Study of Oxaliplatin/5-FU/Leucovorin Plus Vatalanib Versus Oxaliplatin/5-FU/Leucovorin in Patients With Metastatic Colorectal Cancer.

A Randomized, Double-blind, Placebo-controlled, Phase Lll Study in Patients With Metastatic Adenocarcinoma of the Colon or Rectum Who Are Receiving First-line Chemotherapy With Oxaliplatin/5-fluorouracil/Leucovorin With PTK787/ZK 222584 or Placebo

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 are seeking first chemotherapy treatment

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 1168
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • Adelaide, Australia, SA 5000
  • Garran, Australia, ACT 2605
  • Nedlands, Australia, WS 6009
  • Wollongong, Australia, NSW 2500
  • Woolloongabba, Australia, QLD 4102
• Belgium
  • Anderlecht, Belgium, 1070
  • Antwerpen, Belgium, 2020
  • Bruxelles, Belgium, 1200
  • Gent, Belgium, 9000
  • Wilrijk, Belgium, 2610
• Brazil
  • Porto Alegre, Brazil, CeP 90 610-000
  • Porto Alegre RS, Brazil, 90020-090
  • Salvador, Brazil, BA 41825-010
  • Sao Paulo, Brazil, 05651-901
  • Sao Paulo, Brazil, S01232-910
  • Sao Paulo, Brazil, S01308-050
• Canada
  • Ontario
    • Hamilton, Ontario, Canada
    • Toronto, Ontario, Canada
    • Toronto, Ontario, Canada, M5G 2M9
      • Novartis Investigative Site
  • Quebec
    • Sainte-Foy, Quebec, Canada
• Czechia
  • Brno, Czechia, 656 53
  • Praha 2, Czechia, 128 08
  • Praha 5, Czechia, 150 18
• France
  • Marseille Cedex 9, France, 13273
  • Marseille cedex 05, France, 13385
  • Strasbourg, France, 6700
• Germany
  • Augsburg, Germany, 86150
  • Berlin, Germany, 13353
  • Berlin, Germany, 14195
  • Dessau, Germany, 6822
  • Erlangen, Germany, 91054
  • Eschweiler, Germany, 52249
  • Essen, Germany, 45122
  • Frankfurt, Germany, 60488
  • Hannover, Germany, 30625
  • Heidelberg, Germany, 69115
  • Kiel, Germany, 24116
  • Köln, Germany, 50677
  • Leipzig, Germany, 4103
  • Magdeburg, Germany, 39002
• Hungary
  • Budapest, Hungary, H-1097
  • Budapest, Hungary, H-1032
  • Gyor, Hungary, H-9002
  • Szeged, Hungary, H-6725
• Italy
  • Forli, Italy, 47100
  • Genova, Italy, 16132
  • Milano, Italy, 20162
  • Modena, Italy, 41100
  • Roma, Italy, 135
  • Roma, Italy, 144
  • Rozzano, Italy, 20089
  • Torino, Italy, 10126
• Netherlands
  • GA Utrecht, Netherlands, 3508
• New Zealand
  • Hamilton, New Zealand
    • Novartis Investigative Site
  • Palmerston North, New Zealand
• Portugal
  • Coimbra, Portugal, 3000-076
• Slovakia
  • Bratislava, Slovakia, 833 10
    • Novartis Investigative Site
  • Bratislava, Slovakia, 81250
    • Novartis Investigative Site
  • Kosice, Slovakia, 041 90
    • Novartis Investigative Site
  • Zilina, Slovakia, 012 07
    • Novartis Investigative Site
• Spain
  • Alicante, Spain, 3202
  • Madrid, Spain, 28041
  • Madrid, Spain, 28033
  • Madrid, Spain, 28035
  • Malaga, Spain, 29010
  • Zaragoza, Spain, 50009
• Sweden
  • Stockholm, Sweden, SE-118 83
• Switzerland
  • Basel, Switzerland, 4031
  • Bern, Switzerland, 3010
  • Thun, Switzerland, 3600
  • Zurich, Switzerland, 8027
  • Zürich, Switzerland, 8091
• Taiwan
  • Tainan, Taiwan
  • Taipei, Taiwan
  • Tao-Yuan, Taiwan
• United Kingdom
  • Belfast, United Kingdom, BT9 7AB
  • Leicester, United Kingdom, LE1 5WW
  • Oxford, United Kingdom, OX3 7LJ
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35243
      • Alabama Hematology/Oncology
  • Arizona
    • Glendale, Arizona, United States, 85304
      • Palo Verde Hematology & Oncology
    • Tucson, Arizona, United States, 85724
      • Arizona Cancer Center
  • Arkansas
    • Jonesboro, Arkansas, United States, 72401
      • Northeast Arkansas Clinic
    • 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
    • Gilroy, California, United States, 95020
      • Ronald Yanagiharaa, M.D.
    • Glendale, California, United States, 91206
