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

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Neoplasms; Rectal Neoplasms; Colonic Neoplasms
• Intervention / Treatment: Drug: Vatalanib

• Study Type: Interventional
• Enrollment (Actual): 855
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • Frankston, Australia, VIC
    • Novartis Investigative Site
  • Woodville South, Australia, SA
    • Novartis Investigative Site
• Austria
  • St. Veit an der Glan, Austria, 9300
    • Novartis Investigative Site
• Belgium
  • Antwerpen, Belgium, 2020
    • Novartis Investigative Site
  • Brasschaat, Belgium, 2930
    • Novartis Investigative Site
  • Bruxelles, Belgium, 1200
    • Novartis Investigative Site
  • Leuven, Belgium
    • Novartis Investigative Site
  • Liège, Belgium, 4000
    • Novartis Investigative Site
  • Wilrijk, Belgium, 2610
    • Novartis Investigative Site
• Brazil
  • Porto Alegre RS, Brazil, CEP 90 610-000
    • Novartis Investigative Site
  • Salvador - Ba, Brazil, 41825-010
    • Novartis Investigative Site
  • Salvador, Bahia, Brazil, CEP 40170-070
    • Novartis Investigative Site
  • Sao Paulo, Brazil, 01236-000
    • Novartis Investigative Site
  • Sao Paulo, Brazil, 01308-050
    • Novartis Investigative Site
  • Sao Paulo, Brazil, 01406-100
    • Novartis Investigative Site
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N4N2
      • Novartis Investigative Site
  • British Columbia
    • Penticton, British Columbia, Canada, V2A3G6
      • Novartis Investigative Site
  • Manitoba
    • Winnepeg, Manitoba, Canada, R2H 2A6
      • Novartis Investigative Site
  • Nova Scotia
    • Sydney, Nova Scotia, Canada, B1P 1P3
      • Novartis Investigative Site
  • Ontario
    • Barrie, Ontario, Canada, L4M6M2
      • Novartis Investigative Site
    • Brampton, Ontario, Canada, L6W 2Z8
      • Novartis Investigative Site
    • Hamilton, Ontario, Canada, L8V 5C2
      • Novartis Investigative Site
    • Ottawa, Ontario, Canada, K1H 1C4
      • Novartis Investigative Site
    • Sainte-Foy, Ontario, Canada, G1V 4G5
      • Novartis Investigative Site
    • St. Catharines, Ontario, Canada, L2R5K3
      • Novartis Investigative Site
    • Sudbury, Ontario, Canada, P3E 5J1
      • Novartis Investigative Site
    • Thunder Bay, Ontario, Canada, P7A 7T1
      • Novartis Investigative Site
    • Toronto, Ontario, Canada
      • Novartis Investigative Site
    • Toronto, Ontario, Canada, M5G1X5
      • Novartis Investigative Site
    • Toronto, Ontario, Canada, M4C 3E7
    • Toronto, Ontario, Canada, M4N3M5
      • Novartis Investigative Site
    • Windsor, Ontario, Canada, N8W 2X3
      • Novartis Investigative Site
  • Quebec
    • Greenfield Park, Quebec, Canada, J4V2H1
      • Novartis Investigative Site
    • Montreal, Quebec, Canada, H2W 1S6
      • Novartis Investigative Site
    • Montreal, Quebec, Canada, H2L 4M1
      • Novartis Investigative Site
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7N4H4
      • Novartis Investigative Site
• France
  • Avignon, France, 84000
    • Novartis Investigative Site
  • Boulogne Cedex, France, 92104
    • Novartis Investigative Site
  • Lille cedex, France, 59020
    • Novartis Investigative Site
  • Marseille cedex 05, France, 13385
    • Novartis Investigative Site
  • Montpellier cedex 5, France, 34298
    • Novartis Investigative Site
  • Nice cedex 2, France, 6189
    • Novartis Investigative Site
  • Rennes cedex, France, 35042
    • Novartis Investigative Site
  • Saint Herblain, France, 44805
    • Novartis Investigative Site
  • Strasbourg, France, 67000
    • Novartis Investigative Site
  • Toulouse cedex, France, 31052
    • Novartis Investigative Site
• Germany
  • Augsburg, Germany, 86150
    • Novartis Investigative Site
  • Berlin, Germany, 13585
    • Novartis Investigative Site
  • Berlin, Germany, 14195
    • Novartis Investigative Site
  • Bielefeld, Germany, 33604
    • Novartis Investigative Site
  • Braunschweig, Germany, 38100
    • Novartis Investigative Site
  • Dessau, Germany, 6822
    • Novartis Investigative Site
  • Dresden, Germany, 1307
    • Novartis Investigative Site
  • Essen, Germany, 45122
