ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Celecoxib in Treating Patients With High-Grade Squamous Intraepithelial Lesions of the Cervix

This study has been withdrawn prior to recruitment.

Sponsors and Collaborators: Southwest Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00072540
  Purpose

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 Intervention 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 II

MedlinePlus related topics:   Cancer    Cervical Cancer   

ChemIDplus related topics:   Celecoxib    4-(5-(4-Methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl)benzenesulfonamide   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   Phase IIb Randomized Study of Celecoxib in Patients With High-Grade Squamous Intraepithelial Lesions of the Cervix

Further study details as provided by National Cancer Institute (NCI):

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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)
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00072540

Sponsors and Collaborators
Southwest Oncology Group
National Cancer Institute (NCI)

Investigators
Study Chair:     Charles A. Coltman, MD     San Antonio Cancer Institute    
Investigator:     David S. Alberts, MD     University of Arizona    
Investigator:     William R. Robinson, MD     Harrington Cancer Center    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000340176, SWOG-S0212
First Received:   November 4, 2003
Last Updated:   June 14, 2006
ClinicalTrials.gov Identifier:   NCT00072540
Health Authority:   United States: Federal Government

Study placed in the following topic categories:
Celecoxib
Genital Neoplasms, Female
Uterine Diseases
Urogenital Neoplasms
Cervical Intraepithelial Neoplasia
Carcinoma
Uterine Cervical Neoplasms
Genital Diseases, Female
Uterine Cervical Diseases
Carcinoma in Situ
Cervical intraepithelial neoplasia
Uterine Neoplasms
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase Inhibitors
Physiological Effects of Drugs
Enzyme Inhibitors
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on October 07, 2008




Links to all studies - primarily for crawlers