Clinical trial NCT00056446: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Colorectal Neoplasms
Colonic Neoplasms
Rectal Neoplasms
Keywords: Colorectal Cancer
Oxaliplatin
VEGF inhibitor
Vatalanib
PTK787
Colon Cancer
Colorectal Carcinoma
Rectal Cancer
Colorectal Tumor
Lead sponsor: Novartis
Sponsor class: INDUSTRY
Collaborators: name: Bayer
First posted: 2003-03-14
Enrollment: 855
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Overall survival
timeFrame: throughout duration of study
Secondary outcomes:
measure: Progression free survival
timeFrame: throughout duration of study
measure: Time to progression
timeFrame: throughout duration of study
measure: Time to treatment failure
timeFrame: throughout duration of study
measure: Tumor response rate
timeFrame: throughout duration of study
measure: Tolerability and safety profile
timeFrame: throughout duration of study
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Comprehensive Cancer Institute
state: Alabama
city: Anchorage
country: United States
facility: Alaska Oncology and Hematology
state: Alaska
city: Tucson
country: United States
facility: Arizona Clinical Research Center
state: Arizona
city: Jonesboro
country: United States
facility: Northeast Arkansas Clinic
state: Arkansas
city: Little Rock
country: United States
facility: Arkansas Cancer Research Center
state: Arkansas
city: Little Rock
country: United States
facility: Little Rock Hematology & Oncology
state: Arkansas
city: Springdale
country: United States
facility: Highlands Oncology Group
state: Arkansas
city: Bakersfield
country: United States
facility: Comprehensive Blood and Cancer Center
state: California
city: Burbank
country: United States
facility: Providence St. Joseph Medical Center
state: California
city: Fountain Valley
country: United States
facility: Compassionate Cancer Care Medical Group, Inc.
state: California
city: Fresno
country: United States
facility: California Oncology of the Central Valley
state: California
city: Fullerton
country: United States
facility: Virginia K. Crosson Cancer Center
state: California
city: Glendale
country: United States
facility: Glendale Adventist Medical Center
state: California
city: La Jolla
country: United States
facility: Scripps Green Hospital
state: California
city: La Verne
country: United States
facility: Wilshire Oncology Medical Group
state: California
city: Long Beach
country: United States
facility: Pacific Shores Medical Group
state: California
city: Los Angeles
country: United States
facility: USC Norris Cancer Center
state: California
city: Los Angeles
country: United States
facility: Synergy Hematology-Oncology Medical Associates
state: California
city: Los Angeles
country: United States
facility: Novartis Investigative Site
state: California
city: Los Angeles
country: United States
facility: UCLA School of Medicine
state: California
city: Monterey Park
country: United States
facility: Eddie Hong-Lung Hu, M.D.
state: California
city: Northridge
country: United States
facility: North Valley Hematology/Oncology Medical Group
state: California
city: Orange
country: United States
facility: Medical Oncology Care Associates
state: California
city: Oxnard
country: United States
facility: Ventura County Hematology-Oncology Specialists
state: California
city: Porterville
country: United States
facility: Sierra View District Hospital
state: California
city: Redondo Beach
country: United States
facility: Cancer Care Associates Medical Group, Inc.
state: California
city: San Jose
country: United States
facility: Santa Clara Valley Medical Center
state: California
city: Santa Barbara
country: United States
facility: Sansum Santa Barbara Foundation Medical Clinic
state: California
city: Santa Barbara
country: United States
facility: Santa Barbara Hematology Oncology Medical Group, Inc.
state: California
city: Vista
country: United States
facility: San Diego Cancer Center Medical Group
state: California
city: Denver
country: United States
facility: Mile High Oncology
state: Colorado
city: Denver
country: United States
facility: Rocky Mountain Cancer Center
state: Colorado
city: Manchester
country: United States
facility: Manchester Hematology/Oncology Assoc.