      • Glendale Adventist Medical Center Cancer Center
    • Long Beach, California, United States, 90813
      • Pacific Shores Medical Group
    • Los Angeles, California, United States, 90095
      • UCLA School of Medicine
    • Los Angeles, California, United States, 90025
      • Cancer Institute Medical Group
    • Los Angeles, California, United States, 90033
      • USC/Norris Comprehensive Cancer Care Center
    • Los Angeles, California, United States, 90057
      • 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
    • Oxnard, California, United States, 93030
      • Ventura County Hematology-Oncology Specialists
    • Pomona, California, United States, 91767
      • Wilshire Oncology Medical Group
    • Porterville, California, United States, 93257
      • Sierra View District Hospital
    • Rancho Mirage, California, United States, 92270
      • The Lucy Curci Cancer Center
    • Redondo Beach, California, United States, 90277
      • Cancer Care Associates Medical Group, Inc.
    • San Francisco, California, United States, 94904
      • Pacific Hematology Oncology Associates
    • 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, 80224
      • Colorado Cancer Research Program
    • Wheat Ridge, Colorado, United States, 08833
      • Jennifer Caskey, M.D.
  • Connecticut
    • Manchester, Connecticut, United States, 06040
      • Davis, Posteraro and Wasser, MD's, LLP
    • Middletown, Connecticut, United States, 06457
      • Connecticut Oncology Group
  • Delaware
    • Newark, Delaware, United States, 19808
      • Medical Oncology Hematology Consultants
  • District of Columbia
    • Washington, District of Columbia, United States, 20037
      • George Washington University Medical Center
    • Washington, District of Columbia, United States, 20016
      • Washington Oncology-Hematology Center
  • Florida
    • Boca Raton, Florida, United States, 33486
      • Boca Raton Comprehensive Cancer Center
    • Fort Myers, Florida, United States, 33901
      • Florida Cancer Specialists
    • Hollywood, Florida, United States, 33021
      • Memorial Healthcare System
    • Jacksonville, Florida, United States, 32204
      • Florida Oncology Associates
    • Lakeland, Florida, United States, 33803
      • Lakeland Regional Cancer Center
    • Miami, Florida, United States, 33176
      • Oncology Hematology Group of South Florida
    • Miami Shores, Florida, United States, 33138
      • Innovative Medical Research of South Florida
    • Port Saint Lucie, Florida, United States, 34952
      • Hematology Oncology Associates of Treasure
    • Zephyrhills, Florida, United States, 33542
      • Florida Medical Clinic, PA
  • Georgia
    • Atlanta, Georgia, United States, 40202
      • Peachtree Hematology and Oncology
    • Savannah, Georgia, United States, 31406
      • Coastal Hematology & Oncology
  • Idaho
    • Coeur d'Alene, Idaho, United States, 83814
      • North Idaho Cancer Center
  • Illinois
    • Arlington Heights, Illinois, United States, 60004
      • Shelby D. Rifkin, M.D.
    • Harvey, Illinois, United States, 60426
      • Monroe Medical Associates
    • 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
    • Indianapolis, Indiana, United States, 46260
      • Hematology-Oncology of Indiana, PC
    • Terre Haute, Indiana, United States, 47804
      • Associated Physicians & Surgeons Clinic, L.L.C.
  • Kentucky
    • Lexington, Kentucky, United States, 40536-0098
      • Markey Clinical Oncology Research Program
    • Louisville, Kentucky, United States, 40202
      • Norton Healthcare Pavilion
    • Louisville, Kentucky, United States, 40215
      • Vijay Raghavan, M.D.
  • Louisiana
    • Lafayette, Louisiana, United States, 70506
      • Louisiana Oncology Associates
    • 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, 21229-5299
