| Trial name or title | GOG 0207: 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 CIN 3) |
| Methods | Randomised, double‐blind, placebo‐controlled, multicenter study. Detail of randomisation unknown |
| Participants | Women age 18 years and over, with histologically proven CIN 2/3 or CIN 3 on cervical biopsy within two‐eight weeks from study entry. Pathology report must clearly state "CIN 2/3" or "3" OR "moderate‐severe dysplasia," "moderate‐severe dyskaryosis," "severe dysplasia," or "severe dyskaryosis." No CIN 2 alone or moderate dysplasia or dyskaryosis alone Colposcopically visible cervical lesion at study entry that is consistent with biopsy. No evidence of endocervical dysplasia or invasive cancer by cytology or biopsy. No history of cervical cancer. Gynecologic Oncology Group performance status 0, 1 or 2. Hematopoietic:platelet count greater than 125,000/mm3, haemoglobin greater than 11.0 g/dL, WBC greater than 3000/mm3. No significant bleeding disorder. Hepatic: bilirubin ≤ 1.5 times ULN (greater than 1.5 times ULN allowed if due to Gilbert's disease), AST and ALT less than 2.0 times ULN, no hepatic disorder. Renal: creatinine ≤ 1.5 times ULN, no known renal failure. Cardiovascular: no history of transient Ischaemic attack or stroke, no history of cardiovascular disease, no uncontrolled hypertension. Other: no undiagnosed abnormal vaginal bleeding, no known immunocompromised condition, no known allergic reaction (such as asthma, urticaria, or other reaction) to NSAIDs or aspirin, no known hypersensitivity to celecoxib,no known allergic reaction to sulphonamides,no history of peptic ulcer disease, must be good candidate for delayed treatment of CIN (i.e. deemed reliable to return for follow‐up and provide adequate contact information), not pregnant or nursing, negative pregnancy test, fertile patients must use effective contraception, no prior renal transplantation. Other: at least 15 days since prior non‐steriodal anti‐inflammatory agents or aspirin, no other concurrent NSAIDs or aspirin, no concurrent fluconazole or lithium. Projected accrual: maximum of 130 patients (39 per treatment arm) |
| Interventions | Arm I: Patients receive oral celecoxib once daily for 14 to 18 weeks. Arm II: Patients receive oral placebo once daily for 14 to 18 weeks. Patients undergo colposcopy at week eight and between weeks 14 and 18. Between weeks 14 and 18, patients with evidence of disease also undergo large loop excision of the transformation zone (cone biopsy) or cervical biopsy and patients with no evidence of disease undergo a cervical biopsy to confirm the absence of disease on colposcopy |
| Outcomes | Primary objectives: 1) to determine the efficacy of celecoxib to induce complete remission or partial regression to CIN 1 of CIN 2/3 or CIN 3 and 2) to determine the toxicity of celecoxib |
| Starting date | Opened October 2005. Closed to accrual April 2012 |
| Contact information | Janet Rader, MD Study Chair |
| User defined 1 | |
| Notes | Data retrieved from clinicaltrials.gov and http://cancer.gov/clinicaltrials/search/view?cdrid=360805&version=healthprofessional |
ALT: alanine aminotransferase AST: aspartate aminotransferase CIN: cervical intraepithelial neoplasia COX: cyclooxygenase NSAID: non‐steroidal anti‐inflammatory agent ULN: upper limit of normal WBC: white blood cells