    • Novartis Investigative Site
  • Essen, Germany, 45136
    • Novartis Investigative Site
  • Frankfurt, Germany, 60488
    • Novartis Investigative Site
  • Hamburg, Germany, 22087
    • Novartis Investigative Site
  • Hannover, Germany, 30625
    • Novartis Investigative Site
  • Köln, Germany, 50677
    • Novartis Investigative Site
  • Magdeburg, Germany, 39002
    • Novartis Investigative Site
  • München, Germany, 81675
    • Novartis Investigative Site
  • Neumünster, Germany, 24534
    • Novartis Investigative Site
  • Trier, Germany, 54290
    • Novartis Investigative Site
  • Ulm, Germany, 89081
    • Novartis Investigative Site
  • Wiesbaden, Germany, 65199
    • Novartis Investigative Site
• Hong Kong
  • ChaiWan, Hong Kong
    • Novartis Investigative Site
• Italy
  • Ancona, Italy, 60020
    • Novartis Investigative Site
  • Bergamo, Italy, 24128
    • Novartis Investigative Site
  • Brescia, Italy, 25124
    • Novartis Investigative Site
  • Cremona, Italy, 26100
    • Novartis Investigative Site
  • Genova, Italy, 16132
    • Novartis Investigative Site
  • Livorno, Italy, 57100
    • Novartis Investigative Site
  • Milano, Italy, 20100
    • Novartis Investigative Site
  • Milano, Italy, 20141
    • Novartis Investigative Site
  • Reggio Emilia, Italy, 42100
    • Novartis Investigative Site
  • Roma, Italy, 135
    • Novartis Investigative Site
  • Roma, Italy, 149
    • Novartis Investigative Site
  • Rozzano, Italy, 20089
    • Novartis Investigative Site
• New Zealand
  • Auckland, New Zealand
    • Novartis Investigative Site
  • Christchurch, New Zealand
    • Novartis Investigative Site
  • Wellington, New Zealand
    • Novartis Investigative Site
• Portugal
  • Coimbra, Portugal, 3000-076
    • Novartis Investigative Site
  • Lisboa, Portugal, 1649-035
    • Novartis Investigative Site
• Slovakia
  • Bratislava, Slovakia, 81250
    • Novartis Investigative Site
• Spain
  • Cordoba, Spain, 14004
    • Novartis Investigative Site
  • Elche, Spain, 3202
    • Novartis Investigative Site
  • Madrid, Spain, 28007
    • Novartis Investigative Site
  • Madrid, Spain, 28033
    • Novartis Investigative Site
  • Madrid, Spain, 28040
    • Novartis Investigative Site
  • Madrid, Spain, 8907
    • Novartis Investigative Site
  • Malaga, Spain, 29010
    • Novartis Investigative Site
  • Zaragoza, Spain, 5009
    • Novartis Investigative Site
• Sweden
  • Goteborg, Sweden, SE-416 85
    • Novartis Investigative Site
  • Stockholm, Sweden, SE-118 83
    • Novartis Investigative Site
• Switzerland
  • Bern, Switzerland, 3010
    • Novartis Investigative Site
  • Thun, Switzerland, 3600
    • Novartis Investigative Site
• Taiwan
  • Changhua, Taiwan
    • Novartis Investigative Site
  • Kaohsiung, Taiwan
    • Novartis Investigative Site
  • Keelung, Taiwan
    • Novartis Investigative Site
  • Taichung, Taiwan
    • Novartis Investigative Site
  • Tainan, Taiwan
    • Novartis Investigative Site
  • Taipei, Taiwan
    • Novartis Investigative Site
  • Tao-Yuan, Taiwan
    • Novartis Investigative Site
• United Kingdom
  • Belfast, United Kingdom, BT9 7AB
    • Novartis Investigative Site
  • Birmingham, United Kingdom, B15 2TH
    • Novartis Investigative Site
  • Cardiff, United Kingdom, CF147TB
    • Novartis Investigative Site
  • London, United Kingdom, W1T 3AA
    • Novartis Investigative Site
  • Manchester, United Kingdom, M20 4BX
    • Novartis Investigative Site
• United States
  • Alabama
    • Huntsville, Alabama, United States, 35801
      • Comprehensive Cancer Institute
  • Alaska
    • Anchorage, Alaska, United States, 99508
      • Alaska Oncology and Hematology
  • Arizona
    • Tucson, Arizona, United States, 85712
      • Arizona Clinical Research Center
  • Arkansas
    • Jonesboro, Arkansas, United States, 72401
      • Northeast Arkansas Clinic
    • Little Rock, Arkansas, United States, 72205
      • Arkansas Cancer Research Center
    • Little Rock, Arkansas, United States, 72205
      • Little Rock Hematology & Oncology
    • Springdale, Arkansas, United States, 72764
      • Highlands Oncology Group
  • California
    • Bakersfield, California, United States, 93309