state: Connecticut
city: Washington
country: United States
facility: Washington Oncology/Hematology Center
state: District of Columbia
city: Boca Raton
country: United States
facility: The Center for Hematology and Oncology
state: Florida
city: Ft. Myers
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Lake Worth
country: United States
facility: Hematology Oncology Associates
state: Florida
city: Miami
country: United States
facility: University of Miami School of Medicine
state: Florida
city: Miami
country: United States
facility: Oncology/Hematology Group of South Florida
state: Florida
city: Port St. Lucie
country: United States
facility: Hematology Oncology Associates of Treasure Coast
state: Florida
city: Zephyrhills
country: United States
facility: Florida Medical Clinic
state: Florida
city: Marietta
country: United States
facility: Atlanta Cancer Care
state: Georgia
city: Savannah
country: United States
facility: Office of Research
state: Georgia
city: Savannah
country: United States
facility: Coastal Hematology & Oncology
state: Georgia
city: Thomasville
country: United States
facility: Lewis Hall Singletary Oncology Center
state: Georgia
city: Coeur d'Alene
country: United States
facility: North Idaho Cancer Center
state: Idaho
city: Chicago
country: United States
facility: University of Chicago medical Center, Hematology/Oncology
state: Illinois
city: Peoria
country: United States
facility: Oncology Hematology Associates of Central Illinois, PC
state: Illinois
city: Skokie
country: United States
facility: Northshore Cancer Research Association
state: Illinois
city: Skokie
country: United States
facility: Midwest Cancer Research Group
state: Illinois
city: Fort Wayne
country: United States
facility: Fort Wayne Medical Oncology & Hematology, Inc.
state: Indiana
city: Munster
country: United States
facility: Munster Community Hospital
state: Indiana
city: Topeka
country: United States
facility: Cotton O'Neil Oncology Clinic
state: Kansas
city: Louisville
country: United States
facility: Vijay Raghaven, M.D.
state: Kentucky
city: Owensboro
country: United States
facility: Owensboro Medical Health System
state: Kentucky
city: Alexandria
country: United States
facility: Cabrini Center for Cancer Care
state: Louisiana
city: New Orleans
country: United States
facility: LSU Medical Center
state: Louisiana
city: New Orleans
country: United States
facility: Tulane University Health Sciences Center
state: Louisiana
city: Shreveport
country: United States
facility: LSU Health Sciences Center
state: Louisiana
city: Scarborough
country: United States
facility: Maine Center for Cancer Medicine & Blood Disorders
state: Maine
city: Baltimore
country: United States
facility: St. Agnes Healthcare
state: Maryland
city: Baltimore
country: United States
facility: Franklin Square Hospital Center
state: Maryland
city: Rockville
country: United States
facility: Kaiser Permanente
state: Maryland
city: Worcester
country: United States
facility: Fallon Clinic at Worcester Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Grand Rapids
country: United States
facility: Spectrum Health -- Cook Research Dept.
