Study of Oxaliplatin/5-FU/Leucovorin Plus Vatalanib Versus Oxaliplatin/5-FU/Leucovorin in Patients With Metastatic Colorectal Cancer.
NCT ID: NCT00056459
Last Updated: 2020-02-10
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
1168 participants
INTERVENTIONAL
2003-02-28
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
* Documented metastatic colorectal cancer
* 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 for metastatic colorectal cancer
* Prior full field radiotherapy within 4 weeks or limited field radiotherapy within 2 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 anti-VEGF agents
* Any prior therapy with oxaliplatin or allergy to platinum-containing drugs
* Peripheral neuropathy with functional impairment
* Female patients who are pregnant or breast feeding
* Any severe or uncontrolled medical conditions which could prevent participation in study
* Patients who are taking Coumadin
18 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Novartis
INDUSTRY
Responsible Party
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Novartis
Principal Investigators
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Novartis / Schering AG, Germany
Role: STUDY_CHAIR
Novartis / Schering AG, Germany
Locations
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Alabama Hematology/Oncology
Birmingham, Alabama, United States
Palo Verde Hematology & Oncology
Glendale, Arizona, United States
Arizona Cancer Center
Tucson, Arizona, United States
Northeast Arkansas Clinic
Jonesboro, 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
Ronald Yanagiharaa, M.D.
Gilroy, California, United States
Glendale Adventist Medical Center Cancer Center
Glendale, California, United States
Pacific Shores Medical Group
Long Beach, California, United States
Cancer Institute Medical Group
Los Angeles, California, United States
USC/Norris Comprehensive Cancer Care Center
Los Angeles, California, United States
Synergy Hematology-Oncology Medical Associates
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
Ventura County Hematology-Oncology Specialists
Oxnard, California, United States
Wilshire Oncology Medical Group
Pomona, California, United States
Sierra View District Hospital
Porterville, California, United States
The Lucy Curci Cancer Center
Rancho Mirage, California, United States
Cancer Care Associates Medical Group, Inc.
Redondo Beach, California, United States
Pacific Hematology Oncology Associates
San Francisco, 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
Colorado Cancer Research Program
Denver, Colorado, United States
Jennifer Caskey, M.D.
Wheat Ridge, Colorado, United States
Davis, Posteraro and Wasser, MD's, LLP
Manchester, Connecticut, United States
Connecticut Oncology Group
Middletown, Connecticut, United States
Medical Oncology Hematology Consultants
Newark, Delaware, United States
Washington Oncology-Hematology Center
Washington D.C., District of Columbia, United States
George Washington University Medical Center
Washington D.C., District of Columbia, United States
Boca Raton Comprehensive Cancer Center
Boca Raton, Florida, United States
Florida Cancer Specialists
Fort Myers, Florida, United States
Memorial Healthcare System
Hollywood, Florida, United States
Florida Oncology Associates
Jacksonville, Florida, United States
Lakeland Regional Cancer Center
Lakeland, Florida, United States
Oncology Hematology Group of South Florida
Miami, Florida, United States
Innovative Medical Research of South Florida
Miami Shores, Florida, United States
Hematology Oncology Associates of Treasure
Port Saint Lucie, Florida, United States
Florida Medical Clinic, PA
Zephyrhills, Florida, United States
Peachtree Hematology and Oncology
Atlanta, Georgia, United States
Coastal Hematology & Oncology
Savannah, Georgia, United States
North Idaho Cancer Center
Coeur d'Alene, Idaho, United States
Shelby D. Rifkin, M.D.
Arlington Heights, Illinois, United States
Monroe Medical Associates
Harvey, 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
Hematology-Oncology of Indiana, PC
Indianapolis, Indiana, United States
Associated Physicians & Surgeons Clinic, L.L.C.
Terre Haute, Indiana, United States
Markey Clinical Oncology Research Program
Lexington, Kentucky, United States
Norton Healthcare Pavilion
Louisville, Kentucky, United States
Vijay Raghavan, M.D.
