Study of Oxaliplatin/5-FU/Leucovorin Plus Vatalanib Versus Oxaliplatin/5-FU/Leucovorin in Patients With Previously Treated Metastatic Colorectal Cancer
NCT ID: NCT00056446
Last Updated: 2017-03-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
855 participants
INTERVENTIONAL
2003-01-31
2007-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
Oxaliplatin/5-FU/LV and PTK787/ZK 222584
Vatalanib
2
Oxaliplatin/5-FU/LV and placebo
Vatalanib
Interventions
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Vatalanib
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* One prior chemotherapy regimen with irinotecan and 5FU
* Evidence of progressive disease within 6 months after last dose of irinotecan
* WHO Performance Status of 0, 1, or 2
* Measurable tumors
* Adequate hematologic status, liver and kidney function
* Life expectancy greater than 12 weeks
* Written informed consent obtained
Exclusion Criteria
* Patients with a history of another primary cancer within 5 years
* Prior chemotherapy within 3 weeks before entry to study
* Major surgery within 4 weeks or minor surgery within 2 weeks before entry to study
* Investigational drugs within 4 weeks before entry to study
* Prior therapy with oxaliplatin
* Peripheral neuropathy with functional impairment
* Female patients who are pregnant or breast feeding
* Any severe or uncontrolled medical condition which could prevent participation in study
* Chronic kidney disease
* Acute or chronic liver disease
* Patients taking Coumadin
18 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis/Schering AG, Germany
Role: STUDY_CHAIR
Novartis / Schering AG Germany
Locations
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Comprehensive Cancer Institute
Huntsville, Alabama, United States
Alaska Oncology and Hematology
Anchorage, Alaska, United States
Arizona Clinical Research Center
Tucson, Arizona, United States
Northeast Arkansas Clinic
Jonesboro, Arkansas, United States
Arkansas Cancer Research Center
Little Rock, Arkansas, United States
Little Rock Hematology & Oncology
Little Rock, Arkansas, United States
Highlands Oncology Group
Springdale, Arkansas, United States
Comprehensive Blood and Cancer Center
Bakersfield, California, United States
Providence St. Joseph Medical Center
Burbank, California, United States
Compassionate Cancer Care Medical Group, Inc.
Fountain Valley, California, United States
California Oncology of the Central Valley
Fresno, California, United States
Virginia K. Crosson Cancer Center
Fullerton, California, United States
Glendale Adventist Medical Center
Glendale, California, United States
Scripps Green Hospital
La Jolla, California, United States
Wilshire Oncology Medical Group
La Verne, California, United States
Pacific Shores Medical Group
Long Beach, California, United States
USC Norris Cancer Center
Los Angeles, California, United States
Synergy Hematology-Oncology Medical Associates
Los Angeles, California, United States
Novartis Investigative Site
Los Angeles, California, United States
UCLA School of Medicine
Los Angeles, California, United States
Eddie Hong-Lung Hu, M.D.
Monterey Park, California, United States
North Valley Hematology/Oncology Medical Group
Northridge, California, United States
Medical Oncology Care Associates
Orange, California, United States
Ventura County Hematology-Oncology Specialists
Oxnard, California, United States
Sierra View District Hospital
Porterville, California, United States
Cancer Care Associates Medical Group, Inc.
Redondo Beach, California, United States
Santa Clara Valley Medical Center
San Jose, California, United States
Sansum Santa Barbara Foundation Medical Clinic
Santa Barbara, California, United States
Santa Barbara Hematology Oncology Medical Group, Inc.
Santa Barbara, California, United States
San Diego Cancer Center Medical Group
Vista, California, United States
Mile High Oncology
Denver, Colorado, United States
Rocky Mountain Cancer Center
Denver, Colorado, United States
Manchester Hematology/Oncology Assoc.
Manchester, Connecticut, United States
Washington Oncology/Hematology Center
Washington D.C., District of Columbia, United States
The Center for Hematology and Oncology
Boca Raton, Florida, United States
Florida Cancer Specialists
Fort Myers, Florida, United States
Hematology Oncology Associates
Lake Worth, Florida, United States
University of Miami School of Medicine
Miami, Florida, United States
Oncology/Hematology Group of South Florida
Miami, Florida, United States
Hematology Oncology Associates of Treasure Coast
Port Saint Lucie, Florida, United States
Florida Medical Clinic
Zephyrhills, Florida, United States
Atlanta Cancer Care
Marietta, Georgia, United States
Office of Research
Savannah, Georgia, United States
Coastal Hematology & Oncology
Savannah, Georgia, United States
Lewis Hall Singletary Oncology Center
Thomasville, Georgia, United States
North Idaho Cancer Center
Coeur d'Alene, Idaho, United States
University of Chicago medical Center, Hematology/Oncology
Chicago, Illinois, United States
Oncology Hematology Associates of Central Illinois, PC
Peoria, Illinois, United States
Northshore Cancer Research Association
Skokie, Illinois, United States
Midwest Cancer Research Group
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
Vijay Raghaven, M.D.
