A Phase I/II Study Of COX-2 Inhibitor, CELEBREX (CELECOXIB), And Chemoradiation In Patients With Locally Advanced Cervical Cancer
- Determine treatment-related toxicity rates in patients with locally advanced cervical
cancer treated with external beam radiotherapy and brachytherapy concurrently with
celecoxib, fluorouracil, and cisplatin.
- Determine whether this regimen increases locoregional control rates, distant control,
disease-free survival, and overall survival in these patients.
- Determine whether first-failure patterns in patients treated with this regimen are
changed compared to historical controls.
OUTLINE: This is a multicenter study.
Patients undergo external beam pelvic radiotherapy once daily five days a weeks for 5 weeks
beginning on day 1. Within 8 weeks, patients undergo low-dose or high-dose brachytherapy.
Patients also receive concurrent chemotherapy comprising fluorouracil IV continuously over
days 2-5, 23-26, and 44-47 and cisplatin IV over 4 hours on days 1, 22, and 43. Oral
celecoxib is administered twice daily beginning on day 1 and continuing for 12 months.
Patients are followed every 3 months for 2 years, every 4 months for 1 year, every 6 months
for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 83 patients will be accrued for this study within 1.5 years.
Primary Purpose: Treatment
David K. Gaffney, MD, PhD
University of Utah
United States: Federal Government
|University of Texas - MD Anderson Cancer Center||Houston, Texas 77030-4009|
|State University of New York Health Science Center at Brooklyn||Brooklyn, New York 11203|
|CCOP - Kansas City||Kansas City, Missouri 64131|
|CCOP - Southern Nevada Cancer Research Foundation||Las Vegas, Nevada 89106|
|West Michigan Cancer Center||Kalamazoo, Michigan 49007-3731|
|Comprehensive Cancer Center at Wake Forest University||Winston-Salem, North Carolina 27157-1082|
|Sutter Health Western Division Cancer Research Group||Greenbrae, California 94904|
|Memorial Hospital Cancer Center||Colorado Springs, Colorado 80909|
|Baptist Hospital of Miami||Miami, Florida 33176-2197|
|Methodist Medical Center of Illinois||Peoria, Illinois 61636|
|Newark Beth Israel Medical Center||Newark, New Jersey 07112|
|Community Medical Center||Toms River, New Jersey 08755|
|New York Methodist Hospital||Brooklyn, New York 11215-3609|
|Akron General Medical Center||Akron, Ohio 44302|
|Delaware County Memorial Hospital||Drexel Hill, Pennsylvania 19026|
|Western Pennsylvania Hospital||Pittsburgh, Pennsylvania 15224|
|CCOP - MainLine Health||Wynnewood, Pennsylvania 19096|
|Dixie Regional Medical Center||Saint George, Utah 84770|
|LDS Hospital||Salt Lake City, Utah 84143|
|Kimmel Cancer Center at Thomas Jefferson University - Philadelphia||Philadelphia, Pennsylvania 19107|
|Foundation for Cancer Research and Education||Phoenix, Arizona 85013|
|Monmouth Medical Center||Long Branch, New Jersey 07740-6395|
|South Jersey Regional Cancer Center||Millville, New Jersey 08332|
|UCSF Comprehensive Cancer Center||San Francisco, California 94115|
|Mobile Infirmary Medical Center||Mobile, Alabama 36640-0460|
|Regional Radiation Oncology Center at Rome||Rome, Georgia 30165|
|Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital||Mount Holly, New Jersey 08060|
|Mercy Fitzgerald Hospital||Darby, Pennsylvania 19023|
|Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha||Omaha, Nebraska 68114-4199|
|CCOP - Marshfield Clinic Research Foundation||Marshfield, Wisconsin 54449|
|Paoli Memorial Hospital||Paoli, Pennsylvania 19301-1792|
|Bryn Mawr Hospital||Bryn Mawr, Pennsylvania 19010|
|Lankenau Cancer Center at Lankenau Hospital||Wynnewood, Pennsylvania 19096|
|Mills-Peninsula Health Services||Burlingame, California 94010|
|Ball Memorial Hospital Cancer Center||Muncie, Indiana 47303-3499|
|Akron City Hospital - Summa Health System||Akron, Ohio 44304|