Study of Oxaliplatin/5-FU/Leucovorin Plus Vatalanib Versus Oxaliplatin/5-FU/Leucovorin in Patients With Previously Treated Metastatic Colorectal Cancer
A Randomized, Double-blind, Placebo-controlled, Phase III Study of Oxaliplatin/5-fluorouracil/Leucovorin With PTK787/ZK 222584 or Placebo in Patients With Previously Treated Metastatic Adenocarcinoma of the Colon or Rectum
1 other identifier
interventional
855
17 countries
250
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jan 2003
Typical duration for phase_3
250 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2003
CompletedFirst Submitted
Initial submission to the registry
March 13, 2003
CompletedFirst Posted
Study publicly available on registry
March 14, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2007
CompletedMarch 6, 2017
January 1, 2016
4 years
March 13, 2003
March 2, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall survival
throughout duration of study
Secondary Outcomes (5)
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
Tolerability and safety profile
throughout duration of study
Study Arms (2)
1
EXPERIMENTALOxaliplatin/5-FU/LV and PTK787/ZK 222584
2
PLACEBO COMPARATOROxaliplatin/5-FU/LV and placebo
Interventions
Eligibility Criteria
You may qualify if:
- Confirmed adenocarcinoma of the colon or rectum in patients with metastatic disease
- 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
You may not qualify if:
- History or presence of central nervous system disease
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartis Pharmaceuticalslead
- Bayercollaborator
Study Sites (251)
Comprehensive Cancer Institute
Huntsville, Alabama, 35801, United States
Alaska Oncology and Hematology
Anchorage, Alaska, 99508, United States
Arizona Clinical Research Center
Tucson, Arizona, 85712, United States
Northeast Arkansas Clinic
Jonesboro, Arkansas, 72401, United States
Arkansas Cancer Research Center
Little Rock, Arkansas, 72205, United States
Little Rock Hematology & Oncology
Little Rock, Arkansas, 72205, United States
Highlands Oncology Group
Springdale, Arkansas, 72764, United States
Comprehensive Blood and Cancer Center
Bakersfield, California, 93309, United States
Providence St. Joseph Medical Center
Burbank, California, 91505, United States
Compassionate Cancer Care Medical Group, Inc.
Fountain Valley, California, 92708, United States
California Oncology of the Central Valley
Fresno, California, 93710, United States
Virginia K. Crosson Cancer Center
Fullerton, California, 92835, United States
Glendale Adventist Medical Center
Glendale, California, 91206, United States
Scripps Green Hospital
La Jolla, California, 92037, United States
Wilshire Oncology Medical Group
La Verne, California, 91767, United States
Pacific Shores Medical Group
Long Beach, California, 90813, United States
USC Norris Cancer Center
Los Angeles, California, 90033, United States
Synergy Hematology-Oncology Medical Associates
Los Angeles, California, 90036, United States
Novartis Investigative Site
Los Angeles, California, 90095, United States
UCLA School of Medicine
Los Angeles, California, 90095, United States
Eddie Hong-Lung Hu, M.D.
Monterey Park, California, 91754, United States
North Valley Hematology/Oncology Medical Group
Northridge, California, 91328, United States
Medical Oncology Care Associates
Orange, California, 92868, United States
Ventura County Hematology-Oncology Specialists
Oxnard, California, 93030, United States
Sierra View District Hospital
Porterville, California, 93257, United States
Cancer Care Associates Medical Group, Inc.
Redondo Beach, California, 90277, United States
Santa Clara Valley Medical Center
San Jose, California, 95128, United States
Sansum Santa Barbara Foundation Medical Clinic
Santa Barbara, California, 93105, United States
Santa Barbara Hematology Oncology Medical Group, Inc.
Santa Barbara, California, 93105, United States
San Diego Cancer Center Medical Group
Vista, California, 92083, United States
Mile High Oncology
Denver, Colorado, 80210, United States
Rocky Mountain Cancer Center
Denver, Colorado, 80220, United States
Manchester Hematology/Oncology Assoc.