Louisville, Kentucky, United States
Owensboro Medical Health System
Owensboro, Kentucky, United States
Cabrini Center for Cancer Care
Alexandria, Louisiana, United States
LSU Medical Center
New Orleans, Louisiana, United States
Tulane University Health Sciences Center
New Orleans, Louisiana, United States
LSU Health Sciences Center
Shreveport, Louisiana, United States
Maine Center for Cancer Medicine & Blood Disorders
Scarborough, Maine, United States
St. Agnes Healthcare
Baltimore, Maryland, United States
Franklin Square Hospital Center
Baltimore, Maryland, United States
Kaiser Permanente
Rockville, Maryland, United States
Fallon Clinic at Worcester Medical Center
Worcester, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Spectrum Health -- Cook Research Dept.
Grand Rapids, Michigan, United States
Oncology Care Associates, PLLC
Saint Joseph, Michigan, United States
Providence Cancer Center
Southfield, Michigan, United States
Minnesota CGOP
Minneapolis, Minnesota, United States
Heartland Hematology
Kansas City, Missouri, United States
Missouri Cancer Care, PC
Saint Charles, Missouri, United States
Saint Louis University
St Louis, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Missouri Baptist Cancer Center
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
Cooper Cancer Center
Voorhees Township, 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
Hematology/Oncology Associates of Central NY
East Syracuse, New York, United States
Queens Medical Associates, PC
Fresh Meadows, New York, United States
Charles R. Wood Cancer Center
Glens Falls, New York, United States
North Shore University Hospital
Manhasset, 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
Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States
Carolinas Hematology/Oncology Associates
Charlotte, North Carolina, United States
Nashat Gabrail, M.D.
Canton, Ohio, United States
Case Western Reserve University
Cleveland, Ohio, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
Columbus CCOP
Columbus, Ohio, United States
The University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Oklahoma Oncology, Inc.
Tulsa, Oklahoma, United States
Consultants in Medical Oncology & Hematology
Drexel Hill, Pennsylvania, United States
Hematology & Oncology Associates of NE PA
Dunmore, Pennsylvania, United States
Penn State Hershey Medical Center
Hershey, Pennsylvania, United States
Monongahela Valley Hospital
Monongahela, Pennsylvania, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
UPMC Cancer Pavillion
Pittsburgh, Pennsylvania, United States
Charleston Cancer Center
Charleston, South Carolina, United States
South Carolina Oncology Associates
Columbia, South Carolina, United States
WJB Dom VAMC
Columbia, South Carolina, United States
Cancer Center of the Carolinas
Greenville, South Carolina, United States
Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States
Erlanger Health System
Chattanooga, Tennessee, United States
Clarksville Regional Hematology/Oncology
Clarksville, Tennessee, United States
The Jones Clinic
Germantown, Tennessee, United States
Baptist Regional Cancer Center
Knoxville, Tennessee, United States
University of Tennessee Cancer Institute
Memphis, Tennessee, United States
Sarah Cannon Cancer Center
Nashville, Tennessee, United States
Meharry Medical College
Nashville, Tennessee, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Vanderbilt University School of Medicine
Nashville, Tennessee, United States
Harrington Cancer Center
Amarillo, Texas, United States
Center for Oncology Research & Treatment
Dallas, Texas, United States
Clinical Hematology & Oncology
Dallas, Texas, United States
Oncology Consultants
Houston, Texas, United States
H. Alejandro Preti, M.D., PA
Houston, Texas, United States
M.D. Anderson Cancer Center
Houston, Texas, United States
South Texas Oncology & Hematology
San Antonio, Texas, United States
Scott & White Hospital
Temple, Texas, United States
Northern Utah Cancer Associates
Ogden, Utah, United States
Southwestern Vermont Health Care
Bennington, Vermont, United States
Virginia Oncology Associates
Norfolk, Virginia, United States
Cancer Treatment Centers of America in Hampton Roads
Portsmouth, Virginia, United States
Western Washington Clinic
Everett, Washington, United States
Cascade Cancer Center
Kirkland, Washington, United States
Rainier Oncology
Puyallup, Washington, United States
Virginia Mason Medical Center
Seattle, Washington, United States
Swedish Cancer Institute
Seattle, Washington, United States
West Virginia University Health Sciences Center
Morgantown, West Virginia, United States
Waukesha Memorial Hospital
Waukesha, Wisconsin, United States
Kettle Morain Oncology
West Bend, Wisconsin, United States
Novartis Investigative Site
Frankston, , Australia
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Woodville South, , Australia
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Sankt Veit an der Glan, , Austria
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Antwerp, , Belgium
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Brasschaat, , Belgium
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Brussels, , Belgium
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Leuven, , Belgium
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Liège, , Belgium
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Wilrijk, , Belgium
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Porto Alegre RS, , Brazil
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Salvador - Ba, , Brazil
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Salvador, Bahia, , Brazil
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São Paulo, , Brazil
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São Paulo, , Brazil
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São Paulo, , Brazil
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Calgary, Alberta, Canada
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Penticton, British Columbia, Canada
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Winnepeg, Manitoba, Canada
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Sydney, Nova Scotia, Canada
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Barrie, Ontario, Canada
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Brampton, Ontario, Canada
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Greater Sudbury, Ontario, Canada
