Evaluation Of Novel Therapeutic Agents (Celecoxib: NSC # 719627) Against Breast Cancer: An Innovative Randomized Phase II Trial Design
OBJECTIVES:
Primary
- Compare the progression-free survival of women with metastatic or recurrent breast
cancer treated with 2 dose levels of celecoxib.
Secondary
- Compare the side effects of the 2 dose levels of this drug in these patients.
- Compare the overall survival of patients treated with the 2 dose levels of this drug.
OUTLINE: This is a randomized, double-blind, multicenter study. Patients are stratified
according to disease status at study entry (complete response vs partial response vs stable)
and prior metastatic/recurrent chemotherapy regimens (1 vs 2). Patients are randomized to 1
of 2 treatment arms.
- Arm I: Patients receive oral high-dose celecoxib twice daily.
- Arm II: Patients receive oral low-dose celecoxib twice daily. In both arms, treatment
continues until first disease progression. At disease progression, treatment assignment
is unblinded and treatment may continue at the treating physician's discretion.
Patients initially randomized to the low-dose arm may either continue on that dosage or
crossover to the high-dose arm. Patients initially randomized to the high-dose arm may
continue on that dosage. Treatment after disease progression may continue for up to 12
months.
Patients are followed every 3 months for 1 year and then every 6 months for up to 4 years.
PROJECTED ACCRUAL: A total of 132 patients (88 in the high-dose arm and 44 in the low-dose
arm) will be accrued for this study within 22 months.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Progression free survival
28 months
No
Charles L. Shapiro, MD
Study Chair
Ohio State University Comprehensive Cancer Center
United States: Federal Government
CDR0000256905
NCT00045591
February 2003
Name | Location |
---|---|
Roswell Park Cancer Institute | Buffalo, New York 14263 |
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
Walter Reed Army Medical Center | Washington, District of Columbia 20307-5000 |
University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
University of Minnesota Cancer Center | Minneapolis, Minnesota 55455 |
Duke Comprehensive Cancer Center | Durham, North Carolina 27710 |
CCOP - Kansas City | Kansas City, Missouri 64131 |
CCOP - Southern Nevada Cancer Research Foundation | Las Vegas, Nevada 89106 |
CCOP - Christiana Care Health Services | Wilmington, Delaware 19899 |
CCOP - Mount Sinai Medical Center | Miami Beach, Florida 33140 |
CCOP - North Shore University Hospital | Manhasset, New York 11030 |
CCOP - Southeast Cancer Control Consortium | Winston-Salem, North Carolina 27104-4241 |
MBCCOP - Massey Cancer Center | Richmond, Virginia 23298-0037 |
CCOP - Illinois Oncology Research Association | Peoria, Illinois 61602 |
Comprehensive Cancer Center at Wake Forest University | Winston-Salem, North Carolina 27157-1082 |
Martha Jefferson Hospital | Charlottesville, Virginia 22901 |
MBCCOP - University of Illinois at Chicago | Chicago, Illinois 60612 |
CCOP - Northern Indiana CR Consortium | South Bend, Indiana 46601 |
Holden Comprehensive Cancer Center at University of Iowa | Iowa City, Iowa 52242-1002 |
UMASS Memorial Cancer Center - University Campus | Worcester, Massachusetts 01605-2982 |
Ellis Fischel Cancer Center at University of Missouri - Columbia | Columbia, Missouri 65203 |
Siteman Cancer Center at Barnes-Jewish Hospital | Saint Louis, Missouri 63110 |
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | Lebanon, New Hampshire 03756-0002 |
Cancer Institute of New Jersey at the Cooper University Hospital | Camden, New Jersey 08103-1489 |
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Chapel Hill, North Carolina 27599-7570 |
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University | Columbus, Ohio 43210-1240 |
