Study of Oxaliplatin/5-FU/Leucovorin Plus Vatalanib Versus Oxaliplatin/5-FU/Leucovorin in Patients With Metastatic Colorectal Cancer.
A Randomized, Double-blind, Placebo-controlled, Phase Lll Study in Patients With Metastatic Adenocarcinoma of the Colon or Rectum Who Are Receiving First-line Chemotherapy With Oxaliplatin/5-fluorouracil/Leucovorin With PTK787/ZK 222584 or Placebo
2 other identifiers
interventional
1,168
19 countries
223
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
223 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2003
CompletedFirst Submitted
Initial submission to the registry
March 13, 2003
CompletedFirst Posted
Study publicly available on registry
March 14, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2007
CompletedFebruary 10, 2020
February 1, 2020
3.9 years
March 13, 2003
February 6, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression free survival
Throughout duration of study
Secondary Outcomes (4)
Time to progression
Throughout duration of study
Time to treatment failure
Throughout duration of study
Best overall response rate
Throughout duration of study
Tolerability and safety profile
Throughout duration of study
Study Arms (2)
1
EXPERIMENTALOxaliplatin/5-FU/LV and PTK787/ZK 222584
2
PLACEBO COMPARATOROxaliplatin/5-FU/LV and placebo
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (223)
Alabama Hematology/Oncology
Birmingham, Alabama, 35243, United States
Palo Verde Hematology & Oncology
Glendale, Arizona, 85304, United States
Arizona Cancer Center
Tucson, Arizona, 85724, United States
Northeast Arkansas Clinic
Jonesboro, Arkansas, 72401, United States
Highlands Oncology Group
Springdale, Arkansas, 72764, United States
Comprehensive Blood and Cancer Center
Bakersfield, California, 93309, United States
Providence St. Joseph Medical Center
Burbank, California, 91505, United States
Compassionate Cancer Care Medical Group, Inc
Fountain Valley, California, 92708, United States
California Oncology of the Central Valley
Fresno, California, 93710, United States
Virginia K. Crosson Cancer Center
Fullerton, California, 92835, United States
Ronald Yanagiharaa, M.D.
Gilroy, California, 95020, United States
Glendale Adventist Medical Center Cancer Center
Glendale, California, 91206, United States
Pacific Shores Medical Group
Long Beach, California, 90813, United States
Cancer Institute Medical Group
Los Angeles, California, 90025, United States
USC/Norris Comprehensive Cancer Care Center
Los Angeles, California, 90033, United States
Synergy Hematology-Oncology Medical Associates
Los Angeles, California, 90057, United States
UCLA School of Medicine
Los Angeles, California, 90095, United States
Eddie Hong-Lung Hu, M.D.
Monterey Park, California, 91754, United States
North Valley Hematology/Oncology Medical Group
Northridge, California, 91328, United States
Ventura County Hematology-Oncology Specialists
Oxnard, California, 93030, United States
Wilshire Oncology Medical Group
Pomona, California, 91767, United States
Sierra View District Hospital
Porterville, California, 93257, United States
The Lucy Curci Cancer Center
Rancho Mirage, California, 92270, United States
Cancer Care Associates Medical Group, Inc.
Redondo Beach, California, 90277, United States
Pacific Hematology Oncology Associates
San Francisco, California, 94904, United States
Santa Clara Valley Medical Center
San Jose, California, 95128, United States
Sansum Santa Barbara Foundation Medical Clinic
Santa Barbara, California, 93105, United States
Santa Barbara Hematology Oncology Medical Group, Inc.
Santa Barbara, California, 93105, United States
San Diego Cancer Center Medical Group
Vista, California, 92083, United States
Colorado Cancer Research Program
Denver, Colorado, 80224, United States
Jennifer Caskey, M.D.
Wheat Ridge, Colorado, 08833, United States
Davis, Posteraro and Wasser, MD's, LLP
Manchester, Connecticut, 06040, United States
Connecticut Oncology Group
Middletown, Connecticut, 06457, United States
Medical Oncology Hematology Consultants
Newark, Delaware, 19808, United States
Washington Oncology-Hematology Center
Washington D.C., District of Columbia, 20016, United States
George Washington University Medical Center
Washington D.C., District of Columbia, 20037, United States
Boca Raton Comprehensive Cancer Center
Boca Raton, Florida, 33486, United States
Florida Cancer Specialists
Fort Myers, Florida, 33901, United States
Memorial Healthcare System
Hollywood, Florida, 33021, United States
Florida Oncology Associates
Jacksonville, Florida, 32204, United States
Lakeland Regional Cancer Center
Lakeland, Florida, 33803, United States
Oncology Hematology Group of South Florida
Miami, Florida, 33176, United States
Innovative Medical Research of South Florida
Miami Shores, Florida, 33138, United States
Hematology Oncology Associates of Treasure
Port Saint Lucie, Florida, 34952, United States
Florida Medical Clinic, PA
Zephyrhills, Florida, 33542, United States
Peachtree Hematology and Oncology
Atlanta, Georgia, 40202, United States
Coastal Hematology & Oncology
Savannah, Georgia, 31406, United States
North Idaho Cancer Center
Coeur d'Alene, Idaho, 83814, United States
Shelby D. Rifkin, M.D.
