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

This study has been withdrawn prior to enrollment.
(drug issues)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00072540
First received: November 4, 2003
Last updated: November 7, 2013
Last verified: November 2013

November 4, 2003
November 7, 2013
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Complete list of historical versions of study NCT00072540 on ClinicalTrials.gov Archive Site
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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.

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.

Interventional
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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
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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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
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NCT00072540
CDR0000340176, S0212, U10CA037429
Yes
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