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Study of Oxaliplatin/5-FU/Leucovorin Plus Vatalanib Versus Oxaliplatin/5-FU/Leucovorin in Patients With 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
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

Eligibility Criteria

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

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

Sites / Locations

  • Alabama Hematology/Oncology
  • Palo Verde Hematology & Oncology
  • Arizona Cancer Center
  • Northeast Arkansas Clinic
  • 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
  • Ronald Yanagiharaa, M.D.
  • Glendale Adventist Medical Center Cancer Center
  • Pacific Shores Medical Group
  • Cancer Institute Medical Group
  • USC/Norris Comprehensive Cancer Care Center
  • Synergy Hematology-Oncology Medical Associates
  • UCLA School of Medicine
  • Eddie Hong-Lung Hu, M.D.
  • North Valley Hematology/Oncology Medical Group
  • Ventura County Hematology-Oncology Specialists
  • Wilshire Oncology Medical Group
  • Sierra View District Hospital
  • The Lucy Curci Cancer Center
  • Cancer Care Associates Medical Group, Inc.
  • Pacific Hematology Oncology Associates
  • Santa Clara Valley Medical Center
  • Sansum Santa Barbara Foundation Medical Clinic
  • Santa Barbara Hematology Oncology Medical Group, Inc.
  • San Diego Cancer Center Medical Group
  • Colorado Cancer Research Program
  • Jennifer Caskey, M.D.
  • Davis, Posteraro and Wasser, MD's, LLP
  • Connecticut Oncology Group
  • Medical Oncology Hematology Consultants
  • Washington Oncology-Hematology Center
  • George Washington University Medical Center
  • Boca Raton Comprehensive Cancer Center
  • Florida Cancer Specialists
  • Memorial Healthcare System
  • Florida Oncology Associates
  • Lakeland Regional Cancer Center
  • Innovative Medical Research of South Florida
  • Oncology Hematology Group of South Florida
  • Hematology Oncology Associates of Treasure
  • Florida Medical Clinic, PA
  • Peachtree Hematology and Oncology
  • Coastal Hematology & Oncology
  • North Idaho Cancer Center
  • Shelby D. Rifkin, M.D.
  • Monroe Medical Associates
  • Oncology Hematology Associates of Central Illinois, PC
  • Northshore Cancer Research Association
  • Midwest Cancer Research Group
  • Hematology-Oncology of Indiana, PC
  • Associated Physicians & Surgeons Clinic, L.L.C.
  • Markey Clinical Oncology Research Program
  • Norton Healthcare Pavilion
  • Vijay Raghavan, M.D.
  • Louisiana Oncology Associates
  • LSU Medical Center
  • Tulane University Health Sciences Center
  • LSU Health Sciences Center
  • Maine Center for Cancer Medicine & Blood Disorders
  • St. Agnes Healthcare, Inc.
  • Kaiser Permanente
  • St. Joseph Mercy Hospital
  • Josephine Ford Cancer Center
  • Genesys Hurley Cancer Institute
  • Spectrum Health -- Cook Research Dept.
  • Hematology and Oncology Assoc. of Southern Mississippi
  • Oncology Care Associates, PLLC
  • Providence Cancer Center
  • SMDC Health System
  • Minnesota CGOP
  • University of Minnesota Cancer Center
  • Metro Minnesota CCOP
  • Heartland Hematology/Oncology Associates, Inc.
  • Kansas City Oncology and Hematology Group
  • 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
  • Montana Cancer Specialists
  • The Methodist Cancer Center
  • Comprehensive Cancer Centers of Nevada
  • Nevada Cancer Center
  • The Center for Cancer and Hematologic Disease
  • St. Barnabas Cancer Center
  • Hematology-Oncology Associates of New Jersey
  • Southern Oncology and Hematology Associates
  • Cooper Cancer Institute
  • New Mexico Cancer Care
  • Roswell Park Cancer Institute
  • CR Wood Cancer Center
  • Cancer Research of Long Island
  • Broome Oncology
  • New York Oncology Hematology
  • North Shore University Hospital
  • Cancer Center at Nyack Hospital
  • Pluta Cancer Center
  • Carolina Medical Center
  • Mid-Dakota Clinic PC
  • Nashat Gabrail, M.D.
  • Mid Ohio Oncology/Hematology, Inc.
  • Hematology Oncology Consultants, Inc.
  • Meridia Cancer Institute
  • Cancer Care Associates
  • Cancer Care Associates
  • Kaiser Permanente Oncology Hematology
  • Hershey Medical Center
  • Monogahela Valley Hospital
  • University of Pennsylvania Abramson Cancer Center
  • Allegheny Cancer Center
  • Charleston Hematology Oncology
  • Charleston Cancer Center
  • South Carolina Oncology Associates
  • Cancer Center of the Carolinas
  • Spartanburg Regional Medical Center
  • The Jones Clinic
  • Baptist Regional Cancer Center
  • University of Tennessee Cancer Institute
  • Sarah Cannon Cancer Center
  • Southwest Regional Cancer Center
  • Corpus Christi Cancer Center
  • Center for Oncology Research & Treatment, PA
  • Oncology Consultants
  • H. Alejandro Preti, MD, PA
  • M.D. Anderson Cancer Center
  • Dr. Lee C. Drinkard
  • Scott & White Hospital
  • North Utah Associates
  • Utah Cancer Specialists
  • Southwestern Vermont Health Care
  • Danville Hematology and Oncology, Inc.
  • Northern Virginia Oncology Group
  • Virginia Oncology Associates
  • Cancer Treatment Centers of America
  • Virginia Cancer Institute
  • Western Washington Medical Group
  • Western Washington Medical Group
  • Cascade Cancer Center
  • UW Health -- University of Wisconsin Comp
  • Waukesha Memorial Hospital
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

