Clinical trial · Interventional
Celecoxib in Treating Patients With Cervical Intraepithelial Neoplasia
A Randomized Double-Blind Phase II Trial of Celecoxib, A COX-2 Inhibitor, in the Treatment of Patients With Cervical Intraepithelial Neoplasia 2/3 or 3 (CIN 2/3 or 3)
NCT00081263CI-TRIAL-00029547completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This randomized phase II trial studies how well celecoxib works in treating patients with cervical intraepithelial neoplasia, a precancerous lesion of the cervix which can develop into cervical cancer. Celecoxib may be effective in preventing the development of cervical cancer in patients who have cervical intraepithelial neoplasia.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Carcinoma | Cervical Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Cervical Intraepithelial Neoplasia Grade 2/3 | Cervical Intraepithelial Neoplasia Grade 2/3 | ONTOLOGY_EXACT | 0.98 |
| Stage 0 Cervical Cancer | Malignant Cervical Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Celecoxib | Drug | Celecoxib | ALIAS |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (celecoxib)
- description
- Patients receive oral celecoxib once daily for 14-18 weeks.
- interventionNames
- Drug: Celecoxib
- Other: Laboratory Biomarker Analysis
- type
- PLACEBO_COMPARATOR
- label
- Arm II (placebo)
- description
- Patients receive oral placebo once daily for 14-18 weeks.
- interventionNames
- Other: Laboratory Biomarker Analysis
- Other: Placebo
Primary outcomes (2)
- measure
- Histologic Regression
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must have histologically proven CIN 2/3 or CIN 3 diagnosed by cervical biopsy between 2 and 8 weeks prior to enrollment * For a patient to be eligible, the pathology report must clearly state "CIN 2/3" or "CIN 3" or must state "moderate-severe dysplasia", "moderate-severe dyskaryosis," "severe dysplasia," or "severe dyskaryosis;" patients with a diagnosis of CIN 2 alone or moderate dysplasia or dyskaryosis alone are not eligible for this study (3/26/2007) * Patients must have a satisfactory (readable, good quality) colposcopic evaluation at least 14 days after diagnostic biopsy * Patients must have signed an approved informed consent and authorization permitting release of personal health information * Patients must have colposcopically visible cervical lesion at entry consistent with biopsy * Patients must have a negative urine pregnancy test; women of childbearing potential must practice an acceptable form of contraception (e.g. intrauterine device, contraceptive pills, diaphragm, condoms) * Patients must have a GOG Performance Status of 0, 1, or 2 * Patients must agree to refrain from using non-steroidal anti-inflammatory drugs (NSAIDS) and aspirin during the time they are taking the study medication * Patients must be good candidates for delayed treatment of their CIN, i.e. they must be reliable to return for follow-up and provide a combination of at least three phone numbers or addresses for contact * Hemoglobin (HgB) greater than 11.0g/dl * White blood cell (WBC) count greater than 3000/mcl * Platelet count greater than 125,000/mcl (3/26/2007) * Creatinine less than or equal to 1.5 x upper limit normal (ULN) * Total bilirubin less than or equal to 1.5 x ULN excluding Gilbert's disease * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 2.0 x ULN Exclusion Criteria: * Patients who are pregnant or lactating * Patients with cytologic or biopsy evidence of endocervical dysplasia or invasive cancer * Patients with undiagnosed abnormal vaginal bleeding * Patients who have previously taken celecoxib or any other COX-2 inhibitor at a frequency of greater than 3 times per week within 2 months (60 days) prior to randomization; patients can use Naproxen without restriction (6/23/2008) * Patients with a known immunocompromised condition * Patients who have had a known allergic reaction to any NSAIDS or aspirin (asthma, urticaria, allergic-type reaction) * Patients with a prior history of cervical cancer * Patients with hypersensitivity to Celecoxib * Patients with a known allergic reaction to sulfonamides * Patients with a history of peptic ulcer disease * Patients currently using fluconazole or lithium * Patients with a chronic or acute renal, or hepatic disorder, a significant bleeding disorder, or any other condition which in the investigator's opinion might preclude study participation for the duration of the trial * Patients with a history of transient ischemic attack (TIA), stroke, cardiovascular disease or uncontrolled hypertension
References
Publications (1)
- DERIVEDRader JS, Sill MW, Beumer JH, Lankes HA, Benbrook DM, Garcia F, Trimble C, Tate Thigpen J, Lieberman R, Zuna RE, Leath CA 3rd, Spirtos NM, Byron J, Thaker PH, Lele S, Alberts D. A stratified randomized double-blind phase II trial of celecoxib for treating patients with cervical intraepithelial neoplasia: The potential predictive value of VEGF serum levels: An NRG Oncology/Gynecologic Oncology Group study. Gynecol Oncol. 2017 May;145(2):291-297. doi: 10.1016/j.ygyno.2017.02.040. Epub 2017 Mar 10. PMID 28285845