Clinical trial · Interventional
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
NCT00072540CI-TRIAL-00012611withdrawnPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): drug issues
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| High-grade Squamous Intraepithelial Lesion | High Grade Squamous Intraepithelial Neoplasia | ALIAS | 0.90 |
| Stage 0 Cervical Cancer | Malignant Cervical Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| antiangiogenesis therapy | Procedure | — | UNRESOLVED |
| anti-cytokine therapy | Procedure | — | UNRESOLVED |
| biological therapy | Procedure | — | UNRESOLVED |
| cancer prevention intervention | Procedure | — | UNRESOLVED |
| celecoxib | Drug | Celecoxib | ALIAS |
| chemoprevention of cancer | Procedure | — | UNRESOLVED |
| enzyme inhibitor therapy | Procedure | — | UNRESOLVED |
| growth factor antagonist therapy | Procedure | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available
No reference posted for this study.