      • St. Agnes Healthcare, Inc.
    • Rockville, Maryland, United States, 20850
      • Kaiser Permanente
  • Michigan
    • Ann Arbor, Michigan, United States, 48106-0995
      • St. Joseph Mercy Hospital
    • Detroit, Michigan, United States, 48202
      • Josephine Ford Cancer Center
    • Flint, Michigan, United States, 48503
      • Genesys Hurley Cancer Institute
    • Grand Rapids, Michigan, United States, 49503
      • Spectrum Health -- Cook Research Dept.
    • Jackson, Michigan, United States, 48201
      • Hematology and Oncology Assoc. of Southern Mississippi
    • Saint Joseph, Michigan, United States, 49085
      • Oncology Care Associates, PLLC
    • Southfield, Michigan, United States, 48075
      • Providence Cancer Center
  • Minnesota
    • Duluth, Minnesota, United States, 55805
      • SMDC Health System
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota Cancer Center
    • Minneapolis, Minnesota, United States, 55407
      • Minnesota CGOP
    • Saint Louis Park, Minnesota, United States, 55426
      • Metro Minnesota CCOP
  • Missouri
    • Kansas City, Missouri, United States, 64131
      • Kansas City Oncology and Hematology Group
    • Kansas City, Missouri, United States, 64118
      • Heartland Hematology/Oncology Associates, Inc.
    • Saint Charles, Missouri, United States, 63301
      • Missouri Cancer Care, PC
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine
    • Saint Louis, Missouri, United States, 63131
      • Missouri Baptist Cancer Center
    • Saint Louis, Missouri, United States, 63110
      • Saint Louis University
    • Saint Louis, Missouri, United States, 63141
      • Arch Medical Services Incorporated
  • Montana
    • Great Falls, Montana, United States, 59405
      • North Central Montana Professional Building
    • Missoula, Montana, United States, 59807-7877
      • Montana Cancer Specialists
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • The Methodist Cancer Center
  • Nevada
    • Las Vegas, Nevada, United States, 89109
      • Comprehensive Cancer Centers of Nevada
    • Las Vegas, Nevada, United States, 89109
      • Nevada Cancer Center
  • New Jersey
    • Cherry Hill, New Jersey, United States, 08003
      • The 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 New Jersey
    • Vineland, New Jersey, United States, 08360
      • Southern Oncology and Hematology Associates
    • Voorhees, New Jersey, United States, 08043
      • Cooper Cancer Institute
  • New Mexico
    • Santa Fe, New Mexico, United States, 87505
      • New Mexico Cancer Care
  • New York
    • Buffalo, New York, United States, 14263
      • Roswell Park Cancer Institute
    • Glens Falls, New York, United States, 12801
      • CR Wood Cancer Center
    • Great Neck, New York, United States, 11023
      • Cancer Research of Long Island
    • Johnson City, New York, United States, 13790
      • Broome Oncology
    • Latham, New York, United States, 12110
      • New York Oncology Hematology
    • Manhasset, New York, United States, 11030
      • North Shore University Hospital
    • Nyack, New York, United States, 10960
      • Cancer Center at Nyack Hospital
    • Rochester, New York, United States, 14623
      • Pluta Cancer Center
  • North Carolina
    • Charlotte, North Carolina, United States, 28203
      • Carolina Medical Center
  • North Dakota
    • Bismarck, North Dakota, United States, 58501
      • Mid-Dakota Clinic PC
  • Ohio
    • Canton, Ohio, United States, 44718
      • Nashat Gabrail, M.D.
    • Columbus, Ohio, United States, 43235
      • Hematology Oncology Consultants, Inc.
    • Columbus, Ohio, United States, 43213
      • Mid Ohio Oncology/Hematology, Inc.
    • Mayfield Heights, Ohio, United States, 44124
      • Meridia Cancer Institute
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Cancer Care Associates