Manchester, Connecticut, 06040, United States
Washington Oncology/Hematology Center
Washington D.C., District of Columbia, 20037, United States
The Center for Hematology and Oncology
Boca Raton, Florida, 33486, United States
Florida Cancer Specialists
Fort Myers, Florida, 33901, United States
Hematology Oncology Associates
Lake Worth, Florida, 33461-4710, United States
University of Miami School of Medicine
Miami, Florida, 33136, United States
Oncology/Hematology Group of South Florida
Miami, Florida, 33176, United States
Hematology Oncology Associates of Treasure Coast
Port Saint Lucie, Florida, 34952, United States
Florida Medical Clinic
Zephyrhills, Florida, 33542, United States
Atlanta Cancer Care
Marietta, Georgia, 30060, United States
Office of Research
Savannah, Georgia, 31405, United States
Coastal Hematology & Oncology
Savannah, Georgia, 31406, United States
Lewis Hall Singletary Oncology Center
Thomasville, Georgia, 31792, United States
North Idaho Cancer Center
Coeur d'Alene, Idaho, 83814, United States
University of Chicago medical Center, Hematology/Oncology
Chicago, Illinois, 60637, United States
Oncology Hematology Associates of Central Illinois, PC
Peoria, Illinois, 61602, United States
Northshore Cancer Research Association
Skokie, Illinois, 60076, United States
Midwest Cancer Research Group
Skokie, Illinois, 60077, United States
Fort Wayne Medical Oncology & Hematology, Inc.
Fort Wayne, Indiana, 46815, United States
Munster Community Hospital
Munster, Indiana, 46321, United States
Cotton O'Neil Oncology Clinic
Topeka, Kansas, 66606, United States
Vijay Raghaven, M.D.
Louisville, Kentucky, 40215, United States
Owensboro Medical Health System
Owensboro, Kentucky, 42303, United States
Cabrini Center for Cancer Care
Alexandria, Louisiana, 71301, United States
LSU Medical Center
New Orleans, Louisiana, 70112, United States
Tulane University Health Sciences Center
New Orleans, Louisiana, 70112, United States
LSU Health Sciences Center
Shreveport, Louisiana, 71130-3932, United States
Maine Center for Cancer Medicine & Blood Disorders
Scarborough, Maine, 04074, United States
St. Agnes Healthcare
Baltimore, Maryland, 21229-5299, United States
Franklin Square Hospital Center
Baltimore, Maryland, 21237, United States
Kaiser Permanente
Rockville, Maryland, 20850, United States
Fallon Clinic at Worcester Medical Center
Worcester, Massachusetts, 01605, United States
University of Michigan
Ann Arbor, Michigan, 48109-0934, United States
Spectrum Health -- Cook Research Dept.
Grand Rapids, Michigan, 49503, United States
Oncology Care Associates, PLLC
Saint Joseph, Michigan, 49085, United States
Providence Cancer Center
Southfield, Michigan, 48075, United States
Minnesota CGOP
Minneapolis, Minnesota, 55407, United States
Heartland Hematology
Kansas City, Missouri, 64118, United States
Missouri Cancer Care, PC
Saint Charles, Missouri, 63301, United States
Saint Louis University
St Louis, Missouri, 63110, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Missouri Baptist Cancer Center
St Louis, Missouri, 63131, United States
Arch Medical Services Incorporated
St Louis, Missouri, 63141, United States
North Central Montana Professional Building
Great Falls, Montana, 59405, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89109, United States
Nevada Cancer Center
Las Vegas, Nevada, 89109, United States
NH Oncology-Hematology, PA
Hooksett, New Hampshire, 03106, United States
Center for Cancer and Hematologic Disease
Cherry Hill, New Jersey, 08003, United States
St. Barnabas Cancer Center
Livingston, New Jersey, 07039, United States
Hematology Oncology Associates of Northern New Jersey
Morristown, New Jersey, 07960, United States
Cooper Cancer Center
Voorhees Township, New Jersey, 08043, United States
Hematology/Oncology Associates
Albuquerque, New Mexico, 87102, United States
New Mexico Oncology/Hematology
Albuquerque, New Mexico, 87109, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
Hematology/Oncology Associates of Central NY
East Syracuse, New York, 13057, United States
Queens Medical Associates, PC
Fresh Meadows, New York, 11365, United States
Charles R. Wood Cancer Center
Glens Falls, New York, 12801, United States
North Shore University Hospital
Manhasset, New York, 11030, United States
St. Vincent's Catholic Medical Centers of New York
New York, New York, 10011, United States
Hematology-Oncology Associates of Rockland
Nyack, New York, 10956, United States
Pluta Cancer Center
Rochester, New York, 14623, United States
James P. Wilmot Cancer Center
Rochester, New York, 14642, United States
Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599-7305, United States
Carolinas Hematology/Oncology Associates
Charlotte, North Carolina, 28203, United States
Nashat Gabrail, M.D.