North Shore University Hospital | Manhasset, New York 11030 |
Veterans Affairs Medical Center - Chicago (Westside Hospital) | Chicago, Illinois 60612 |
Naval Medical Center - San Diego | San Diego, California 92134-3202 |
Veterans Affairs Medical Center - San Francisco | San Francisco, California 94121 |
Baptist Hospital East - Louisville | Louisville, Kentucky 40207 |
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. | Syracuse, New York 13217 |
Veterans Affairs Medical Center - Minneapolis | Minneapolis, Minnesota 55417 |
Veterans Affairs Medical Center - Columbia (Truman Memorial) | Columbia, Missouri 65201 |
Veterans Affairs Medical Center - Buffalo | Buffalo, New York 14215 |
Veterans Affairs Medical Center - Syracuse | Syracuse, New York 13210 |
Veterans Affairs Medical Center - Durham | Durham, North Carolina 27705 |
Rebecca and John Moores UCSD Cancer Center | La Jolla, California 92093-0658 |
Broward General Medical Center | Fort Lauderdale, Florida 33316 |
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | Boston, Massachusetts 02115 |
Northeast Alabama Regional Medical Center | Anniston, Alabama 36207 |
Veterans Affairs Medical Center - San Diego | San Diego, California 92161 |
UCSF Comprehensive Cancer Center | San Francisco, California 94115 |
Veterans Affairs Medical Center - Washington, DC | Washington, District of Columbia 20422 |
West Suburban Center for Cancer Care | River Forest, Illinois 60305 |
Fort Wayne Medical Oncology and Hematology, Incorporated | Fort Wayne, Indiana 46885-5099 |
Veterans Affairs Medical Center - Las Vegas | Las Vegas, Nevada 89106 |
Elmhurst Hospital Center | Elmhurst, New York 11373 |
Queens Cancer Center of Queens Hospital | Jamaica, New York 11432 |
Veterans Affairs Medical Center - Asheville | Asheville, North Carolina 28805 |
Lifespan: The Miriam Hospital | Providence, Rhode Island 02906 |
Virginia Oncology Associates - Norfolk | Norfolk, Virginia 23502 |
St. Mary's Medical Center | Huntington, West Virginia 25701 |
Oklahoma University Medical Center | Oklahoma City, Oklahoma 73104 |
Mount Sinai Medical Center | New York, New York 10029 |
SUNY Upstate Medical University Hospital | Syracuse, New York 13210 |
Vermont Cancer Center at University of Vermont | Burlington, Vermont 05405-0075 |
Lombardi Cancer Center at Georgetown University Medical Center | Washington, District of Columbia 20007 |
Greenebaum Cancer Center at University of Maryland Medical Center | Baltimore, Maryland 21201 |
UNMC Eppley Cancer Center at the University of Nebraska Medical Center | Omaha, Nebraska 68198-7680 |
New Hampshire Oncology-Hematology, PA - Hooksett | Hooksett, New Hampshire 03106 |
NorthEast Oncology Associates - Concord | Concord, North Carolina 28025 |
Oncology and Hematology Associates of Southwest Virginia, Incorporated - Roanoke | Roanoke, Virginia 24014 |
Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph | Saint Joseph, Michigan 49085 |
New York Weill Cornell Cancer Center at Cornell University | New York, New York 10021 |
Cape Fear Valley Medical Center | Fayetteville, North Carolina 28302-2000 |
Lenoir Memorial Cancer Center | Kinston, North Carolina 28503-1678 |
Comprehensive Cancer Center at Moore Regional Hospital | Pinehurst, North Carolina 28374 |
Zimmer Cancer Center at New Hanover Regional Medical Center | Wilmington, North Carolina 28402-9025 |
Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center | Los Angeles, California 90048 |
Memorial Regional Cancer Center at Memorial Regional Hospital | Hollywood, Florida 33021 |
Missouri Baptist Cancer Center | St. Louis, Missouri 63131 |
Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital | Pittsburgh, Pennsylvania 15224-1791 |
Lagrange Oncology Associates | La Grange, Illinois 60525 |