Status:
WITHDRAWN
S0212 Celecoxib in Treating Patients With High-Grade Squamous Intraepithelial Lesions of the Cervix
Lead Sponsor:
SWOG Cancer Research Network
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Stage 0 Cervical Cancer
High-grade Squamous Intraepithelial Lesion
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 tria...
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...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00072540
Last Update
November 8 2013
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