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)
- Determine the efficacy of celecoxib, in terms of achieving histologic complete or
partial response, in patients with cervical intraepithelial neoplasia (CIN) 2/3 or 3.
- Determine the toxicity of this drug in these patients.
- Determine the effect of this drug on changes in lesion size in these patients.
- Determine the effect of this drug on human papillomavirus (HPV) viral load in these
- Correlate histologic response, HPV viral load, lesion size, proliferation index,
apoptosis index, angiogenesis (VEGF) and COX-2 in tissue, amount of VEGF and bFGF in
serum, and serum celecoxib levels during treatment in these patients.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients
are stratified according to lesion size (covering ≤ ½ area of the cervix vs covering > ½
area of the cervix) and degree of cervical intraepithelial neoplasia (CIN) (CIN 2/3 vs CIN
3). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral celecoxib once daily for 14-18 weeks.
- Arm II: Patients receive oral placebo once daily for 14-18 weeks. Patients undergo
colposcopy at week 8 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.
PROJECTED ACCRUAL: A maximum of 130 patients (39 per treatment arm) will be accrued for this
study within 13 months.
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Prevention
Histologic complete response
Janet S. Rader, MD
Washington University Siteman Cancer Center
United States: Food and Drug Administration
|CCOP - Christiana Care Health Services||Wilmington, Delaware 19899|
|Bronson Methodist Hospital||Kalamazoo, Michigan 49007|
|West Michigan Cancer Center||Kalamazoo, Michigan 49007-3731|
|Borgess Medical Center||Kalamazooaa, Michigan 49001|
|Sanford Cancer Center at Sanford USD Medical Center||Sioux Falls, South Dakota 57117-5039|
|Medical College of Wisconsin Cancer Center||Milwaukee, Wisconsin 53226|
|Memorial Hospital of South Bend||South Bend, Indiana 46601|
|CCOP - Northern Indiana CR Consortium||South Bend, Indiana 46601|
|Saint Joseph Regional Medical Center||South Bend, Indiana 46617|
|Charles M. Barrett Cancer Center at University Hospital||Cincinnati, Ohio 45267-0526|
|Arkansas Cancer Research Center at University of Arkansas for Medical Sciences||Little Rock, Arkansas 72205|
|Oklahoma University Cancer Institute||Oklahoma City, Oklahoma 73104|
|Elkhart General Hospital||Elkhart, Indiana 46515|
|Howard Community Hospital||Kokomo, Indiana 46904|
|Lakeland Regional Cancer Care Center - St. Joseph||St. Joseph, Michigan 49085|
|Cancer Care Associates - Saint Francis Campus||Tulsa, Oklahoma 74136-1929|
|Center for Cancer Therapy at LaPorte Hospital and Health Services||La Porte, Indiana 46350|
|Michiana Hematology-Oncology, PC - Elkhart||Elkhart, Indiana 46514|
|Elkhart Clinic, LLC||Elkhart, Indiana 46514-2098|
|Michiana Hematology Oncology PC - La Porte||La Porte, Indiana 46350|
|Michiana Hematology-Oncology, PC - South Bend||Mishawaka, Indiana 46545-1470|
|Michiana Hematology Oncology PC - Plymouth||Plymouth, Indiana 46563|
|Lakeside Cancer Specialists, PLLC||Saint Joseph, Michigan 49085|
|FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center||Pinehurst, North Carolina 28374|
|Women's Cancer Center - La Canada||Las Vegas, Nevada 89169|