      • Comprehensive Blood and Cancer Center
    • Burbank, California, United States, 91505
      • Providence St. Joseph Medical Center
    • Fountain Valley, California, United States, 92708
      • Compassionate Cancer Care Medical Group, Inc.
    • Fresno, California, United States, 93710
      • California Oncology of the Central Valley
    • Fullerton, California, United States, 92835
      • Virginia K. Crosson Cancer Center
    • Glendale, California, United States, 91206
      • Glendale Adventist Medical Center
    • La Jolla, California, United States, 92037
      • Scripps Green Hospital
    • La Verne, California, United States, 91767
      • Wilshire Oncology Medical Group
    • Long Beach, California, United States, 90813
      • Pacific Shores Medical Group
    • Los Angeles, California, United States, 90033
      • USC Norris Cancer Center
    • Los Angeles, California, United States, 90095
      • UCLA School of Medicine
    • Los Angeles, California, United States, 90095
      • Novartis Investigative Site
    • Los Angeles, California, United States, 90036
      • Synergy Hematology-Oncology Medical Associates
    • Monterey Park, California, United States, 91754
      • Eddie Hong-Lung Hu, M.D.
    • Northridge, California, United States, 91328
      • North Valley Hematology/Oncology Medical Group
    • Orange, California, United States, 92868
      • Medical Oncology Care Associates
    • Oxnard, California, United States, 93030
      • Ventura County Hematology-Oncology Specialists
    • Porterville, California, United States, 93257
      • Sierra View District Hospital
    • Redondo Beach, California, United States, 90277
      • Cancer Care Associates Medical Group, Inc.
    • San Jose, California, United States, 95128
      • Santa Clara Valley Medical Center
    • Santa Barbara, California, United States, 93105
      • Santa Barbara Hematology Oncology Medical Group, Inc.
    • Santa Barbara, California, United States, 93105
      • Sansum Santa Barbara Foundation Medical Clinic
    • Vista, California, United States, 92083
      • San Diego Cancer Center Medical Group
  • Colorado
    • Denver, Colorado, United States, 80210
      • Mile High Oncology
    • Denver, Colorado, United States, 80220
      • Rocky Mountain Cancer Center
  • Connecticut
    • Manchester, Connecticut, United States, 06040
      • Manchester Hematology/Oncology Assoc.
  • District of Columbia
    • Washington, District of Columbia, United States, 20037
      • Washington Oncology/Hematology Center
  • Florida
    • Boca Raton, Florida, United States, 33486
      • The Center for Hematology and Oncology
    • Ft. Myers, Florida, United States, 33901
      • Florida Cancer Specialists
    • Lake Worth, Florida, United States, 33461-4710
      • Hematology Oncology Associates
    • Miami, Florida, United States, 33136
      • University of Miami School of Medicine
    • Miami, Florida, United States, 33176
      • Oncology/Hematology Group of South Florida
    • Port St. Lucie, Florida, United States, 34952
      • Hematology Oncology Associates of Treasure Coast
    • Zephyrhills, Florida, United States, 33542
      • Florida Medical Clinic
  • Georgia
    • Marietta, Georgia, United States, 30060
      • Atlanta Cancer Care
    • Savannah, Georgia, United States, 31406
      • Coastal Hematology & Oncology
    • Savannah, Georgia, United States, 31405
      • Office of Research
    • Thomasville, Georgia, United States, 31792
      • Lewis Hall Singletary Oncology Center
  • Idaho
    • Coeur d'Alene, Idaho, United States, 83814
      • North Idaho Cancer Center
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago medical Center, Hematology/Oncology
    • Peoria, Illinois, United States, 61602
      • Oncology Hematology Associates of Central Illinois, PC
    • Skokie, Illinois, United States, 60077
      • Midwest Cancer Research Group
    • Skokie, Illinois, United States, 60076
      • Northshore Cancer Research Association
  • Indiana
    • Fort Wayne, Indiana, United States, 46815
      • Fort Wayne Medical Oncology & Hematology, Inc.
    • Munster, Indiana, United States, 46321
      • Munster Community Hospital