Louisville, Kentucky, United States
Louisiana Oncology Associates
Lafayette, 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, Inc.
Baltimore, Maryland, United States
Kaiser Permanente
Rockville, Maryland, United States
St. Joseph Mercy Hospital
Ann Arbor, Michigan, United States
Josephine Ford Cancer Center
Detroit, Michigan, United States
Genesys Hurley Cancer Institute
Flint, Michigan, United States
Spectrum Health -- Cook Research Dept.
Grand Rapids, Michigan, United States
Hematology and Oncology Assoc. of Southern Mississippi
Jackson, Michigan, United States
Oncology Care Associates, PLLC
Saint Joseph, Michigan, United States
Providence Cancer Center
Southfield, Michigan, United States
SMDC Health System
Duluth, Minnesota, United States
Minnesota CGOP
Minneapolis, Minnesota, United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States
Metro Minnesota CCOP
Saint Louis Park, Minnesota, United States
Heartland Hematology/Oncology Associates, Inc.
Kansas City, Missouri, United States
Kansas City Oncology and Hematology Group
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
Montana Cancer Specialists
Missoula, Montana, United States
The Methodist Cancer Center
Omaha, Nebraska, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States
Nevada Cancer Center
Las Vegas, Nevada, United States
The 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 New Jersey
Morristown, New Jersey, United States
Southern Oncology and Hematology Associates
Vineland, New Jersey, United States
Cooper Cancer Institute
Voorhees Township, New Jersey, United States
New Mexico Cancer Care
Santa Fe, New Mexico, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
CR Wood Cancer Center
Glens Falls, New York, United States
Cancer Research of Long Island
Great Neck, New York, United States
Broome Oncology
Johnson City, New York, United States
New York Oncology Hematology
Latham, New York, United States
North Shore University Hospital
Manhasset, New York, United States
Cancer Center at Nyack Hospital
Nyack, New York, United States
Pluta Cancer Center
Rochester, New York, United States
Carolina Medical Center
Charlotte, North Carolina, United States
Mid-Dakota Clinic PC
Bismarck, North Dakota, United States
Nashat Gabrail, M.D.
Canton, Ohio, United States
Mid Ohio Oncology/Hematology, Inc.
Columbus, Ohio, United States
Hematology Oncology Consultants, Inc.
Columbus, Ohio, United States
Meridia Cancer Institute
Mayfield Heights, Ohio, United States
Cancer Care Associates
Oklahoma City, Oklahoma, United States
Cancer Care Associates
Tulsa, Oklahoma, United States
Kaiser Permanente Oncology Hematology
Portland, Oregon, United States
Hershey Medical Center
Hershey, Pennsylvania, United States
Monogahela Valley Hospital
Monongahela, Pennsylvania, United States
University of Pennsylvania Abramson Cancer Center
Philadelphia, Pennsylvania, United States
Allegheny Cancer Center
Pittsburgh, Pennsylvania, United States
Charleston Hematology Oncology
Charleston, South Carolina, United States
Charleston Cancer Center
Charleston, South Carolina, United States
South Carolina Oncology Associates
Columbia, South Carolina, United States
Cancer Center of the Carolinas
Greenville, South Carolina, United States
Spartanburg Regional Medical Center
Spartanburg, South Carolina, 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
Southwest Regional Cancer Center
Austin, Texas, United States
Corpus Christi Cancer Center
Corpus Christi, Texas, United States
Center for Oncology Research & Treatment, PA
Dallas, Texas, United States
Oncology Consultants
Houston, Texas, United States
H. Alejandro Preti, MD, PA
Houston, Texas, United States
M.D. Anderson Cancer Center
Houston, Texas, United States
Dr. Lee C. Drinkard
Irving, Texas, United States
Scott & White Hospital
Temple, Texas, United States
North Utah Associates
Ogden, Utah, United States
Utah Cancer Specialists
Salt Lake City, Utah, United States
Southwestern Vermont Health Care
Bennington, Vermont, United States
Danville Hematology and Oncology, Inc.