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Hamilton, Ontario, Canada
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Ottawa, Ontario, Canada
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Sainte-Foy, Ontario, Canada
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St. Catharines, Ontario, Canada
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Thunder Bay, Ontario, Canada
Toronto, Ontario, Canada
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Toronto, Ontario, Canada
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Toronto, Ontario, Canada
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Toronto, Ontario, Canada
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Windsor, Ontario, Canada
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Greenfield Park, Quebec, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Saskatoon, Saskatchewan, Canada
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Avignon, , France
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Boulogne, , France
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Lille, , France
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Marseille, , France
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Montpellier, , France
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Nice, , France
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Rennes, , France
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Saint-Herblain, , France
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Strasbourg, , France
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Toulouse, , France
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Augsburg, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Bielefeld, , Germany
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Braunschweig, , Germany
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Cologne, , Germany
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Dessau, , Germany
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Dresden, , Germany
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Essen, , Germany
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Essen, , Germany
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Frankfurt, , Germany
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Hamburg, , Germany
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Hanover, , Germany
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Magdeburg, , Germany
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München, , Germany
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Neumünster, , Germany
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Trier, , Germany
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Ulm, , Germany
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Wiesbaden, , Germany
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Chai Wan, , Hong Kong
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Ancona, , Italy
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Bergamo, , Italy
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Brescia, , Italy
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Cremona, , Italy
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Genova, , Italy
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Livorno, , Italy
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Milan, , Italy
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Milan, , Italy
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Reggio Emilia, , Italy
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Roma, , Italy
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Roma, , Italy
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Rozzano, , Italy
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Auckland, , New Zealand
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Christchurch, , New Zealand
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Wellington, , New Zealand
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Coimbra, , Portugal
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Lisbon, , Portugal
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Bratislava, , Slovakia
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Córdoba, , Spain
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Elche, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Málaga, , Spain
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Zaragoza, , Spain
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Gothenburg, , Sweden
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Stockholm, , Sweden
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Bern, , Switzerland
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Thun, , Switzerland
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Changhua, , Taiwan
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Kaohsiung City, , Taiwan
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Keelung, , Taiwan
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Taichung, , Taiwan
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Tainan City, , Taiwan
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Taipei, , Taiwan
Novartis Investigative Site
Taoyuan District, , Taiwan
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Belfast, , United Kingdom
Novartis Investigative Site
Birmingham, , United Kingdom
Novartis Investigative Site
Cardiff, , United Kingdom
Novartis Investigative Site
London, , United Kingdom
Novartis Investigative Site
Manchester, , United Kingdom
Countries
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References
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Van Cutsem E, Bajetta E, Valle J, Kohne CH, Hecht JR, Moore M, Germond C, Berg W, Chen BL, Jalava T, Lebwohl D, Meinhardt G, Laurent D, Lin E. Randomized, placebo-controlled, phase III study of oxaliplatin, fluorouracil, and leucovorin with or without PTK787/ZK 222584 in patients with previously treated metastatic colorectal adenocarcinoma. J Clin Oncol. 2011 May 20;29(15):2004-10. doi: 10.1200/JCO.2010.29.5436. Epub 2011 Apr 4.
Other Identifiers
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CPTK787 0133/304946
Identifier Type: -
Identifier Source: org_study_id
NCT00068679
Identifier Type: -
Identifier Source: nct_alias
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