  • Kansas
    • Topeka, Kansas, United States, 66606
      • Cotton O'Neil Oncology Clinic
  • Kentucky
    • Louisville, Kentucky, United States, 40215
      • Vijay Raghaven, M.D.
    • Owensboro, Kentucky, United States, 42303
      • Owensboro Medical Health System
  • Louisiana
    • Alexandria, Louisiana, United States, 71301
      • Cabrini Center for Cancer Care
    • New Orleans, Louisiana, United States, 70112
      • Tulane University Health Sciences Center
    • New Orleans, Louisiana, United States, 70112
      • LSU Medical Center
    • Shreveport, Louisiana, United States, 71130-3932
      • LSU Health Sciences Center
  • Maine
    • Scarborough, Maine, United States, 04074
      • Maine Center for Cancer Medicine & Blood Disorders
  • Maryland
    • Baltimore, Maryland, United States, 21237
      • Franklin Square Hospital Center
    • Baltimore, Maryland, United States, 21229-5299
      • St. Agnes Healthcare
    • Rockville, Maryland, United States, 20850
      • Kaiser Permanente
  • Massachusetts
    • Worcester, Massachusetts, United States, 01605
      • Fallon Clinic at Worcester Medical Center
  • Michigan
    • Ann Arbor, Michigan, United States, 48109-0934
      • University of Michigan
    • Grand Rapids, Michigan, United States, 49503
      • Spectrum Health -- Cook Research Dept.
    • Southfield, Michigan, United States, 48075
      • Providence Cancer Center
    • St. Joseph, Michigan, United States, 49085
      • Oncology Care Associates, PLLC
  • Minnesota
    • Minneapolis, Minnesota, United States, 55407
      • Minnesota CGOP
  • Missouri
    • Kansas City, Missouri, United States, 64118
      • Heartland Hematology
    • St. Charles, Missouri, United States, 63301
      • Missouri Cancer Care, PC
    • St. Louis, Missouri, United States, 63110
      • Washington University School of Medicine
    • St. Louis, Missouri, United States, 63131
      • Missouri Baptist Cancer Center
    • St. Louis, Missouri, United States, 63110
      • Saint Louis University
    • St. Louis, Missouri, United States, 63141
      • Arch Medical Services Incorporated
  • Montana
    • Great Falls, Montana, United States, 59405
      • North Central Montana Professional Building
  • Nevada
    • Las Vegas, Nevada, United States, 89109
      • Comprehensive Cancer Centers of Nevada
    • Las Vegas, Nevada, United States, 89109
      • Nevada Cancer Center
  • New Hampshire
    • Hooksett, New Hampshire, United States, 03106
      • NH Oncology-Hematology, PA
  • New Jersey
    • Cherry Hill, New Jersey, United States, 08003
      • Center for Cancer and Hematologic Disease
    • Livingston, New Jersey, United States, 07039
      • St. Barnabas Cancer Center
    • Morristown, New Jersey, United States, 07960
      • Hematology Oncology Associates of Northern New Jersey
    • Voorhees, New Jersey, United States, 08043
      • Cooper Cancer Center
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • Hematology/Oncology Associates
    • Albuquerque, New Mexico, United States, 87109
      • New Mexico Oncology/Hematology
  • New York
    • Buffalo, New York, United States, 14263
      • Roswell Park Cancer Institute
    • East Syracuse, New York, United States, 13057
      • Hematology/Oncology Associates of Central NY
    • Fresh Meadows, New York, United States, 11365
      • Queens Medical Associates, PC
    • Glens Falls, New York, United States, 12801
      • Charles R. Wood Cancer Center
    • Manhasset, New York, United States, 11030
      • North Shore University Hospital
    • New York, New York, United States, 10011
      • St. Vincent's Catholic Medical Centers of New York
    • Nyack, New York, United States, 10956
      • Hematology-Oncology Associates of Rockland
    • Rochester, New York, United States, 14642
      • James P. Wilmot Cancer Center
    • Rochester, New York, United States, 14623
      • Pluta Cancer Center
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599-7305
      • Lineberger Comprehensive Cancer Center
    • Charlotte, North Carolina, United States, 28203
      • Carolinas Hematology/Oncology Associates
  • Ohio
    • Canton, Ohio, United States, 44718
      • Nashat Gabrail, M.D.
