S0212 Celecoxib in Treating Patients With High-Grade Squamous Intraepithelial Lesions of the Cervix
NCT ID: NCT00072540
Last Updated: 2013-11-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
Brief Summary
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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
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* 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.
Conditions
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Study Design
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TREATMENT
Interventions
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celecoxib
anti-cytokine therapy
antiangiogenesis therapy
biological therapy
cancer prevention intervention
chemoprevention of cancer
enzyme inhibitor therapy
growth factor antagonist therapy
Eligibility Criteria
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Inclusion Criteria
* 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)
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
SWOG Cancer Research Network
NETWORK
Responsible Party
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Principal Investigators
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William R. Robinson, MD
Role: STUDY_CHAIR
Harrington Cancer Center
Other Identifiers
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S0212
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000340176
Identifier Type: -
Identifier Source: org_study_id