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

Progression free survival

Secondary Outcome Measures

Time to progression
Time to treatment failure
Best overall response rate
Tolerability and safety profile

Full Information

First Posted
March 13, 2003
Last Updated
February 6, 2020
Sponsor
Novartis
Collaborators
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT00056459
Brief Title
Study of Oxaliplatin/5-FU/Leucovorin Plus Vatalanib Versus Oxaliplatin/5-FU/Leucovorin in Patients With Metastatic Colorectal Cancer.
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
February 2003 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Novartis
Collaborators
Bayer

4. Oversight

5. Study Description

Brief Summary
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

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, PTK787, Vatalanib, VEGF inhibitor, Oxaliplatin, Angiogenesis, Rectal Cancer, Colon Cancer, Colorectal Carcinoma, Colorectal Tumor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
1168 (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
Progression free survival
Time Frame
Throughout duration of study
Secondary Outcome Measure Information:
Title
Time to progression
Time Frame
Throughout duration of study
Title
Time to treatment failure
Time Frame
Throughout duration of study
Title
Best overall 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: 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
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
Alabama Hematology/Oncology
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35243
Country
United States
Facility Name
Palo Verde Hematology & Oncology
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85304
Country
United States
Facility Name
Arizona Cancer Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Northeast Arkansas Clinic
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
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
Ronald Yanagiharaa, M.D.
City
Gilroy
State/Province
California
ZIP/Postal Code
95020
Country
United States
Facility Name
Glendale Adventist Medical Center Cancer Center
City
Glendale
State/Province
California
ZIP/Postal Code
91206
Country
United States
Facility Name
Pacific Shores Medical Group
City
Long Beach
State/Province
California
ZIP/Postal Code
90813
Country
United States
Facility Name
Cancer Institute Medical Group
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Facility Name
USC/Norris Comprehensive Cancer Care 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
90057
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
Ventura County Hematology-Oncology Specialists
City
Oxnard
State/Province
California
ZIP/Postal Code
93030
Country
United States
Facility Name
Wilshire Oncology Medical Group
City
Pomona
State/Province
California
ZIP/Postal Code
91767
Country
United States
Facility Name
Sierra View District Hospital
City
Porterville
State/Province
California
ZIP/Postal Code
93257
Country
United States
Facility Name
The Lucy Curci Cancer Center
City
Rancho Mirage
State/Province
California
ZIP/Postal Code
92270
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
Pacific Hematology Oncology Associates
City
San Francisco
State/Province
California
ZIP/Postal Code
94904
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
Colorado Cancer Research Program
City
Denver
State/Province
Colorado
ZIP/Postal Code
80224
Country
United States
Facility Name
Jennifer Caskey, M.D.
City
Wheat Ridge
State/Province
Colorado
ZIP/Postal Code
08833
Country
United States
Facility Name
Davis, Posteraro and Wasser, MD's, LLP
City
Manchester
State/Province
Connecticut
ZIP/Postal Code
06040
Country
United States
Facility Name
Connecticut Oncology Group
City
Middletown
State/Province
Connecticut
ZIP/Postal Code
06457
Country
United States
Facility Name
Medical Oncology Hematology Consultants
City
Newark
State/Province
Delaware
ZIP/Postal Code
19808
Country
United States
Facility Name
Washington Oncology-Hematology Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20016
Country
United States
Facility Name
George Washington University Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Boca Raton Comprehensive Cancer Center
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
Florida Cancer Specialists
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Facility Name
Memorial Healthcare System
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Florida Oncology Associates
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32204