Arlington Heights, Illinois, 60004, United States
Monroe Medical Associates
Harvey, Illinois, 60426, United States
Oncology Hematology Associates of Central Illinois, PC
Peoria, Illinois, 61602, United States
Northshore Cancer Research Association
Skokie, Illinois, 60076, United States
Midwest Cancer Research Group
Skokie, Illinois, 60077, United States
Hematology-Oncology of Indiana, PC
Indianapolis, Indiana, 46260, United States
Associated Physicians & Surgeons Clinic, L.L.C.
Terre Haute, Indiana, 47804, United States
Markey Clinical Oncology Research Program
Lexington, Kentucky, 40536-0098, United States
Norton Healthcare Pavilion
Louisville, Kentucky, 40202, United States
Vijay Raghavan, M.D.
Louisville, Kentucky, 40215, United States
Louisiana Oncology Associates
Lafayette, Louisiana, 70506, United States
LSU Medical Center
New Orleans, Louisiana, 70112, United States
Tulane University Health Sciences Center
New Orleans, Louisiana, 70112, United States
LSU Health Sciences Center
Shreveport, Louisiana, 71130-3932, United States
Maine Center for Cancer Medicine & Blood Disorders
Scarborough, Maine, 04074, United States
St. Agnes Healthcare, Inc.
Baltimore, Maryland, 21229-5299, United States
Kaiser Permanente
Rockville, Maryland, 20850, United States
St. Joseph Mercy Hospital
Ann Arbor, Michigan, 48106-0995, United States
Josephine Ford Cancer Center
Detroit, Michigan, 48202, United States
Genesys Hurley Cancer Institute
Flint, Michigan, 48503, United States
Spectrum Health -- Cook Research Dept.
Grand Rapids, Michigan, 49503, United States
Hematology and Oncology Assoc. of Southern Mississippi
Jackson, Michigan, 48201, United States
Oncology Care Associates, PLLC
Saint Joseph, Michigan, 49085, United States
Providence Cancer Center
Southfield, Michigan, 48075, United States
SMDC Health System
Duluth, Minnesota, 55805, United States
Minnesota CGOP
Minneapolis, Minnesota, 55407, United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455, United States
Metro Minnesota CCOP
Saint Louis Park, Minnesota, 55426, United States
Heartland Hematology/Oncology Associates, Inc.
Kansas City, Missouri, 64118, United States
Kansas City Oncology and Hematology Group
Kansas City, Missouri, 64131, United States
Missouri Cancer Care, PC
Saint Charles, Missouri, 63301, United States
Saint Louis University
St Louis, Missouri, 63110, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Missouri Baptist Cancer Center
St Louis, Missouri, 63131, United States
Arch Medical Services Incorporated
St Louis, Missouri, 63141, United States
North Central Montana Professional Building
Great Falls, Montana, 59405, United States
Montana Cancer Specialists
Missoula, Montana, 59807-7877, United States
The Methodist Cancer Center
Omaha, Nebraska, 68114, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89109, United States
Nevada Cancer Center
Las Vegas, Nevada, 89109, United States
The Center for Cancer and Hematologic Disease
Cherry Hill, New Jersey, 08003, United States
St. Barnabas Cancer Center
Livingston, New Jersey, 07039, United States
Hematology-Oncology Associates of New Jersey
Morristown, New Jersey, 07960, United States
Southern Oncology and Hematology Associates
Vineland, New Jersey, 08360, United States
Cooper Cancer Institute
Voorhees Township, New Jersey, 08043, United States
New Mexico Cancer Care
Santa Fe, New Mexico, 87505, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
CR Wood Cancer Center
Glens Falls, New York, 12801, United States
Cancer Research of Long Island
Great Neck, New York, 11023, United States
Broome Oncology
Johnson City, New York, 13790, United States
New York Oncology Hematology
Latham, New York, 12110, United States
North Shore University Hospital
Manhasset, New York, 11030, United States
Cancer Center at Nyack Hospital
Nyack, New York, 10960, United States
Pluta Cancer Center
Rochester, New York, 14623, United States
Carolina Medical Center
Charlotte, North Carolina, 28203, United States
Mid-Dakota Clinic PC
Bismarck, North Dakota, 58501, United States
Nashat Gabrail, M.D.
Canton, Ohio, 44718, United States
Mid Ohio Oncology/Hematology, Inc.
Columbus, Ohio, 43213, United States
Hematology Oncology Consultants, Inc.