state: Michigan
city: Southfield
country: United States
facility: Providence Cancer Center
state: Michigan
city: St. Joseph
country: United States
facility: Oncology Care Associates, PLLC
state: Michigan
city: Minneapolis
country: United States
facility: Minnesota CGOP
state: Minnesota
city: Kansas City
country: United States
facility: Heartland Hematology
state: Missouri
city: St. Charles
country: United States
facility: Missouri Cancer Care, PC
state: Missouri
city: St. Louis
country: United States
facility: Saint Louis University
state: Missouri
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: St. Louis
country: United States
facility: Missouri Baptist Cancer Center
state: Missouri
city: St. Louis
country: United States
facility: Arch Medical Services Incorporated
state: Missouri
city: Great Falls
country: United States
facility: North Central Montana Professional Building
state: Montana
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada
state: Nevada
city: Las Vegas
country: United States
facility: Nevada Cancer Center
state: Nevada
city: Hooksett
country: United States
facility: NH Oncology-Hematology, PA
state: New Hampshire
city: Cherry Hill
country: United States
facility: Center for Cancer and Hematologic Disease
state: New Jersey
city: Livingston
country: United States
facility: St. Barnabas Cancer Center
state: New Jersey
city: Morristown
country: United States
facility: Hematology Oncology Associates of Northern New Jersey
state: New Jersey
city: Voorhees
country: United States
facility: Cooper Cancer Center
state: New Jersey
city: Albuquerque
country: United States
facility: Hematology/Oncology Associates
state: New Mexico
city: Albuquerque
country: United States
facility: New Mexico Oncology/Hematology
state: New Mexico
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: East Syracuse
country: United States
facility: Hematology/Oncology Associates of Central NY
state: New York
city: Fresh Meadows
country: United States
facility: Queens Medical Associates, PC
state: New York
city: Glens Falls
country: United States
facility: Charles R. Wood Cancer Center
state: New York
city: Manhasset
country: United States
facility: North Shore University Hospital
state: New York
city: New York
country: United States
facility: St. Vincent's Catholic Medical Centers of New York
state: New York
city: Nyack
country: United States
facility: Hematology-Oncology Associates of Rockland
state: New York
city: Rochester
country: United States
facility: Pluta Cancer Center
state: New York
city: Rochester
country: United States
facility: James P. Wilmot Cancer Center
state: New York
city: Chapel Hill
country: United States
facility: Lineberger Comprehensive Cancer Center
state: North Carolina
city: Charlotte
country: United States
facility: Carolinas Hematology/Oncology Associates
state: North Carolina
city: Canton
country: United States
facility: Nashat Gabrail, M.D.
state: Ohio
city: Cleveland
country: United States
facility: Case Western Reserve University
state: Ohio
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
city: Columbus
country: United States
facility: Columbus CCOP
state: Ohio
city: Oklahoma City
country: United States
facility: The University of Oklahoma Health Sciences Center
state: Oklahoma
city: Tulsa
country: United States
facility: Oklahoma Oncology, Inc.
state: Oklahoma
city: Drexel Hill
country: United States
facility: Consultants in Medical Oncology & Hematology
state: Pennsylvania
city: Dunmore
country: United States
facility: Hematology & Oncology Associates of NE PA
state: Pennsylvania
city: Hershey
country: United States
facility: Penn State Hershey Medical Center
state: Pennsylvania
city: Monongahela
country: United States
facility: Monongahela Valley Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Cancer Pavillion
state: Pennsylvania
city: Charleston
country: United States
facility: Charleston Cancer Center
state: South Carolina
city: Columbia
country: United States
facility: South Carolina Oncology Associates
state: South Carolina
city: Columbia
country: United States
facility: WJB Dom VAMC
state: South Carolina
city: Greenville
country: United States
facility: Cancer Center of the Carolinas
state: South Carolina
city: Spartanburg
country: United States
facility: Spartanburg Regional Medical Center
state: South Carolina
city: Chattanooga
country: United States
facility: Erlanger Health System
state: Tennessee
city: Clarksville
country: United States
facility: Clarksville Regional Hematology/Oncology
state: Tennessee
city: Germantown
country: United States
facility: The Jones Clinic
state: Tennessee
city: Knoxville
country: United States
facility: Baptist Regional Cancer Center
