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)

Fecha de inicio: 1 de junio de 2005

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