Country
United States
Facility Name
Lakeland Regional Cancer Center
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33803
Country
United States
Facility Name
Innovative Medical Research of South Florida
City
Miami Shores
State/Province
Florida
ZIP/Postal Code
33138
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
City
Port Saint Lucie
State/Province
Florida
ZIP/Postal Code
34952
Country
United States
Facility Name
Florida Medical Clinic, PA
City
Zephyrhills
State/Province
Florida
ZIP/Postal Code
33542
Country
United States
Facility Name
Peachtree Hematology and Oncology
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
40202
Country
United States
Facility Name
Coastal Hematology & Oncology
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
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
Shelby D. Rifkin, M.D.
City
Arlington Heights
State/Province
Illinois
ZIP/Postal Code
60004
Country
United States
Facility Name
Monroe Medical Associates
City
Harvey
State/Province
Illinois
ZIP/Postal Code
60426
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
Hematology-Oncology of Indiana, PC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Associated Physicians & Surgeons Clinic, L.L.C.
City
Terre Haute
State/Province
Indiana
ZIP/Postal Code
47804
Country
United States
Facility Name
Markey Clinical Oncology Research Program
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536-0098
Country
United States
Facility Name
Norton Healthcare Pavilion
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Vijay Raghavan, M.D.
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40215
Country
United States
Facility Name
Louisiana Oncology Associates
City
Lafayette
State/Province
Louisiana
ZIP/Postal Code
70506
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, Inc.
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21229-5299
Country
United States
Facility Name
Kaiser Permanente
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
St. Joseph Mercy Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106-0995
Country
United States
Facility Name
Josephine Ford Cancer Center
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Genesys Hurley Cancer Institute
City
Flint
State/Province
Michigan
ZIP/Postal Code
48503
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
Hematology and Oncology Assoc. of Southern Mississippi
City
Jackson
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Oncology Care Associates, PLLC
City
Saint Joseph
State/Province
Michigan
ZIP/Postal Code
49085
Country
United States
Facility Name
Providence Cancer Center
City
Southfield
State/Province
Michigan
ZIP/Postal Code
48075
Country
United States
Facility Name
SMDC Health System
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805
Country
United States
Facility Name
Minnesota CGOP
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
University of Minnesota Cancer Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Metro Minnesota CCOP
City
Saint Louis Park
State/Province
Minnesota
ZIP/Postal Code
55426
Country
United States
Facility Name
Heartland Hematology/Oncology Associates, Inc.
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64118
Country
United States
Facility Name
Kansas City Oncology and Hematology Group
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64131
Country
United States
Facility Name
Missouri Cancer Care, PC
City
Saint Charles
State/Province
Missouri
ZIP/Postal Code
63301
Country
United States
Facility Name
Saint Louis University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Missouri Baptist Cancer Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63131
Country
United States
Facility Name
Arch Medical Services Incorporated
City
Saint 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
Montana Cancer Specialists
City
Missoula
State/Province
Montana
ZIP/Postal Code
59807-7877
Country
United States
Facility Name
The Methodist Cancer Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
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
The 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 New Jersey
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Facility Name
Southern Oncology and Hematology Associates
City
Vineland
State/Province
New Jersey
ZIP/Postal Code
08360
Country
United States
Facility Name
Cooper Cancer Institute
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043
Country
United States
Facility Name
New Mexico Cancer Care
City
Santa Fe