Canton, Ohio, 44718, United States
Case Western Reserve University
Cleveland, Ohio, 44106-5056, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Columbus CCOP
Columbus, Ohio, 43206, United States
The University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Oklahoma Oncology, Inc.
Tulsa, Oklahoma, 74104, United States
Consultants in Medical Oncology & Hematology
Drexel Hill, Pennsylvania, 19026, United States
Hematology & Oncology Associates of NE PA
Dunmore, Pennsylvania, 18512, United States
Penn State Hershey Medical Center
Hershey, Pennsylvania, 17033-0850, United States
Monongahela Valley Hospital
Monongahela, Pennsylvania, 15063, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212-4772, United States
UPMC Cancer Pavillion
Pittsburgh, Pennsylvania, 15232, United States
Charleston Cancer Center
Charleston, South Carolina, 29406, United States
South Carolina Oncology Associates
Columbia, South Carolina, 29201, United States
WJB Dom VAMC
Columbia, South Carolina, 29209, United States
Cancer Center of the Carolinas
Greenville, South Carolina, 29615, United States
Spartanburg Regional Medical Center
Spartanburg, South Carolina, 29303, United States
Erlanger Health System
Chattanooga, Tennessee, 37403, United States
Clarksville Regional Hematology/Oncology
Clarksville, Tennessee, 37043, United States
The Jones Clinic
Germantown, Tennessee, 38138, United States
Baptist Regional Cancer Center
Knoxville, Tennessee, 37920, United States
University of Tennessee Cancer Institute
Memphis, Tennessee, 38104, United States
Sarah Cannon Cancer Center
Nashville, Tennessee, 37203, United States
Meharry Medical College
Nashville, Tennessee, 37208, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37212, United States
Vanderbilt University School of Medicine
Nashville, Tennessee, 37232-6307, United States
Harrington Cancer Center
Amarillo, Texas, 79106, United States
Center for Oncology Research & Treatment
Dallas, Texas, 75230, United States
Clinical Hematology & Oncology
Dallas, Texas, 75235, United States
Oncology Consultants
Houston, Texas, 77024, United States
H. Alejandro Preti, M.D., PA
Houston, Texas, 77030, United States
M.D. Anderson Cancer Center
Houston, Texas, 77030, United States
South Texas Oncology & Hematology
San Antonio, Texas, 78207, United States
Scott & White Hospital
Temple, Texas, 76508, United States
Northern Utah Cancer Associates
Ogden, Utah, 84403, United States
Southwestern Vermont Health Care
Bennington, Vermont, 05201, United States
Virginia Oncology Associates
Norfolk, Virginia, 23502, United States
Cancer Treatment Centers of America in Hampton Roads
Portsmouth, Virginia, 23704, United States
Western Washington Clinic
Everett, Washington, 98201, United States
Cascade Cancer Center
Kirkland, Washington, 98034, United States
Rainier Oncology
Puyallup, Washington, 98372, United States
Virginia Mason Medical Center
Seattle, Washington, 98101, United States
Swedish Cancer Institute
Seattle, Washington, 98104, United States
West Virginia University Health Sciences Center
Morgantown, West Virginia, 26506, United States
Waukesha Memorial Hospital
Waukesha, Wisconsin, 53188, United States
Kettle Morain Oncology
