Celecoxib in Treating Patients With Cervical Intraepithelial Neoplasia
Cervical Carcinoma, Cervical Intraepithelial Neoplasia Grade 2/3, Stage 0 Cervical Cancer
About this trial
This is an interventional prevention trial for Cervical Carcinoma
Eligibility Criteria
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
Sites / Locations
- University of Arizona Cancer Center-North Campus
- University of Arkansas for Medical Sciences
- Beebe Medical Center
- Christiana Care Health System-Christiana Hospital
- Carle Clinic-Urbana Main
- Elkhart Clinic
- Michiana Hematology Oncology PC-Elkhart
- Elkhart General Hospital
- Community Howard Regional Health
- IU Health La Porte Hospital
- Michiana Hematology Oncology PC-Mishawaka
- Saint Joseph Regional Medical Center-Mishawaka
- Michiana Hematology Oncology PC-Plymouth
- Memorial Hospital of South Bend
- Michiana Hematology Oncology PC-South Bend
- Northern Indiana Cancer Research Consortium
- Michiana Hematology Oncology PC-Westville
- Union Hospital of Cecil County
- Borgess Medical Center
- Bronson Methodist Hospital
- West Michigan Cancer Center
- Lakeland Hospital
- Marie Yeager Cancer Center
- University of Missouri - Ellis Fischel
- Saint Louis University Hospital
- Women's Cancer Center of Nevada
- Rutgers New Jersey Medical School
- Montefiore Medical Center - Moses Campus
- UNC Lineberger Comprehensive Cancer Center
- Gynecologic Oncology Network
- FirstHealth of the Carolinas-Moore Regional Hosiptal
- Wake Forest University Health Sciences
- University of Cincinnati
- Case Western Reserve University
- Hillcrest Hospital Cancer Center
- Lake University Ireland Cancer Center
- University of Oklahoma Health Sciences Center
- Oklahoma Cancer Specialists and Research Institute-Tulsa
- Sanford USD Medical Center - Sioux Falls
- Vanderbilt University/Ingram Cancer Center
- Brooke Army Medical Center
- Carilion Clinic Gynecological Oncology
- Froedtert and the Medical College of Wisconsin
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Arm I (celecoxib)
Arm II (placebo)
Patients receive oral celecoxib once daily for 14-18 weeks.
Patients receive oral placebo once daily for 14-18 weeks.