State/Province
New Mexico
ZIP/Postal Code
87505
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
CR Wood Cancer Center
City
Glens Falls
State/Province
New York
ZIP/Postal Code
12801
Country
United States
Facility Name
Cancer Research of Long Island
City
Great Neck
State/Province
New York
ZIP/Postal Code
11023
Country
United States
Facility Name
Broome Oncology
City
Johnson City
State/Province
New York
ZIP/Postal Code
13790
Country
United States
Facility Name
New York Oncology Hematology
City
Latham
State/Province
New York
ZIP/Postal Code
12110
Country
United States
Facility Name
North Shore University Hospital
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
Cancer Center at Nyack Hospital
City
Nyack
State/Province
New York
ZIP/Postal Code
10960
Country
United States
Facility Name
Pluta Cancer Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14623
Country
United States
Facility Name
Carolina Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
Mid-Dakota Clinic PC
City
Bismarck
State/Province
North Dakota
ZIP/Postal Code
58501
Country
United States
Facility Name
Nashat Gabrail, M.D.
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Mid Ohio Oncology/Hematology, Inc.
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Facility Name
Hematology Oncology Consultants, Inc.
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43235
Country
United States
Facility Name
Meridia Cancer Institute
City
Mayfield Heights
State/Province
Ohio
ZIP/Postal Code
44124
Country
United States
Facility Name
Cancer Care Associates
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Cancer Care Associates
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136-1929
Country
United States
Facility Name
Kaiser Permanente Oncology Hematology
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States
Facility Name
Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Monogahela Valley Hospital
City
Monongahela
State/Province
Pennsylvania
ZIP/Postal Code
15063
Country
United States
Facility Name
University of Pennsylvania Abramson Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Allegheny Cancer Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212-4772
Country
United States
Facility Name
Charleston Hematology Oncology
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29403
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
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
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
Southwest Regional Cancer Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Corpus Christi Cancer Center
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78412
Country
United States
Facility Name
Center for Oncology Research & Treatment, PA
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Oncology Consultants
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Facility Name
H. Alejandro Preti, MD, 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
Dr. Lee C. Drinkard
City
Irving
State/Province
Texas
ZIP/Postal Code
75038
Country
United States
Facility Name
Scott & White Hospital
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
North Utah Associates
City
Ogden
State/Province
Utah
ZIP/Postal Code
84403-3105
Country
United States
Facility Name
Utah Cancer Specialists
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
Facility Name
Southwestern Vermont Health Care
City
Bennington
State/Province
Vermont
ZIP/Postal Code
05201
Country
United States
Facility Name
Danville Hematology and Oncology, Inc.
City
Danville
State/Province
Virginia
ZIP/Postal Code
24541
Country
United States
Facility Name
Northern Virginia Oncology Group
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
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
City
Portsmouth
State/Province
Virginia
ZIP/Postal Code
23704
Country
United States
Facility Name
Virginia Cancer Institute
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23230
Country
United States
Facility Name
Western Washington Medical Group
City
Everett
State/Province
Washington
ZIP/Postal Code
98201
Country
United States
Facility Name
Western Washington Medical Group
City
Everett
State/Province
Washington
ZIP/Postal Code
982901
Country
United States
Facility Name
Cascade Cancer Center
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98034
Country
United States
Facility Name
UW Health -- University of Wisconsin Comp
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
Waukesha Memorial Hospital
City
Waukesha
State/Province
Wisconsin