    • Cleveland, Ohio, United States, 44195
      • The Cleveland Clinic Foundation
    • Cleveland, Ohio, United States, 44106-5056
      • Case Western Reserve University
    • Columbus, Ohio, United States, 43206
      • Columbus CCOP
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • The University of Oklahoma Health Sciences Center
    • Tulsa, Oklahoma, United States, 74104
      • Oklahoma Oncology, Inc.
  • Pennsylvania
    • Drexel Hill, Pennsylvania, United States, 19026
      • Consultants in Medical Oncology & Hematology
    • Dunmore, Pennsylvania, United States, 18512
      • Hematology & Oncology Associates of NE PA
    • Hershey, Pennsylvania, United States, 17033-0850
      • Penn State Hershey Medical Center
    • Monongahela, Pennsylvania, United States, 15063
      • Monongahela Valley Hospital
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University Hospital
    • Pittsburgh, Pennsylvania, United States, 15212-4772
      • Allegheny General Hospital
    • Pittsburgh, Pennsylvania, United States, 15232
      • UPMC Cancer Pavillion
  • South Carolina
    • Charleston, South Carolina, United States, 29406
      • Charleston Cancer Center
    • Columbia, South Carolina, United States, 29201
      • South Carolina Oncology Associates
    • Columbia, South Carolina, United States, 29209
      • WJB Dom VAMC
    • Greenville, South Carolina, United States, 29615
      • Cancer Center Of The Carolinas
    • Spartanburg, South Carolina, United States, 29303
      • Spartanburg Regional Medical Center
  • Tennessee
    • Chattanooga, Tennessee, United States, 37403
      • Erlanger Health System
    • Clarksville, Tennessee, United States, 37043
      • Clarksville Regional Hematology/Oncology
    • Germantown, Tennessee, United States, 38138
      • The Jones Clinic
    • Knoxville, Tennessee, United States, 37920
      • Baptist Regional Cancer Center
    • Memphis, Tennessee, United States, 38104
      • University of Tennessee Cancer Institute
    • Nashville, Tennessee, United States, 37203
      • Sarah Cannon Cancer Center
    • Nashville, Tennessee, United States, 37208
      • Meharry Medical College
    • Nashville, Tennessee, United States, 37212
      • Vanderbilt-Ingram Cancer Center
    • Nashville, Tennessee, United States, 37232-6307
      • Vanderbilt University School of Medicine
  • Texas
    • Amarillo, Texas, United States, 79106
      • Harrington Cancer Center
    • Dallas, Texas, United States, 75230
      • Center for Oncology Research & Treatment
    • Dallas, Texas, United States, 75235
      • Clinical Hematology & Oncology
    • Houston, Texas, United States, 77030
      • M.D. Anderson Cancer Center
    • Houston, Texas, United States, 77024
      • Oncology Consultants
    • Houston, Texas, United States, 77030
      • H. Alejandro Preti, M.D., PA
    • San Antonio, Texas, United States, 78207
      • South Texas Oncology & Hematology
    • Temple, Texas, United States, 76508
      • Scott & White Hospital
  • Utah
    • Ogden, Utah, United States, 84403
      • Northern Utah Cancer Associates
  • Vermont
    • Bennington, Vermont, United States, 05201
      • Southwestern Vermont Health Care
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • Virginia Oncology Associates
    • Portsmouth, Virginia, United States, 23704
      • Cancer Treatment Centers of America in Hampton Roads
  • Washington
    • Everett, Washington, United States, 98201
      • Western Washington Clinic
    • Kirkland, Washington, United States, 98034
      • Cascade Cancer Center
    • Puyallup, Washington, United States, 98372
      • Rainier Oncology
    • Seattle, Washington, United States, 98101
      • Virginia Mason Medical Center
    • Seattle, Washington, United States, 98104
      • Swedish Cancer Institute
  • West Virginia
    • Morgantown, West Virginia, United States, 26506
      • West Virginia University Health Sciences Center
  • Wisconsin
    • Waukesha, Wisconsin, United States, 53188
      • Waukesha Memorial Hospital
    • West Bend, Wisconsin, United States, 53095
      • Kettle Morain Oncology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria

• 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

Exclusion criteria

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Oxaliplatin/5-FU/LV and PTK787/ZK 222584	Drug: Vatalanib; Other Names: PTK787/ZK 222584
Placebo Comparator: 2; Oxaliplatin/5-FU/LV and placebo	Drug: Vatalanib; Other Names: PTK787/ZK 222584

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall survival	throughout duration of study

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals
• Collaborators: Bayer
• Investigators: Study Chair: Novartis/Schering AG, Germany, Novartis / Schering AG Germany

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2003
• Primary Completion (Actual): January 1, 2007
• Study Completion (Actual): January 1, 2007

Study Registration Dates

• First Submitted: March 13, 2003
• First Submitted That Met QC Criteria: March 13, 2003
• First Posted (Estimate): March 14, 2003

Study Record Updates

• Last Update Posted (Actual): March 6, 2017
• Last Update Submitted That Met QC Criteria: March 2, 2017
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: Colorectal Cancer; Rectal Cancer; Colon Cancer; Colorectal Carcinoma; Oxaliplatin; Colorectal Tumor; Vatalanib; VEGF inhibitor; PTK787
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Neoplasms; Colorectal Neoplasms; Rectal Neoplasms; Colonic Neoplasms; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; Vatalanib
• Other Study ID Numbers: CPTK787 0133/304946