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

Primary Purpose

Colorectal Neoplasms, Colonic Neoplasms, Rectal Neoplasms

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Vatalanib
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Neoplasms focused on measuring Colorectal Cancer, Oxaliplatin, VEGF inhibitor, Vatalanib, PTK787, Colon Cancer, Colorectal Carcinoma, Rectal Cancer, Colorectal Tumor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Comprehensive Cancer Institute
  • Alaska Oncology and Hematology
  • Arizona Clinical Research Center
  • Northeast Arkansas Clinic
  • Arkansas Cancer Research Center
  • Little Rock Hematology & Oncology
  • Highlands Oncology Group
  • Comprehensive Blood and Cancer Center
  • Providence St. Joseph Medical Center
  • Compassionate Cancer Care Medical Group, Inc.
  • California Oncology of the Central Valley
  • Virginia K. Crosson Cancer Center
  • Glendale Adventist Medical Center
  • Scripps Green Hospital
  • Wilshire Oncology Medical Group
  • Pacific Shores Medical Group
  • USC Norris Cancer Center
  • Synergy Hematology-Oncology Medical Associates
  • Novartis Investigative Site
  • UCLA School of Medicine
  • Eddie Hong-Lung Hu, M.D.
  • North Valley Hematology/Oncology Medical Group
  • Medical Oncology Care Associates
  • Ventura County Hematology-Oncology Specialists
  • Sierra View District Hospital
  • Cancer Care Associates Medical Group, Inc.
  • Santa Clara Valley Medical Center
  • Sansum Santa Barbara Foundation Medical Clinic
  • Santa Barbara Hematology Oncology Medical Group, Inc.
  • San Diego Cancer Center Medical Group
  • Mile High Oncology
  • Rocky Mountain Cancer Center
  • Manchester Hematology/Oncology Assoc.
  • Washington Oncology/Hematology Center
  • The Center for Hematology and Oncology
  • Florida Cancer Specialists
  • Hematology Oncology Associates
  • University of Miami School of Medicine
  • Oncology/Hematology Group of South Florida
  • Hematology Oncology Associates of Treasure Coast
  • Florida Medical Clinic
  • Atlanta Cancer Care
  • Office of Research
  • Coastal Hematology & Oncology
  • Lewis Hall Singletary Oncology Center
  • North Idaho Cancer Center
  • University of Chicago medical Center, Hematology/Oncology
  • Oncology Hematology Associates of Central Illinois, PC
  • Northshore Cancer Research Association
  • Midwest Cancer Research Group
  • Fort Wayne Medical Oncology & Hematology, Inc.
  • Munster Community Hospital
  • Cotton O'Neil Oncology Clinic
  • Vijay Raghaven, M.D.
  • Owensboro Medical Health System
  • Cabrini Center for Cancer Care
  • LSU Medical Center
  • Tulane University Health Sciences Center
  • LSU Health Sciences Center
  • Maine Center for Cancer Medicine & Blood Disorders
  • St. Agnes Healthcare
  • Franklin Square Hospital Center
  • Kaiser Permanente
  • Fallon Clinic at Worcester Medical Center
  • University of Michigan
  • Spectrum Health -- Cook Research Dept.
  • Providence Cancer Center
  • Oncology Care Associates, PLLC
  • Minnesota CGOP
  • Heartland Hematology
  • Missouri Cancer Care, PC
  • Saint Louis University
  • Washington University School of Medicine
  • Missouri Baptist Cancer Center
  • Arch Medical Services Incorporated
  • North Central Montana Professional Building
  • Comprehensive Cancer Centers of Nevada
  • Nevada Cancer Center
  • NH Oncology-Hematology, PA
  • Center for Cancer and Hematologic Disease
  • St. Barnabas Cancer Center
  • Hematology Oncology Associates of Northern New Jersey
  • Cooper Cancer Center
  • Hematology/Oncology Associates
  • New Mexico Oncology/Hematology
  • Roswell Park Cancer Institute
  • Hematology/Oncology Associates of Central NY
  • Queens Medical Associates, PC
  • Charles R. Wood Cancer Center
  • North Shore University Hospital
  • St. Vincent's Catholic Medical Centers of New York
  • Hematology-Oncology Associates of Rockland
  • Pluta Cancer Center
  • James P. Wilmot Cancer Center
  • Lineberger Comprehensive Cancer Center
  • Carolinas Hematology/Oncology Associates
  • Nashat Gabrail, M.D.
  • Case Western Reserve University
  • The Cleveland Clinic Foundation
  • Columbus CCOP
  • The University of Oklahoma Health Sciences Center
  • Oklahoma Oncology, Inc.
  • Consultants in Medical Oncology & Hematology
  • Hematology & Oncology Associates of NE PA
  • Penn State Hershey Medical Center
  • Monongahela Valley Hospital
  • Thomas Jefferson University Hospital
  • Allegheny General Hospital
  • UPMC Cancer Pavillion
  • Charleston Cancer Center
  • South Carolina Oncology Associates
  • WJB Dom VAMC
  • Cancer Center of the Carolinas
  • Spartanburg Regional Medical Center
  • Erlanger Health System
  • Clarksville Regional Hematology/Oncology
  • The Jones Clinic
  • Baptist Regional Cancer Center
  • University of Tennessee Cancer Institute
  • Sarah Cannon Cancer Center
  • Meharry Medical College
  • Vanderbilt-Ingram Cancer Center
  • Vanderbilt University School of Medicine
  • Harrington Cancer Center
  • Center for Oncology Research & Treatment
  • Clinical Hematology & Oncology
  • Oncology Consultants
  • H. Alejandro Preti, M.D., PA
  • M.D. Anderson Cancer Center
  • South Texas Oncology & Hematology
  • Scott & White Hospital
  • Northern Utah Cancer Associates
  • Southwestern Vermont Health Care
  • Virginia Oncology Associates
  • Cancer Treatment Centers of America in Hampton Roads
  • Western Washington Clinic
  • Cascade Cancer Center
  • Rainier Oncology
  • Virginia Mason Medical Center
  • Swedish Cancer Institute
  • West Virginia University Health Sciences Center
  • Waukesha Memorial Hospital
  • Kettle Morain Oncology
  • Novartis Investigative Site
  • Novartis Investigative Site
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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Oxaliplatin/5-FU/LV and PTK787/ZK 222584