state: Tennessee
city: Memphis
country: United States
facility: University of Tennessee Cancer Institute
state: Tennessee
city: Nashville
country: United States
facility: Sarah Cannon Cancer Center
state: Tennessee
city: Nashville
country: United States
facility: Meharry Medical College
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University School of Medicine
state: Tennessee
city: Amarillo
country: United States
facility: Harrington Cancer Center
state: Texas
city: Dallas
country: United States
facility: Center for Oncology Research & Treatment
state: Texas
city: Dallas
country: United States
facility: Clinical Hematology & Oncology
state: Texas
city: Houston
country: United States
facility: Oncology Consultants
state: Texas
city: Houston
country: United States
facility: H. Alejandro Preti, M.D., PA
state: Texas
city: Houston
country: United States
facility: M.D. Anderson Cancer Center
state: Texas
city: San Antonio
country: United States
facility: South Texas Oncology & Hematology
state: Texas
city: Temple
country: United States
facility: Scott & White Hospital
state: Texas
city: Ogden
country: United States
facility: Northern Utah Cancer Associates
state: Utah
city: Bennington
country: United States
facility: Southwestern Vermont Health Care
state: Vermont
city: Norfolk
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Portsmouth
country: United States
facility: Cancer Treatment Centers of America in Hampton Roads
state: Virginia
city: Everett
country: United States
facility: Western Washington Clinic
state: Washington
city: Kirkland
country: United States
facility: Cascade Cancer Center
state: Washington
city: Puyallup
country: United States
facility: Rainier Oncology
state: Washington
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
city: Seattle
country: United States
facility: Swedish Cancer Institute
state: Washington
city: Morgantown
country: United States
facility: West Virginia University Health Sciences Center
state: West Virginia
city: Waukesha
country: United States
facility: Waukesha Memorial Hospital
state: Wisconsin
city: West Bend
country: United States
facility: Kettle Morain Oncology
state: Wisconsin
city: Frankston
country: Australia
facility: Novartis Investigative Site
city: Woodville South
country: Australia
facility: Novartis Investigative Site
city: St. Veit an der Glan
country: Austria
facility: Novartis Investigative Site
city: Antwerpen
country: Belgium
facility: Novartis Investigative Site
city: Brasschaat
country: Belgium
facility: Novartis Investigative Site
city: Bruxelles
country: Belgium
facility: Novartis Investigative Site
city: Leuven
country: Belgium
facility: Novartis Investigative Site
city: Liège
country: Belgium
facility: Novartis Investigative Site
city: Wilrijk
country: Belgium
facility: Novartis Investigative Site
city: Porto Alegre RS
country: Brazil
facility: Novartis Investigative Site
city: Salvador - Ba
country: Brazil
facility: Novartis Investigative Site
city: Salvador, Bahia
country: Brazil
facility: Novartis Investigative Site
city: Sao Paulo
country: Brazil
facility: Novartis Investigative Site
city: Sao Paulo
country: Brazil
facility: Novartis Investigative Site
city: Sao Paulo
country: Brazil
facility: Novartis Investigative Site
city: Calgary
country: Canada
facility: Novartis Investigative Site
state: Alberta
city: Penticton
country: Canada
facility: Novartis Investigative Site
state: British Columbia
city: Winnepeg
country: Canada
facility: Novartis Investigative Site
state: Manitoba
city: Sydney
country: Canada
facility: Novartis Investigative Site
state: Nova Scotia
city: Barrie
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Brampton
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Hamilton
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Ottawa
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Sainte-Foy
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: St. Catharines
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Sudbury
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Thunder Bay
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Toronto
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Toronto
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Toronto
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Windsor
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Greenfield Park
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Montreal
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Montreal
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Saskatoon
country: Canada
facility: Novartis Investigative Site
state: Saskatchewan
city: Avignon
country: France
