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Recruitment Status : Withdrawn (drug issues)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

November 4, 2003
November 5, 2003
November 8, 2013
Not Provided
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT00072540 on Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
S0212 Celecoxib in Treating Patients With High-Grade Squamous Intraepithelial Lesions of the Cervix
S0212: Phase IIb Randomized Study of Celecoxib in Patients With High-Grade Squamous Intraepithelial Lesions of the Cervix

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.


  • 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.

Phase 2
Primary Purpose: Treatment
  • 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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Not Provided
Not Provided
Not Provided


  • 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)
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
S0212 ( Other Identifier: SWOG )
U10CA037429 ( U.S. NIH Grant/Contract )
Not Provided
Not Provided
Southwest Oncology Group
Southwest Oncology Group
National Cancer Institute (NCI)
Study Chair: William R. Robinson, MD Harrington Cancer Center
Southwest Oncology Group
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP