Study of Oxaliplatin/5-FU/Leucovorin Plus Vatalanib Versus Oxaliplatin/5-FU/Leucovorin in Patients With Previously Treated Metastatic Colorectal Cancer
- Conditions
- Colorectal NeoplasmsRectal NeoplasmsColonic Neoplasms
- Interventions
- Registration Number
- NCT00056446
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
The purpose of this study is to compare treatment with oxaliplatin/5-FU/leucovorin plus vatalanib versus oxaliplatin/5-FU/leucovorin plus placebo in patients with colorectal cancer that has spread to other organs and whose disease has worsened after treatment with irinotecan.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 855
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Vatalanib Oxaliplatin/5-FU/LV and PTK787/ZK 222584 2 Vatalanib Oxaliplatin/5-FU/LV and placebo
- Primary Outcome Measures
Name Time Method Overall survival throughout duration of study
- Secondary Outcome Measures
Name Time Method Tolerability and safety profile throughout duration of study Progression free survival throughout duration of study Time to progression throughout duration of study Time to treatment failure throughout duration of study Tumor response rate throughout duration of study
Trial Locations
- Locations (143)
UCLA School of Medicine
🇺🇸Los Angeles, California, United States
Owensboro Medical Health System
🇺🇸Owensboro, Kentucky, United States
Columbus CCOP
🇺🇸Columbus, Ohio, United States
Thomas Jefferson University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Case Western Reserve University
🇺🇸Cleveland, Ohio, United States
Northeast Arkansas Clinic
🇺🇸Jonesboro, Arkansas, United States
Comprehensive Cancer Institute
🇺🇸Huntsville, Alabama, United States
Highlands Oncology Group
🇺🇸Springdale, Arkansas, United States
Pacific Shores Medical Group
🇺🇸Long Beach, California, United States
Arkansas Cancer Research Center
🇺🇸Little Rock, Arkansas, United States
Little Rock Hematology & Oncology
🇺🇸Little Rock, Arkansas, United States
Ventura County Hematology-Oncology Specialists
🇺🇸Oxnard, California, United States
USC Norris Cancer Center
🇺🇸Los Angeles, California, United States
Synergy Hematology-Oncology Medical Associates
🇺🇸Los Angeles, California, United States
Comprehensive Blood and Cancer Center
🇺🇸Bakersfield, California, United States
Virginia K. Crosson Cancer Center
🇺🇸Fullerton, California, United States
The Center for Hematology and Oncology
🇺🇸Boca Raton, Florida, United States
Scripps Green Hospital
🇺🇸La Jolla, California, United States
North Valley Hematology/Oncology Medical Group
🇺🇸Northridge, California, United States
Sierra View District Hospital
🇺🇸Porterville, California, United States
California Oncology of the Central Valley
🇺🇸Fresno, California, United States
Alaska Oncology and Hematology
🇺🇸Anchorage, Alaska, United States
Wilshire Oncology Medical Group
🇺🇸La Verne, California, United States
Providence St. Joseph Medical Center
🇺🇸Burbank, California, United States
Santa Barbara Hematology Oncology Medical Group, Inc.
🇺🇸Santa Barbara, California, United States
Atlanta Cancer Care
🇺🇸Marietta, Georgia, United States
University of Chicago medical Center, Hematology/Oncology
🇺🇸Chicago, Illinois, United States
Charles R. Wood Cancer Center
🇺🇸Glens Falls, New York, United States
Missouri Baptist Cancer Center
🇺🇸St. Louis, Missouri, United States
Hematology/Oncology Associates of Central NY
🇺🇸East Syracuse, New York, United States
Carolinas Hematology/Oncology Associates
🇺🇸Charlotte, North Carolina, United States
Northern Utah Cancer Associates
🇺🇸Ogden, Utah, United States
West Virginia University Health Sciences Center
🇺🇸Morgantown, West Virginia, United States
Rainier Oncology
🇺🇸Puyallup, Washington, United States
Oncology Consultants
🇺🇸Houston, Texas, United States
South Carolina Oncology Associates
🇺🇸Columbia, South Carolina, United States
Hematology & Oncology Associates of NE PA
🇺🇸Dunmore, Pennsylvania, United States
Monongahela Valley Hospital
🇺🇸Monongahela, Pennsylvania, United States
H. Alejandro Preti, M.D., PA
🇺🇸Houston, Texas, United States
Scott & White Hospital
🇺🇸Temple, Texas, United States
Cancer Treatment Centers of America in Hampton Roads
🇺🇸Portsmouth, Virginia, United States
Virginia Oncology Associates
🇺🇸Norfolk, Virginia, United States
Virginia Mason Medical Center
🇺🇸Seattle, Washington, United States
Harrington Cancer Center
🇺🇸Amarillo, Texas, United States
The University of Oklahoma Health Sciences Center
🇺🇸Oklahoma City, Oklahoma, United States
Sarah Cannon Cancer Center
🇺🇸Nashville, Tennessee, United States
South Texas Oncology & Hematology
🇺🇸San Antonio, Texas, United States
Mile High Oncology
🇺🇸Denver, Colorado, United States
Rocky Mountain Cancer Center
🇺🇸Denver, Colorado, United States
M.D. Anderson Cancer Center
🇺🇸Houston, Texas, United States
Western Washington Clinic
🇺🇸Everett, Washington, United States
Swedish Cancer Institute
🇺🇸Seattle, Washington, United States
Sansum Santa Barbara Foundation Medical Clinic
🇺🇸Santa Barbara, California, United States
San Diego Cancer Center Medical Group
🇺🇸Vista, California, United States
Midwest Cancer Research Group
🇺🇸Skokie, Illinois, United States
Compassionate Cancer Care Medical Group, Inc.
🇺🇸Fountain Valley, California, United States
Arizona Clinical Research Center
🇺🇸Tucson, Arizona, United States
Eddie Hong-Lung Hu, M.D.
🇺🇸Monterey Park, California, United States
Novartis Investigative Site
🇬🇧Manchester, United Kingdom
Medical Oncology Care Associates
🇺🇸Orange, California, United States
Cancer Care Associates Medical Group, Inc.
🇺🇸Redondo Beach, California, United States
Manchester Hematology/Oncology Assoc.
🇺🇸Manchester, Connecticut, United States
Florida Cancer Specialists
🇺🇸Ft. Myers, Florida, United States
Hematology Oncology Associates
🇺🇸Lake Worth, Florida, United States
Oncology/Hematology Group of South Florida
🇺🇸Miami, Florida, United States
Hematology Oncology Associates of Treasure Coast
🇺🇸Port St. Lucie, Florida, United States
Florida Medical Clinic
🇺🇸Zephyrhills, Florida, United States
Coastal Hematology & Oncology
🇺🇸Savannah, Georgia, United States
Office of Research
🇺🇸Savannah, Georgia, United States
Lewis Hall Singletary Oncology Center
🇺🇸Thomasville, Georgia, United States
Oncology Hematology Associates of Central Illinois, PC
🇺🇸Peoria, Illinois, United States
Northshore Cancer Research Association
🇺🇸Skokie, Illinois, United States
Fort Wayne Medical Oncology & Hematology, Inc.
🇺🇸Fort Wayne, Indiana, United States
Munster Community Hospital
🇺🇸Munster, Indiana, United States
Cotton O'Neil Oncology Clinic
🇺🇸Topeka, Kansas, United States
Cabrini Center for Cancer Care
🇺🇸Alexandria, Louisiana, United States
LSU Health Sciences Center
🇺🇸Shreveport, Louisiana, United States
St. Agnes Healthcare
🇺🇸Baltimore, Maryland, United States
Maine Center for Cancer Medicine & Blood Disorders
🇺🇸Scarborough, Maine, United States
Kaiser Permanente
🇺🇸Rockville, Maryland, United States
Fallon Clinic at Worcester Medical Center
🇺🇸Worcester, Massachusetts, United States
Franklin Square Hospital Center
🇺🇸Baltimore, Maryland, United States
Spectrum Health -- Cook Research Dept.
🇺🇸Grand Rapids, Michigan, United States
Providence Cancer Center
🇺🇸Southfield, Michigan, United States
Oncology Care Associates, PLLC
🇺🇸St. Joseph, Michigan, United States
Minnesota CGOP
🇺🇸Minneapolis, Minnesota, United States
Saint Louis University
🇺🇸St. Louis, Missouri, United States
Missouri Cancer Care, PC
🇺🇸St. Charles, Missouri, United States
Washington University School of Medicine
🇺🇸St. Louis, Missouri, United States
Arch Medical Services Incorporated
🇺🇸St. Louis, Missouri, United States
North Central Montana Professional Building
🇺🇸Great Falls, Montana, United States
Comprehensive Cancer Centers of Nevada
🇺🇸Las Vegas, Nevada, United States
Nevada Cancer Center
🇺🇸Las Vegas, Nevada, United States
NH Oncology-Hematology, PA
🇺🇸Hooksett, New Hampshire, United States
Center for Cancer and Hematologic Disease
🇺🇸Cherry Hill, New Jersey, United States
St. Barnabas Cancer Center
🇺🇸Livingston, New Jersey, United States
Hematology Oncology Associates of Northern New Jersey
🇺🇸Morristown, New Jersey, United States
Hematology/Oncology Associates
🇺🇸Albuquerque, New Mexico, United States
New Mexico Oncology/Hematology
🇺🇸Albuquerque, New Mexico, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
Queens Medical Associates, PC
🇺🇸Fresh Meadows, New York, United States
St. Vincent's Catholic Medical Centers of New York
🇺🇸New York, New York, United States
Hematology-Oncology Associates of Rockland
🇺🇸Nyack, New York, United States
Pluta Cancer Center
🇺🇸Rochester, New York, United States
James P. Wilmot Cancer Center
🇺🇸Rochester, New York, United States
The Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Nashat Gabrail, M.D.
🇺🇸Canton, Ohio, United States
Oklahoma Oncology, Inc.
🇺🇸Tulsa, Oklahoma, United States
Consultants in Medical Oncology & Hematology
🇺🇸Drexel Hill, Pennsylvania, United States
Penn State Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Allegheny General Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
UPMC Cancer Pavillion
🇺🇸Pittsburgh, Pennsylvania, United States
Cancer Center of the Carolinas
🇺🇸Greenville, South Carolina, United States
Clarksville Regional Hematology/Oncology
🇺🇸Clarksville, Tennessee, United States
Erlanger Health System
🇺🇸Chattanooga, Tennessee, United States
University of Tennessee Cancer Institute
🇺🇸Memphis, Tennessee, United States
Vanderbilt University School of Medicine
🇺🇸Nashville, Tennessee, United States
Center for Oncology Research & Treatment
🇺🇸Dallas, Texas, United States
Clinical Hematology & Oncology
🇺🇸Dallas, Texas, United States
University of Miami School of Medicine
🇺🇸Miami, Florida, United States
Spartanburg Regional Medical Center
🇺🇸Spartanburg, South Carolina, United States
Waukesha Memorial Hospital
🇺🇸Waukesha, Wisconsin, United States
North Idaho Cancer Center
🇺🇸Coeur d'Alene, Idaho, United States
Washington Oncology/Hematology Center
🇺🇸Washington, District of Columbia, United States
Cooper Cancer Center
🇺🇸Voorhees, New Jersey, United States
North Shore University Hospital
🇺🇸Manhasset, New York, United States
Meharry Medical College
🇺🇸Nashville, Tennessee, United States
Vanderbilt-Ingram Cancer Center
🇺🇸Nashville, Tennessee, United States
WJB Dom VAMC
🇺🇸Columbia, South Carolina, United States
Baptist Regional Cancer Center
🇺🇸Knoxville, Tennessee, United States
The Jones Clinic
🇺🇸Germantown, Tennessee, United States
Southwestern Vermont Health Care
🇺🇸Bennington, Vermont, United States
Kettle Morain Oncology
🇺🇸West Bend, Wisconsin, United States
LSU Medical Center
🇺🇸New Orleans, Louisiana, United States
Vijay Raghaven, M.D.
🇺🇸Louisville, Kentucky, United States
Heartland Hematology
🇺🇸Kansas City, Missouri, United States
Tulane University Health Sciences Center
🇺🇸New Orleans, Louisiana, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Lineberger Comprehensive Cancer Center
🇺🇸Chapel Hill, North Carolina, United States
Charleston Cancer Center
🇺🇸Charleston, South Carolina, United States
Santa Clara Valley Medical Center
🇺🇸San Jose, California, United States
Cascade Cancer Center
🇺🇸Kirkland, Washington, United States
Glendale Adventist Medical Center
🇺🇸Glendale, California, United States