Danville, Virginia, United States
Northern Virginia Oncology Group
Fairfax, Virginia, United States
Virginia Oncology Associates
Norfolk, Virginia, United States
Cancer Treatment Centers of America
Portsmouth, Virginia, United States
Virginia Cancer Institute
Richmond, Virginia, United States
Western Washington Medical Group
Everett, Washington, United States
Western Washington Medical Group
Everett, Washington, United States
Cascade Cancer Center
Kirkland, Washington, United States
UW Health -- University of Wisconsin Comp
Madison, Wisconsin, United States
Waukesha Memorial Hospital
Waukesha, Wisconsin, United States
Adelaide, , Australia
Garran, , Australia
Nedlands, , Australia
Wollongong, , Australia
Woolloongabba, , Australia
Anderlecht, , Belgium
Antwerp, , Belgium
Brussels, , Belgium
Ghent, , Belgium
Wilrijk, , Belgium
Porto Alegre, , Brazil
Porto Alegre RS, , Brazil
Salvador, , Brazil
São Paulo, , Brazil
São Paulo, , Brazil
São Paulo, , Brazil
Hamilton, Ontario, Canada
Novartis Investigative Site
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Sainte-Foy, Quebec, Canada
Brno, , Czechia
Prague, , Czechia
Prague, , Czechia
Marseille, , France
Marseille, , France
Strasbourg, , France
Augsburg, , Germany
Berlin, , Germany
Berlin, , Germany
Cologne, , Germany
Dessau, , Germany
Erlangen, , Germany
Eschweiler, , Germany
Essen, , Germany
Frankfurt, , Germany
Hanover, , Germany
Heidelberg, , Germany
Kiel, , Germany
Leipzig, , Germany
Magdeburg, , Germany
Budapest, , Hungary
Budapest, , Hungary
Győr, , Hungary
Szeged, , Hungary
Forlì, , Italy
Genova, , Italy
Milan, , Italy
Modena, , Italy
Roma, , Italy
Roma, , Italy
Rozzano, , Italy
Torino, , Italy
GA Utrecht, , Netherlands
Novartis Investigative Site
Hamilton, , New Zealand
Palmerston North, , New Zealand
Coimbra, , Portugal
Novartis Investigative Site
Bratislava, , Slovakia
Novartis Investigative Site
Bratislava, , Slovakia
Novartis Investigative Site
Košice, , Slovakia
Novartis Investigative Site
Žilina, , Slovakia
Alicante, , Spain
Madrid, , Spain
Madrid, , Spain
Madrid, , Spain
Málaga, , Spain
Zaragoza, , Spain
Stockholm, , Sweden
Basel, , Switzerland
Bern, , Switzerland
Thun, , Switzerland
Zurich, , Switzerland
Zurich, , Switzerland
Tainan City, , Taiwan
Taipei, , Taiwan
Taoyuan District, , Taiwan
Belfast, , United Kingdom
Leicester, , United Kingdom
Oxford, , United Kingdom
Countries
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References
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Hecht JR, Trarbach T, Hainsworth JD, Major P, Jager E, Wolff RA, Lloyd-Salvant K, Bodoky G, Pendergrass K, Berg W, Chen BL, Jalava T, Meinhardt G, Laurent D, Lebwohl D, Kerr D. Randomized, placebo-controlled, phase III study of first-line oxaliplatin-based chemotherapy plus PTK787/ZK 222584, an oral vascular endothelial growth factor receptor inhibitor, in patients with metastatic colorectal adenocarcinoma. J Clin Oncol. 2011 May 20;29(15):1997-2003. doi: 10.1200/JCO.2010.29.4496. Epub 2011 Apr 4.
Other Identifiers
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CONFIRM 1
Identifier Type: -
Identifier Source: secondary_id
CPTK787 0135/306241
Identifier Type: -
Identifier Source: org_study_id
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