A Phase I/II Study Of COX-2 Inhibitor, CELEBREX (CELECOXIB), And Chemoradiation In Patients With Locally Advanced Cervical Cancer
OBJECTIVES:
- 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.
Interventional
Primary Purpose: Treatment
David K. Gaffney, MD, PhD
Study Chair
University of Utah
United States: Federal Government
CDR0000068849
NCT00023660
August 2001
Name | Location |
---|---|
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 |