Clinical trial NCT00056459: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Colorectal Neoplasms
Colonic Neoplasms
Rectal Neoplasms
Keywords: Colorectal Cancer
PTK787
Vatalanib
VEGF inhibitor
Oxaliplatin
Angiogenesis
Rectal Cancer
Colon Cancer
Colorectal Carcinoma
Colorectal Tumor
Lead sponsor: Novartis
Sponsor class: INDUSTRY
Collaborators: name: Bayer
First posted: 2003-03-14
Enrollment: 1168
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: 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


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

Primary outcomes:
measure: Progression free survival
timeFrame: Throughout duration of study
Secondary outcomes:
measure: Time to progression
timeFrame: Throughout duration of study
measure: Time to treatment failure
timeFrame: Throughout duration of study
measure: Best overall response rate
timeFrame: Throughout duration of study
measure: Tolerability and safety profile
timeFrame: Throughout duration of study
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama Hematology/Oncology
state: Alabama
city: Glendale
country: United States
facility: Palo Verde Hematology & Oncology
state: Arizona
city: Tucson
country: United States
facility: Arizona Cancer Center
state: Arizona
city: Jonesboro
country: United States
facility: Northeast Arkansas Clinic
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: Gilroy
country: United States
facility: Ronald Yanagiharaa, M.D.
state: California
city: Glendale
country: United States
facility: Glendale Adventist Medical Center Cancer Center
state: California
city: Long Beach
country: United States
facility: Pacific Shores Medical Group
state: California
city: Los Angeles
country: United States
facility: Cancer Institute Medical Group
state: California
city: Los Angeles
country: United States
facility: USC/Norris Comprehensive Cancer Care Center
state: California
city: Los Angeles
country: United States
facility: Synergy Hematology-Oncology Medical Associates
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: Oxnard
country: United States
facility: Ventura County Hematology-Oncology Specialists
state: California
city: Pomona
country: United States
facility: Wilshire Oncology Medical Group
state: California
city: Porterville
country: United States
facility: Sierra View District Hospital
state: California
city: Rancho Mirage
country: United States
facility: The Lucy Curci Cancer Center
state: California
city: Redondo Beach
country: United States
facility: Cancer Care Associates Medical Group, Inc.
state: California
city: San Francisco
country: United States
facility: Pacific Hematology Oncology Associates
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: Colorado Cancer Research Program
state: Colorado
city: Wheat Ridge
country: United States
facility: Jennifer Caskey, M.D.
state: Colorado
city: Manchester
country: United States
facility: Davis, Posteraro and Wasser, MD's, LLP
state: Connecticut
city: Middletown
country: United States
facility: Connecticut Oncology Group
state: Connecticut
city: Newark
country: United States
facility: Medical Oncology Hematology Consultants
state: Delaware
city: Washington
country: United States
facility: Washington Oncology-Hematology Center
state: District of Columbia
city: Washington
country: United States
facility: George Washington University Medical Center
state: District of Columbia
city: Boca Raton
country: United States
facility: Boca Raton Comprehensive Cancer Center
state: Florida
city: Fort Myers
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Hollywood
country: United States
facility: Memorial Healthcare System
state: Florida
city: Jacksonville
country: United States
facility: Florida Oncology Associates
state: Florida
city: Lakeland
country: United States
facility: Lakeland Regional Cancer Center
state: Florida
city: Miami Shores
country: United States
facility: Innovative Medical Research of South Florida
state: Florida
city: Miami
country: United States
facility: Oncology Hematology Group of South Florida
state: Florida
city: Port Saint Lucie
country: United States
facility: Hematology Oncology Associates of Treasure
state: Florida
city: Zephyrhills
country: United States
facility: Florida Medical Clinic, PA
state: Florida
city: Atlanta
country: United States
facility: Peachtree Hematology and Oncology
state: Georgia
city: Savannah
country: United States
facility: Coastal Hematology & Oncology
state: Georgia
city: Coeur d'Alene
country: United States
facility: North Idaho Cancer Center
state: Idaho
city: Arlington Heights
country: United States
facility: Shelby D. Rifkin, M.D.
state: Illinois
city: Harvey
country: United States
facility: Monroe Medical Associates
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: Indianapolis
country: United States
facility: Hematology-Oncology of Indiana, PC
state: Indiana
city: Terre Haute
country: United States
facility: Associated Physicians & Surgeons Clinic, L.L.C.