    • Tulsa, Oklahoma, United States, 74136-1929
      • Cancer Care Associates
  • Oregon
    • Portland, Oregon, United States, 97227
      • Kaiser Permanente Oncology Hematology
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Hershey Medical Center
    • Monongahela, Pennsylvania, United States, 15063
      • Monogahela Valley Hospital
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania Abramson Cancer Center
    • Pittsburgh, Pennsylvania, United States, 15212-4772
      • Allegheny Cancer Center
  • South Carolina
    • Charleston, South Carolina, United States, 29403
      • Charleston Hematology Oncology
    • Charleston, South Carolina, United States, 29406
      • Charleston Cancer Center
    • Columbia, South Carolina, United States, 29201
      • South Carolina Oncology Associates
    • Greenville, South Carolina, United States, 29615
      • Cancer Center Of The Carolinas
    • Spartanburg, South Carolina, United States, 29303
      • Spartanburg Regional Medical Center
  • Tennessee
    • 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
  • Texas
    • Austin, Texas, United States, 78705
      • Southwest Regional Cancer Center
    • Corpus Christi, Texas, United States, 78412
      • Corpus Christi Cancer Center
    • Dallas, Texas, United States, 75230
      • Center for Oncology Research & Treatment, PA
    • 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, MD, PA
    • Irving, Texas, United States, 75038
      • Dr. Lee C. Drinkard
    • Temple, Texas, United States, 76508
      • Scott & White Hospital
  • Utah
    • Ogden, Utah, United States, 84403-3105
      • North Utah Associates
    • Salt Lake City, Utah, United States, 84124
      • Utah Cancer Specialists
  • Vermont
    • Bennington, Vermont, United States, 05201
      • Southwestern Vermont Health Care
  • Virginia
    • Danville, Virginia, United States, 24541
      • Danville Hematology and Oncology, Inc.
    • Fairfax, Virginia, United States, 22031
      • Northern Virginia Oncology Group
    • Norfolk, Virginia, United States, 23502
      • Virginia Oncology Associates
    • Portsmouth, Virginia, United States, 23704
      • Cancer Treatment Centers of America
    • Richmond, Virginia, United States, 23230
      • Virginia Cancer Institute
  • Washington
    • Everett, Washington, United States, 98201
      • Western Washington Medical Group
    • Everett, Washington, United States, 982901
      • Western Washington Medical Group
    • Kirkland, Washington, United States, 98034
      • Cascade Cancer Center
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • UW Health -- University of Wisconsin Comp
    • Waukesha, Wisconsin, United States, 53188
      • Waukesha Memorial Hospital

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:

• Patients with metastatic colorectal cancer coming for initial chemotherapy
• 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:

• History or presence of central nervous system disease
• 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

Other protocol-defined inclusion / exclusion criteria may apply

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
Progression free survival	Throughout duration of study

Secondary Outcome Measures

Outcome Measure	Time Frame
Time to progression	Throughout duration of study
Time to treatment failure	Throughout duration of study
Best overall response rate	Throughout duration of study
Tolerability and safety profile	Throughout duration of study

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2003
• Primary 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): February 10, 2020
• Last Update Submitted That Met QC Criteria: February 6, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Angiogenesis; 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 0135/306241; CONFIRM 1