S0212 Celecoxib in Treating Patients With High-Grade Squamous Intraepithelial Lesions of the Cervix (NCT00072540) | Clinical Trial Compass
WithdrawnPhase 2
S0212 Celecoxib in Treating Patients With High-Grade Squamous Intraepithelial Lesions of the Cervix
Stopped: drug issues
0
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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 …