facility: Novartis Investigative Site
city: Boulogne Cedex
country: France
facility: Novartis Investigative Site
city: Lille cedex
country: France
facility: Novartis Investigative Site
city: Marseille cedex 05
country: France
facility: Novartis Investigative Site
city: Montpellier cedex 5
country: France
facility: Novartis Investigative Site
city: Nice cedex 2
country: France
facility: Novartis Investigative Site
city: Rennes cedex
country: France
facility: Novartis Investigative Site
city: Saint Herblain
country: France
facility: Novartis Investigative Site
city: Strasbourg
country: France
facility: Novartis Investigative Site
city: Toulouse cedex
country: France
facility: Novartis Investigative Site
city: Augsburg
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Bielefeld
country: Germany
facility: Novartis Investigative Site
city: Braunschweig
country: Germany
facility: Novartis Investigative Site
city: Dessau
country: Germany
facility: Novartis Investigative Site
city: Dresden
country: Germany
facility: Novartis Investigative Site
city: Essen
country: Germany
facility: Novartis Investigative Site
city: Essen
country: Germany
facility: Novartis Investigative Site
city: Frankfurt
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Hannover
country: Germany
facility: Novartis Investigative Site
city: Köln
country: Germany
facility: Novartis Investigative Site
city: Magdeburg
country: Germany
facility: Novartis Investigative Site
city: München
country: Germany
facility: Novartis Investigative Site
city: Neumünster
country: Germany
facility: Novartis Investigative Site
city: Trier
country: Germany
facility: Novartis Investigative Site
city: Ulm
country: Germany
facility: Novartis Investigative Site
city: Wiesbaden
country: Germany
facility: Novartis Investigative Site
city: ChaiWan
country: Hong Kong
facility: Novartis Investigative Site
city: Ancona
country: Italy
facility: Novartis Investigative Site
city: Bergamo
country: Italy
facility: Novartis Investigative Site
city: Brescia
country: Italy
facility: Novartis Investigative Site
city: Cremona
country: Italy
facility: Novartis Investigative Site
city: Genova
country: Italy
facility: Novartis Investigative Site
city: Livorno
country: Italy
facility: Novartis Investigative Site
city: Milano
country: Italy
facility: Novartis Investigative Site
city: Milano
country: Italy
facility: Novartis Investigative Site
city: Reggio Emilia
country: Italy
facility: Novartis Investigative Site
city: Roma
country: Italy
facility: Novartis Investigative Site
city: Roma
country: Italy
facility: Novartis Investigative Site
city: Rozzano
country: Italy
facility: Novartis Investigative Site
city: Auckland
country: New Zealand
facility: Novartis Investigative Site
city: Christchurch
country: New Zealand
facility: Novartis Investigative Site
city: Wellington
country: New Zealand
facility: Novartis Investigative Site
city: Coimbra
country: Portugal
facility: Novartis Investigative Site
city: Lisboa
country: Portugal
facility: Novartis Investigative Site
city: Bratislava
country: Slovakia
facility: Novartis Investigative Site
city: Cordoba
country: Spain
facility: Novartis Investigative Site
city: Elche
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Malaga
country: Spain
facility: Novartis Investigative Site
city: Zaragoza
country: Spain
facility: Novartis Investigative Site
city: Goteborg
country: Sweden
facility: Novartis Investigative Site
city: Stockholm
country: Sweden
facility: Novartis Investigative Site
city: Bern
country: Switzerland
facility: Novartis Investigative Site
city: Thun
country: Switzerland
facility: Novartis Investigative Site
city: Changhua
country: Taiwan
facility: Novartis Investigative Site
city: Kaohsiung
country: Taiwan
facility: Novartis Investigative Site
city: Keelung
country: Taiwan
facility: Novartis Investigative Site
city: Taichung
country: Taiwan
facility: Novartis Investigative Site
city: Tainan
country: Taiwan
facility: Novartis Investigative Site
city: Taipei
country: Taiwan
facility: Novartis Investigative Site
city: Tao-Yuan
country: Taiwan
facility: Novartis Investigative Site
city: Belfast
country: United Kingdom
facility: Novartis Investigative Site
city: Birmingham
country: United Kingdom
facility: Novartis Investigative Site
city: Cardiff
country: United Kingdom
facility: Novartis Investigative Site
city: London
country: United Kingdom
facility: Novartis Investigative Site
city: Manchester
country: United Kingdom
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis / Schering AG Germany
name: Novartis/Schering AG, Germany
role: STUDY_CHAIR
References:
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.