ZIP/Postal Code
53188
Country
United States
City
Adelaide
ZIP/Postal Code
SA 5000
Country
Australia
City
Garran
ZIP/Postal Code
ACT 2605
Country
Australia
City
Nedlands
ZIP/Postal Code
WS 6009
Country
Australia
City
Wollongong
ZIP/Postal Code
NSW 2500
Country
Australia
City
Woolloongabba
ZIP/Postal Code
QLD 4102
Country
Australia
City
Anderlecht
ZIP/Postal Code
1070
Country
Belgium
City
Antwerpen
ZIP/Postal Code
2020
Country
Belgium
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
City
Gent
ZIP/Postal Code
9000
Country
Belgium
City
Wilrijk
ZIP/Postal Code
2610
Country
Belgium
City
Porto Alegre RS
ZIP/Postal Code
90020-090
Country
Brazil
City
Porto Alegre
ZIP/Postal Code
CeP 90 610-000
Country
Brazil
City
Salvador
ZIP/Postal Code
BA 41825-010
Country
Brazil
City
Sao Paulo
ZIP/Postal Code
05651-901
Country
Brazil
City
Sao Paulo
ZIP/Postal Code
S01232-910
Country
Brazil
City
Sao Paulo
ZIP/Postal Code
S01308-050
Country
Brazil
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
Novartis Investigative Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
City
Toronto
State/Province
Ontario
Country
Canada
City
Sainte-Foy
State/Province
Quebec
Country
Canada
City
Brno
ZIP/Postal Code
656 53
Country
Czechia
City
Praha 2
ZIP/Postal Code
128 08
Country
Czechia
City
Praha 5
ZIP/Postal Code
150 18
Country
Czechia
City
Marseille cedex 05
ZIP/Postal Code
13385
Country
France
City
Marseille Cedex 9
ZIP/Postal Code
13273
Country
France
City
Strasbourg
ZIP/Postal Code
6700
Country
France
City
Augsburg
ZIP/Postal Code
86150
Country
Germany
City
Berlin
ZIP/Postal Code
13353
Country
Germany
City
Berlin
ZIP/Postal Code
14195
Country
Germany
City
Dessau
ZIP/Postal Code
6822
Country
Germany
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
City
Eschweiler
ZIP/Postal Code
52249
Country
Germany
City
Essen
ZIP/Postal Code
45122
Country
Germany
City
Frankfurt
ZIP/Postal Code
60488
Country
Germany
City
Hannover
ZIP/Postal Code
30625
Country
Germany
City
Heidelberg
ZIP/Postal Code
69115
Country
Germany
City
Kiel
ZIP/Postal Code
24116
Country
Germany
City
Köln
ZIP/Postal Code
50677
Country
Germany
City
Leipzig
ZIP/Postal Code
4103
Country
Germany
City
Magdeburg
ZIP/Postal Code
39002
Country
Germany
City
Budapest
ZIP/Postal Code
H-1032
Country
Hungary
City
Budapest
ZIP/Postal Code
H-1097
Country
Hungary
City
Gyor
ZIP/Postal Code
H-9002
Country
Hungary
City
Szeged
ZIP/Postal Code
H-6725
Country
Hungary
City
Forli
ZIP/Postal Code
47100
Country
Italy
City
Genova
ZIP/Postal Code
16132
Country
Italy
City
Milano
ZIP/Postal Code
20162
Country
Italy
City
Modena
ZIP/Postal Code
41100
Country
Italy
City
Roma
ZIP/Postal Code
135
Country
Italy
City
Roma
ZIP/Postal Code
144
Country
Italy
City
Rozzano
ZIP/Postal Code
20089
Country
Italy
City
Torino
ZIP/Postal Code
10126
Country
Italy
City
GA Utrecht
ZIP/Postal Code
3508
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Hamilton
Country
New Zealand
City
Palmerston North
Country
New Zealand
City
Coimbra
ZIP/Postal Code
3000-076
Country
Portugal
Facility Name
Novartis Investigative Site
City
Bratislava
ZIP/Postal Code
81250
Country
Slovakia
Facility Name
Novartis Investigative Site
City
Bratislava
ZIP/Postal Code
833 10
Country
Slovakia
Facility Name
Novartis Investigative Site
City
Kosice
ZIP/Postal Code
041 90
Country
Slovakia
Facility Name
Novartis Investigative Site
City
Zilina
ZIP/Postal Code
012 07
Country
Slovakia
City
Alicante
ZIP/Postal Code
3202
Country
Spain
City
Madrid
ZIP/Postal Code
28033
Country
Spain
City
Madrid
ZIP/Postal Code
28035
Country
Spain
City
Madrid
ZIP/Postal Code
28041
Country
Spain
City
Malaga
ZIP/Postal Code
29010
Country
Spain
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
City
Stockholm
ZIP/Postal Code
SE-118 83
Country
Sweden
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
City
Thun
ZIP/Postal Code
3600
Country
Switzerland
City
Zurich
ZIP/Postal Code
8027
Country
Switzerland
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland
City
Tainan
Country
Taiwan
City
Taipei
Country
Taiwan
City
Tao-Yuan
Country
Taiwan
City
Belfast
ZIP/Postal Code
BT9 7AB
Country
United Kingdom
City
Leicester
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
City
Oxford
ZIP/Postal Code
OX3 7LJ
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
21464406
Citation
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.
Results Reference
derived

Learn more about this trial

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

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