Celecoxib in Treating Women With Metastatic or Recurrent Breast Cancer
- Registration Number
- NCT00045591
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Brief Summary
RATIONALE: Celecoxib may stop the growth of tumor cells by blocking the enzymes necessary for their growth and by stopping blood flow to the tumor. It is not yet known which regimen of celecoxib is more effective in treating breast cancer.
PURPOSE: Randomized phase II trial to compare the effectiveness of two regimens of celecoxib in treating women who have metastatic or recurrent breast cancer
- Detailed Description
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 39
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Celecoxib 100 mg Celecoxib - Celecoxib 400 mg Celecoxib -
- Primary Outcome Measures
Name Time Method Progression free survival 28 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (74)
University of Chicago Cancer Research Center
🇺🇸Chicago, Illinois, United States
Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
Memorial Regional Cancer Center at Memorial Regional Hospital
🇺🇸Hollywood, Florida, United States
Veterans Affairs Medical Center - Chicago (Westside Hospital)
🇺🇸Chicago, Illinois, United States
Fort Wayne Medical Oncology and Hematology, Incorporated
🇺🇸Fort Wayne, Indiana, United States
Veterans Affairs Medical Center - Syracuse
🇺🇸Syracuse, New York, United States
CCOP - Northern Indiana CR Consortium
🇺🇸South Bend, Indiana, United States
North Shore University Hospital
🇺🇸Manhasset, New York, United States
Veterans Affairs Medical Center - Asheville
🇺🇸Asheville, North Carolina, United States
Greenebaum Cancer Center at University of Maryland Medical Center
🇺🇸Baltimore, Maryland, United States
SUNY Upstate Medical University Hospital
🇺🇸Syracuse, New York, United States
Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Lenoir Memorial Cancer Center
🇺🇸Kinston, North Carolina, United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
CCOP - Southern Nevada Cancer Research Foundation
🇺🇸Las Vegas, Nevada, United States
Naval Medical Center - San Diego
🇺🇸San Diego, California, United States
Veterans Affairs Medical Center - San Diego
🇺🇸San Diego, California, United States
Veterans Affairs Medical Center - Minneapolis
🇺🇸Minneapolis, Minnesota, United States
University of Minnesota Cancer Center
🇺🇸Minneapolis, Minnesota, United States
Veterans Affairs Medical Center - Durham
🇺🇸Durham, North Carolina, United States
Duke Comprehensive Cancer Center
🇺🇸Durham, North Carolina, United States
Lombardi Cancer Center at Georgetown University Medical Center
🇺🇸Washington, District of Columbia, United States
Veterans Affairs Medical Center - Buffalo
🇺🇸Buffalo, New York, United States
Veterans Affairs Medical Center - Washington, DC
🇺🇸Washington, District of Columbia, United States
New Hampshire Oncology-Hematology, PA - Hooksett
🇺🇸Hooksett, New Hampshire, United States
Cancer Institute of New Jersey at the Cooper University Hospital
🇺🇸Camden, New Jersey, United States
MBCCOP - University of Illinois at Chicago
🇺🇸Chicago, Illinois, United States
Broward General Medical Center
🇺🇸Fort Lauderdale, Florida, United States
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Rebecca and John Moores UCSD Cancer Center
🇺🇸La Jolla, California, United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
🇺🇸East Syracuse, New York, United States
Veterans Affairs Medical Center - Las Vegas
🇺🇸Las Vegas, Nevada, United States
Queens Cancer Center of Queens Hospital
🇺🇸Jamaica, New York, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
Missouri Baptist Cancer Center
🇺🇸Saint Louis, Missouri, United States
Siteman Cancer Center at Barnes-Jewish Hospital
🇺🇸Saint Louis, Missouri, United States
CCOP - Southeast Cancer Control Consortium
🇺🇸Goldsboro, North Carolina, United States
Northeast Alabama Regional Medical Center
🇺🇸Anniston, Alabama, United States
CCOP - North Shore University Hospital
🇺🇸Manhasset, New York, United States
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States
UCSF Comprehensive Cancer Center
🇺🇸San Francisco, California, United States
Veterans Affairs Medical Center - San Francisco
🇺🇸San Francisco, California, United States
UNMC Eppley Cancer Center at the University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Comprehensive Cancer Center at Wake Forest University
🇺🇸Winston-Salem, North Carolina, United States
Oklahoma University Medical Center
🇺🇸Oklahoma City, Oklahoma, United States
CCOP - Christiana Care Health Services
🇺🇸Newark, Delaware, United States
CCOP - Mount Sinai Medical Center
🇺🇸Miami Beach, Florida, United States
Walter Reed Army Medical Center
🇺🇸Washington, District of Columbia, United States
West Suburban Center for Cancer Care
🇺🇸River Forest, Illinois, United States
Holden Comprehensive Cancer Center at University of Iowa
🇺🇸Iowa City, Iowa, United States
Lagrange Oncology Associates
🇺🇸La Grange, Illinois, United States
CCOP - Illinois Oncology Research Association
🇺🇸Peoria, Illinois, United States
UMASS Memorial Cancer Center - University Campus
🇺🇸Worcester, Massachusetts, United States
Ellis Fischel Cancer Center at University of Missouri - Columbia
🇺🇸Columbia, Missouri, United States
Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph
🇺🇸Saint Joseph, Michigan, United States
Veterans Affairs Medical Center - Columbia (Truman Memorial)
🇺🇸Columbia, Missouri, United States
Elmhurst Hospital Center
🇺🇸Elmhurst, New York, United States
New York Weill Cornell Cancer Center at Cornell University
🇺🇸New York, New York, United States
Mount Sinai Medical Center
🇺🇸New York, New York, United States
Cape Fear Valley Medical Center
🇺🇸Fayetteville, North Carolina, United States
NorthEast Oncology Associates - Concord
🇺🇸Concord, North Carolina, United States
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
🇺🇸Columbus, Ohio, United States
Comprehensive Cancer Center at Moore Regional Hospital
🇺🇸Pinehurst, North Carolina, United States
Zimmer Cancer Center at New Hanover Regional Medical Center
🇺🇸Wilmington, North Carolina, United States
Lifespan: The Miriam Hospital
🇺🇸Providence, Rhode Island, United States
Vermont Cancer Center at University of Vermont
🇺🇸Burlington, Vermont, United States
Virginia Oncology Associates - Norfolk
🇺🇸Norfolk, Virginia, United States
Martha Jefferson Hospital
🇺🇸Charlottesville, Virginia, United States
MBCCOP - Massey Cancer Center
🇺🇸Richmond, Virginia, United States
Oncology and Hematology Associates of Southwest Virginia, Incorporated - Roanoke
🇺🇸Roanoke, Virginia, United States
St. Mary's Medical Center
🇺🇸Huntington, West Virginia, United States
Baptist Hospital East - Louisville
🇺🇸Louisville, Kentucky, United States
CCOP - Kansas City
🇺🇸Kansas City, Missouri, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States