West Bend, Wisconsin, 53095, United States
Novartis Investigative Site
Frankston, VIC, Australia
Novartis Investigative Site
Woodville South, SA, Australia
Novartis Investigative Site
Sankt Veit an der Glan, 9300, Austria
Novartis Investigative Site
Antwerp, 2020, Belgium
Novartis Investigative Site
Brasschaat, 2930, Belgium
Novartis Investigative Site
Brussels, 1200, Belgium
Novartis Investigative Site
Leuven, Belgium
Novartis Investigative Site
Liège, 4000, Belgium
Novartis Investigative Site
Wilrijk, 2610, Belgium
Novartis Investigative Site
Porto Alegre RS, CEP 90 610-000, Brazil
Novartis Investigative Site
Salvador - Ba, 41825-010, Brazil
Novartis Investigative Site
Salvador, Bahia, CEP 40170-070, Brazil
Novartis Investigative Site
São Paulo, 01236-000, Brazil
Novartis Investigative Site
São Paulo, 01308-050, Brazil
Novartis Investigative Site
São Paulo, 01406-100, Brazil
Novartis Investigative Site
Calgary, Alberta, T2N4N2, Canada
Novartis Investigative Site
Penticton, British Columbia, V2A3G6, Canada
Novartis Investigative Site
Winnepeg, Manitoba, R2H 2A6, Canada
Novartis Investigative Site
Sydney, Nova Scotia, B1P 1P3, Canada
Novartis Investigative Site
Barrie, Ontario, L4M6M2, Canada
Novartis Investigative Site
Brampton, Ontario, L6W 2Z8, Canada
Novartis Investigative Site
Greater Sudbury, Ontario, P3E 5J1, Canada
Novartis Investigative Site
Hamilton, Ontario, L8V 5C2, Canada
Novartis Investigative Site
Ottawa, Ontario, K1H 1C4, Canada
Novartis Investigative Site
Sainte-Foy, Ontario, G1V 4G5, Canada
Novartis Investigative Site
St. Catharines, Ontario, L2R5K3, Canada
Novartis Investigative Site
Thunder Bay, Ontario, P7A 7T1, Canada
Unknown Facility
Toronto, Ontario, M4C 3E7, Canada
Novartis Investigative Site
Toronto, Ontario, M4N3M5, Canada
Novartis Investigative Site
Toronto, Ontario, M5G1X5, Canada
Novartis Investigative Site
Toronto, Ontario, Canada
Novartis Investigative Site
Windsor, Ontario, N8W 2X3, Canada
Novartis Investigative Site
Greenfield Park, Quebec, J4V2H1, Canada
Novartis Investigative Site
Montreal, Quebec, H2L 4M1, Canada
Novartis Investigative Site
Montreal, Quebec, H2W 1S6, Canada
Novartis Investigative Site
Saskatoon, Saskatchewan, S7N4H4, Canada
Novartis Investigative Site
Avignon, 84000, France
Novartis Investigative Site
Boulogne, 92104, France
Novartis Investigative Site
Lille, 59020, France
Novartis Investigative Site
Marseille, 13385, France
Novartis Investigative Site
Montpellier, 34298, France
Novartis Investigative Site
Nice, 6189, France
Novartis Investigative Site
Rennes, 35042, France
Novartis Investigative Site
Saint-Herblain, 44805, France
Novartis Investigative Site
Strasbourg, 67000, France
Novartis Investigative Site
Toulouse, 31052, France
Novartis Investigative Site
Augsburg, 86150, Germany
Novartis Investigative Site
Berlin, 13585, Germany
Novartis Investigative Site
Berlin, 14195, Germany
Novartis Investigative Site
Bielefeld, 33604, Germany
Novartis Investigative Site
Braunschweig, 38100, Germany
Novartis Investigative Site
Cologne, 50677, Germany
Novartis Investigative Site
Dessau, 6822, Germany
Novartis Investigative Site
Dresden, 1307, Germany
Novartis Investigative Site