state: Indiana
city: Lexington
country: United States
facility: Markey Clinical Oncology Research Program
state: Kentucky
city: Louisville
country: United States
facility: Norton Healthcare Pavilion
state: Kentucky
city: Louisville
country: United States
facility: Vijay Raghavan, M.D.
state: Kentucky
city: Lafayette
country: United States
facility: Louisiana Oncology Associates
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, Inc.
state: Maryland
city: Rockville
country: United States
facility: Kaiser Permanente
state: Maryland
city: Ann Arbor
country: United States
facility: St. Joseph Mercy Hospital
state: Michigan
city: Detroit
country: United States
facility: Josephine Ford Cancer Center
state: Michigan
city: Flint
country: United States
facility: Genesys Hurley Cancer Institute
state: Michigan
city: Grand Rapids
country: United States
facility: Spectrum Health -- Cook Research Dept.
state: Michigan
city: Jackson
country: United States
facility: Hematology and Oncology Assoc. of Southern Mississippi
state: Michigan
city: Saint Joseph
country: United States
facility: Oncology Care Associates, PLLC
state: Michigan
city: Southfield
country: United States
facility: Providence Cancer Center
state: Michigan
city: Duluth
country: United States
facility: SMDC Health System
state: Minnesota
city: Minneapolis
country: United States
facility: Minnesota CGOP
state: Minnesota
city: Minneapolis
country: United States
facility: University of Minnesota Cancer Center
state: Minnesota
city: Saint Louis Park
country: United States
facility: Metro Minnesota CCOP
state: Minnesota
city: Kansas City
country: United States
facility: Heartland Hematology/Oncology Associates, Inc.
state: Missouri
city: Kansas City
country: United States
facility: Kansas City Oncology and Hematology Group
state: Missouri
city: Saint Charles
country: United States
facility: Missouri Cancer Care, PC
state: Missouri
city: Saint Louis
country: United States
facility: Saint Louis University
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Saint Louis
country: United States
facility: Missouri Baptist Cancer Center
state: Missouri
city: Saint 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: Missoula
country: United States
facility: Montana Cancer Specialists
state: Montana
city: Omaha
country: United States
facility: The Methodist Cancer Center
state: Nebraska
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: Cherry Hill
country: United States
facility: The 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 New Jersey
state: New Jersey
city: Vineland
country: United States
facility: Southern Oncology and Hematology Associates
state: New Jersey
city: Voorhees
country: United States
facility: Cooper Cancer Institute
state: New Jersey
city: Santa Fe
country: United States
facility: New Mexico Cancer Care
state: New Mexico
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: Glens Falls
country: United States
facility: CR Wood Cancer Center
state: New York
city: Great Neck
country: United States
facility: Cancer Research of Long Island
state: New York
city: Johnson City
country: United States
facility: Broome Oncology
state: New York
city: Latham
country: United States
facility: New York Oncology Hematology
state: New York
city: Manhasset
country: United States
facility: North Shore University Hospital
state: New York
city: Nyack
country: United States
facility: Cancer Center at Nyack Hospital
state: New York
city: Rochester
country: United States
facility: Pluta Cancer Center
state: New York
city: Charlotte
country: United States
facility: Carolina Medical Center
state: North Carolina
city: Bismarck
country: United States
facility: Mid-Dakota Clinic PC
state: North Dakota
city: Canton
country: United States
facility: Nashat Gabrail, M.D.
state: Ohio
city: Columbus
country: United States
facility: Mid Ohio Oncology/Hematology, Inc.
state: Ohio
city: Columbus
country: United States
facility: Hematology Oncology Consultants, Inc.
state: Ohio
city: Mayfield Heights
country: United States
facility: Meridia Cancer Institute
state: Ohio
city: Oklahoma City
country: United States
facility: Cancer Care Associates
state: Oklahoma
city: Tulsa
country: United States
facility: Cancer Care Associates
state: Oklahoma
city: Portland
country: United States
facility: Kaiser Permanente Oncology Hematology
state: Oregon
city: Hershey
country: United States
facility: Hershey Medical Center
state: Pennsylvania
city: Monongahela
country: United States
facility: Monogahela Valley Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania Abramson Cancer Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny Cancer Center
state: Pennsylvania
city: Charleston
country: United States
facility: Charleston Hematology Oncology
state: South Carolina
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: 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: 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: Austin
country: United States
facility: Southwest Regional Cancer Center
state: Texas
city: Corpus Christi
country: United States
facility: Corpus Christi Cancer Center
state: Texas
city: Dallas
country: United States
facility: Center for Oncology Research & Treatment, PA
state: Texas
city: Houston
country: United States
facility: Oncology Consultants
state: Texas
city: Houston
country: United States
facility: H. Alejandro Preti, MD, PA
state: Texas
city: Houston
country: United States
facility: M.D. Anderson Cancer Center
state: Texas
city: Irving
country: United States
facility: Dr. Lee C. Drinkard
state: Texas
city: Temple
country: United States
facility: Scott & White Hospital
state: Texas
city: Ogden
country: United States
facility: North Utah Associates
state: Utah
city: Salt Lake City
country: United States
facility: Utah Cancer Specialists
state: Utah
city: Bennington
country: United States
facility: Southwestern Vermont Health Care
state: Vermont
city: Danville
country: United States
facility: Danville Hematology and Oncology, Inc.
