This randomized phase II trial is studying how well celecoxib works in preventing cervical
cancer in patients with CIN. Chemoprevention therapy is the use of certain drugs to try to
prevent the development of cancer or to treat early cancer. Celecoxib may be effective in
preventing the development of cervical cancer in patients who have cervical intraepithelial
neoplasia (CIN).
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
Inclusion Criteria:
- Histologically confirmed cervical intraepithelial neoplasia (CIN) 2/3 or 3 by
cervical biopsy 2-8 weeks prior to study entry
- Pathology report must clearly state "CIN 2/3" or "3" OR "moderate-severe
dysplasia," "moderate-severe dyskaryosis," "severe dysplasia," or "sever
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
- Performance status - GOG 0-2
- Platelet count > 125,000/mm^3
- Hemoglobin > 11. 0 g/dL
- WBC > 3,000/mm^3
- No significant bleeding disorder
- Bilirubin ≤ 1. 5 times upper limit of normal (ULN) (> 1. 5 times ULN allowed if due to
Gilbert's disease)
- AST and ALT < 2. 0 times ULN
- No hepatic disorder
- Creatinine ≤ 1. 5 times ULN
- No known renal failure
- No history of transient ischemic attack or stroke
- No history of cardiovascular disease
- No uncontrolled hypertension
- 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 sulfonamides
- 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
- At least 15 days since prior nonsteriodal anti-inflammatory agents (NSAIDs) or
aspirin
- No other concurrent NSAIDs or aspirin
- No concurrent fluconazole or lithium
Arizona Cancer Center at University Medical Center North, Tucson, Arizona 85719, United States
University of Arkansas for Medical Sciences, Little Rock, Arkansas 72205, United States
Beebe Medical Center, Lewes, Delaware 19958, United States
Christiana Care Health System-Christiana Hospital, Newark, Delaware 19718, United States
Carle Clinic-Urbana Main, Urbana, Illinois 61801, United States
Elkhart Clinic, Elkhart, Indiana 46514-2098, United States
Elkhart General Hospital, Elkhart, Indiana 46515, United States
Michiana Hematology Oncology PC-Elkhart, Elkhart, Indiana 46514, United States
Community Howard Regional Health, Kokomo, Indiana 46904, United States
IU Health La Porte Hospital, La Porte, Indiana 46350, United States
Michiana Hematology Oncology PC-Mishawaka, Mishawaka, Indiana 46545-1470, United States
Saint Joseph Regional Medical Center-Mishawaka, Mishawaka, Indiana 46545-1470, United States
Michiana Hematology Oncology PC-Plymouth, Plymouth, Indiana 46563, United States
Memorial Hospital of South Bend, South Bend, Indiana 46601, United States
Michiana Hematology Oncology PC-South Bend, South Bend, Indiana 46601, United States
Northern Indiana Cancer Research Consortium, South Bend, Indiana 46628, United States
Michiana Hematology Oncology-PC Westville, Westville, Indiana 46391, United States
The James Graham Brown Cancer Center at University of Louisville, Louisville, Kentucky 40202, United States
Union Hospital of Cecil County, Elkton MD, Maryland 21921, United States
Borgess Medical Center, Kalamazoo, Michigan 49001, United States
Bronson Methodist Hospital, Kalamazoo, Michigan 49007, United States
West Michigan Cancer Center, Kalamazoo, Michigan 49007, United States
Marie Yeager Cancer Center, Saint Joseph, Michigan 49085, United States
Lakeland Hospital, St. Joseph, Michigan 49085, United States
University of Missouri - Ellis Fischel, Columbia, Missouri 65212, United States
Saint Louis University Hospital, Saint Louis, Missouri 63110, United States
Washington University School of Medicine, Saint Louis, Missouri 63110, United States
Women's Cancer Center of Nevada, Las Vegas, Nevada 89169, United States
UMDNJ - New Jersey Medical School, Newark, New Jersey 07103, United States
University of New Mexico Cancer Center, Albuquerque, New Mexico 87106, United States
Montefiore Medical Center - Moses Campus, Bronx, New York 10467-2490, United States
University of North Carolina, Chapel Hill, North Carolina 27599, United States
Gynecologic Oncology Network, Greenville, North Carolina 27834, United States
FirstHealth of the Carolinas-Moore Regional Hosiptal, Pinehurst, North Carolina 28374, United States
Wake Forest University Health Sciences, Winston-Salem, North Carolina 27157, United States
University of Cincinnati, Cincinnati, Ohio 45267, United States
Case Western Reserve University, Cleveland, Ohio 44106, United States
Hillcrest Hospital Cancer Center, Mayfield Heights, Ohio 44124, United States
Lake University Ireland Cancer Center, Mentor, Ohio 44060, United States
University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma 73104, United States
Tulsa Cancer Institute, Tulsa, Oklahoma 74146, United States
Sanford USD Medical Center - Sioux Falls, Sioux Falls, South Dakota 57117-5134, United States
Vanderbilt-Ingram Cancer Center, Nashville, Tennessee 37232, United States
Brooke Army Medical Center, Fort Sam Houston, Texas 78234, United States
Carilion Clinic Gynecological Oncology, Roanoke, Virginia 24016, United States
Froedtert and the Medical College of Wisconsin, Milwaukee, Wisconsin 53226, United States