Essen, 45122, Germany
Novartis Investigative Site
Essen, 45136, Germany
Novartis Investigative Site
Frankfurt, 60488, Germany
Novartis Investigative Site
Hamburg, 22087, Germany
Novartis Investigative Site
Hanover, 30625, Germany
Novartis Investigative Site
Magdeburg, 39002, Germany
Novartis Investigative Site
München, 81675, Germany
Novartis Investigative Site
Neumünster, 24534, Germany
Novartis Investigative Site
Trier, 54290, Germany
Novartis Investigative Site
Ulm, 89081, Germany
Novartis Investigative Site
Wiesbaden, 65199, Germany
Novartis Investigative Site
Chai Wan, Hong Kong
Novartis Investigative Site
Ancona, 60020, Italy
Novartis Investigative Site
Bergamo, 24128, Italy
Novartis Investigative Site
Brescia, 25124, Italy
Novartis Investigative Site
Cremona, 26100, Italy
Novartis Investigative Site
Genova, 16132, Italy
Novartis Investigative Site
Livorno, 57100, Italy
Novartis Investigative Site
Milan, 20100, Italy
Novartis Investigative Site
Milan, 20141, Italy
Novartis Investigative Site
Reggio Emilia, 42100, Italy
Novartis Investigative Site
Roma, 135, Italy
Novartis Investigative Site
Roma, 149, Italy
Novartis Investigative Site
Rozzano, 20089, Italy
Novartis Investigative Site
Auckland, New Zealand
Novartis Investigative Site
Christchurch, New Zealand
Novartis Investigative Site
Wellington, New Zealand
Novartis Investigative Site
Coimbra, 3000-076, Portugal
Novartis Investigative Site
Lisbon, 1649-035, Portugal
Novartis Investigative Site
Bratislava, 81250, Slovakia
Novartis Investigative Site
Córdoba, 14004, Spain
Novartis Investigative Site
Elche, 3202, Spain
Novartis Investigative Site
Madrid, 28007, Spain
Novartis Investigative Site
Madrid, 28033, Spain
Novartis Investigative Site
Madrid, 28040, Spain
Novartis Investigative Site
Madrid, 8907, Spain
Novartis Investigative Site
Málaga, 29010, Spain
Novartis Investigative Site
Zaragoza, 5009, Spain
Novartis Investigative Site
Gothenburg, SE-416 85, Sweden
Novartis Investigative Site
Stockholm, SE-118 83, Sweden
Novartis Investigative Site
Bern, 3010, Switzerland
Novartis Investigative Site
Thun, 3600, Switzerland
Novartis Investigative Site
Changhua, Taiwan
Novartis Investigative Site
Kaohsiung City, Taiwan
Novartis Investigative Site
Keelung, Taiwan
Novartis Investigative Site
Taichung, Taiwan
Novartis Investigative Site
Tainan, Taiwan
Novartis Investigative Site
Taipei, Taiwan
Novartis Investigative Site
Taoyuan District, Taiwan
Novartis Investigative Site
Belfast, BT9 7AB, United Kingdom
Novartis Investigative Site
Birmingham, B15 2TH, United Kingdom
Novartis Investigative Site
Cardiff, CF147TB, United Kingdom
Novartis Investigative Site
London, W1T 3AA, United Kingdom
Novartis Investigative Site
Manchester, M20 4BX, United Kingdom
Related Publications (1)
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.
PMID: 21464401RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Novartis/Schering AG, Germany
Novartis / Schering AG Germany
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 13, 2003
First Posted
March 14, 2003
Study Start
January 1, 2003
Primary Completion
January 1, 2007
Study Completion
January 1, 2007
Last Updated
March 6, 2017
Record last verified: 2016-01