state: Virginia
city: Fairfax
country: United States
facility: Northern Virginia Oncology Group
state: Virginia
city: Norfolk
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Portsmouth
country: United States
facility: Cancer Treatment Centers of America
state: Virginia
city: Richmond
country: United States
facility: Virginia Cancer Institute
state: Virginia
city: Everett
country: United States
facility: Western Washington Medical Group
state: Washington
city: Everett
country: United States
facility: Western Washington Medical Group
state: Washington
city: Kirkland
country: United States
facility: Cascade Cancer Center
state: Washington
city: Madison
country: United States
facility: UW Health -- University of Wisconsin Comp
state: Wisconsin
city: Waukesha
country: United States
facility: Waukesha Memorial Hospital
state: Wisconsin
city: Adelaide
country: Australia
city: Garran
country: Australia
city: Nedlands
country: Australia
city: Wollongong
country: Australia
city: Woolloongabba
country: Australia
city: Anderlecht
country: Belgium
city: Antwerpen
country: Belgium
city: Bruxelles
country: Belgium
city: Gent
country: Belgium
city: Wilrijk
country: Belgium
city: Porto Alegre RS
country: Brazil
city: Porto Alegre
country: Brazil
city: Salvador
country: Brazil
city: Sao Paulo
country: Brazil
city: Sao Paulo
country: Brazil
city: Sao Paulo
country: Brazil
city: Hamilton
country: Canada
state: Ontario
city: Toronto
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Sainte-Foy
country: Canada
state: Quebec
city: Brno
country: Czechia
city: Praha 2
country: Czechia
city: Praha 5
country: Czechia
city: Marseille cedex 05
country: France
city: Marseille Cedex 9
country: France
city: Strasbourg
country: France
city: Augsburg
country: Germany
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Dessau
country: Germany
city: Erlangen
country: Germany
city: Eschweiler
country: Germany
city: Essen
country: Germany
city: Frankfurt
country: Germany
city: Hannover
country: Germany
city: Heidelberg
country: Germany
city: Kiel
country: Germany
city: Köln
country: Germany
city: Leipzig
country: Germany
city: Magdeburg
country: Germany
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Gyor
country: Hungary
city: Szeged
country: Hungary
city: Forli
country: Italy
city: Genova
country: Italy
city: Milano
country: Italy
city: Modena
country: Italy
city: Roma
country: Italy
city: Roma
country: Italy
city: Rozzano
country: Italy
city: Torino
country: Italy
city: GA Utrecht
country: Netherlands
city: Hamilton
country: New Zealand
facility: Novartis Investigative Site
city: Palmerston North
country: New Zealand
city: Coimbra
country: Portugal
city: Bratislava
country: Slovakia
facility: Novartis Investigative Site
city: Bratislava
country: Slovakia
facility: Novartis Investigative Site
city: Kosice
country: Slovakia
facility: Novartis Investigative Site
city: Zilina
country: Slovakia
facility: Novartis Investigative Site
city: Alicante
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Malaga
country: Spain
city: Zaragoza
country: Spain
city: Stockholm
country: Sweden
city: Basel
country: Switzerland
city: Bern
country: Switzerland
city: Thun
country: Switzerland
city: Zurich
country: Switzerland
city: Zürich
country: Switzerland
city: Tainan
country: Taiwan
city: Taipei
country: Taiwan
city: Tao-Yuan
country: Taiwan
city: Belfast
country: United Kingdom
city: Leicester
country: United Kingdom
city: Oxford
country: United Kingdom
Study officials:
affiliation: Novartis / Schering AG, Germany
name: Novartis / Schering AG, Germany
role: STUDY_CHAIR
References:
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.