Oxaliplatin/5-FU/LV and placebo

Outcomes

Primary Outcome Measures

Overall survival

Secondary Outcome Measures

Progression free survival
Time to progression
Time to treatment failure
Tumor response rate
Tolerability and safety profile

Full Information

First Posted
March 13, 2003
Last Updated
March 2, 2017
Sponsor
Novartis Pharmaceuticals
Collaborators
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT00056446
Brief Title
Study of Oxaliplatin/5-FU/Leucovorin Plus Vatalanib Versus Oxaliplatin/5-FU/Leucovorin in Patients With Previously Treated Metastatic Colorectal Cancer
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
January 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
Collaborators
Bayer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Neoplasms, Colonic Neoplasms, Rectal Neoplasms
Keywords
Colorectal Cancer, Oxaliplatin, VEGF inhibitor, Vatalanib, PTK787, Colon Cancer, Colorectal Carcinoma, Rectal Cancer, Colorectal Tumor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
855 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Oxaliplatin/5-FU/LV and PTK787/ZK 222584
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Oxaliplatin/5-FU/LV and placebo
Intervention Type
Drug
Intervention Name(s)
Vatalanib
Other Intervention Name(s)
PTK787/ZK 222584
Primary Outcome Measure Information:
Title
Overall survival
Time Frame
throughout duration of study
Secondary Outcome Measure Information:
Title
Progression free survival
Time Frame
throughout duration of study
Title
Time to progression
Time Frame
throughout duration of study
Title
Time to treatment failure
Time Frame
throughout duration of study
Title
Tumor response rate
Time Frame
throughout duration of study
Title
Tolerability and safety profile
Time Frame
throughout duration of study

10. Eligibility

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

12. IPD Sharing Statement

Citations:
PubMed Identifier
21464401
Citation
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.
Results Reference
result

Learn more about this trial

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

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