifier: NCT00072540     History of Changes
Other Study ID Numbers: CDR0000340176
S0212 ( Other Identifier: SWOG )
U10CA037429 ( U.S. NIH Grant/Contract )
First Posted: November 5, 2003    Key Record Dates
Last Update Posted: November 8, 2013
Last Verified: November 2013

Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Squamous Intraepithelial Lesions of the Cervix
Cervical Intraepithelial Neoplasia
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Uterine Cervical Dysplasia
Precancerous Conditions
Carcinoma in Situ
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Enzyme Inhibitors
Mitosis Modulators
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