Columbus, Ohio, 43235, United States
Meridia Cancer Institute
Mayfield Heights, Ohio, 44124, United States
Cancer Care Associates
Oklahoma City, Oklahoma, 73112, United States
Cancer Care Associates
Tulsa, Oklahoma, 74136-1929, United States
Kaiser Permanente Oncology Hematology
Portland, Oregon, 97227, United States
Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Monogahela Valley Hospital
Monongahela, Pennsylvania, 15063, United States
University of Pennsylvania Abramson Cancer Center
Philadelphia, Pennsylvania, 19104, United States
Allegheny Cancer Center
Pittsburgh, Pennsylvania, 15212-4772, United States
Charleston Hematology Oncology
Charleston, South Carolina, 29403, United States
Charleston Cancer Center
Charleston, South Carolina, 29406, United States
South Carolina Oncology Associates
Columbia, South Carolina, 29201, United States
Cancer Center of the Carolinas
Greenville, South Carolina, 29615, United States
Spartanburg Regional Medical Center
Spartanburg, South Carolina, 29303, United States
The Jones Clinic
Germantown, Tennessee, 38138, United States
Baptist Regional Cancer Center
Knoxville, Tennessee, 37920, United States
University of Tennessee Cancer Institute
Memphis, Tennessee, 38104, United States
Sarah Cannon Cancer Center
Nashville, Tennessee, 37203, United States
Southwest Regional Cancer Center
Austin, Texas, 78705, United States
Corpus Christi Cancer Center
Corpus Christi, Texas, 78412, United States
Center for Oncology Research & Treatment, PA
Dallas, Texas, 75230, United States
Oncology Consultants
Houston, Texas, 77024, United States
H. Alejandro Preti, MD, PA
Houston, Texas, 77030, United States
M.D. Anderson Cancer Center
Houston, Texas, 77030, United States
Dr. Lee C. Drinkard
Irving, Texas, 75038, United States
Scott & White Hospital
Temple, Texas, 76508, United States
North Utah Associates
Ogden, Utah, 84403-3105, United States
Utah Cancer Specialists
Salt Lake City, Utah, 84124, United States
Southwestern Vermont Health Care
Bennington, Vermont, 05201, United States
Danville Hematology and Oncology, Inc.
Danville, Virginia, 24541, United States
Northern Virginia Oncology Group
Fairfax, Virginia, 22031, United States
Virginia Oncology Associates
Norfolk, Virginia, 23502, United States
Cancer Treatment Centers of America
Portsmouth, Virginia, 23704, United States
Virginia Cancer Institute
Richmond, Virginia, 23230, United States
Western Washington Medical Group
Everett, Washington, 98201, United States
Western Washington Medical Group
Everett, Washington, 982901, United States
Cascade Cancer Center
Kirkland, Washington, 98034, United States
UW Health -- University of Wisconsin Comp
Madison, Wisconsin, 53792, United States
Waukesha Memorial Hospital
Waukesha, Wisconsin, 53188, United States
Unknown Facility
Adelaide, SA 5000, Australia
Unknown Facility
Garran, ACT 2605, Australia
Unknown Facility
Nedlands, WS 6009, Australia
Unknown Facility
Wollongong, NSW 2500, Australia
Unknown Facility
Woolloongabba, QLD 4102, Australia
Unknown Facility
Anderlecht, 1070, Belgium
Unknown Facility
Antwerp, 2020, Belgium
Unknown Facility
Brussels, 1200, Belgium
Unknown Facility
Ghent, 9000, Belgium
Unknown Facility
Wilrijk, 2610, Belgium
Unknown Facility
Porto Alegre, CeP 90 610-000, Brazil
Unknown Facility
Porto Alegre RS, 90020-090, Brazil
Unknown Facility
Salvador, BA 41825-010, Brazil
Unknown Facility
São Paulo, 05651-901, Brazil
Unknown Facility
São Paulo, S01232-910, Brazil
Unknown Facility
São Paulo, S01308-050, Brazil
Unknown Facility
Hamilton, Ontario, Canada
Novartis Investigative Site
Toronto, Ontario, M5G 2M9, Canada
Unknown Facility
Toronto, Ontario, Canada
Unknown Facility
Sainte-Foy, Quebec, Canada
Unknown Facility
Brno, 656 53, Czechia
Unknown Facility
Prague, 128 08, Czechia
Unknown Facility
Prague, 150 18, Czechia
Unknown Facility
Marseille, 13273, France
Unknown Facility
Marseille, 13385, France
Unknown Facility
Strasbourg, 6700, France
Unknown Facility
Augsburg, 86150, Germany
Unknown Facility
Berlin, 13353, Germany
Unknown Facility
Berlin, 14195, Germany
Unknown Facility
Cologne, 50677, Germany
Unknown Facility
Dessau, 6822, Germany
Unknown Facility
Erlangen, 91054, Germany
Unknown Facility
Eschweiler, 52249, Germany
Unknown Facility
Essen, 45122, Germany
Unknown Facility
Frankfurt, 60488, Germany
Unknown Facility
Hanover, 30625, Germany
Unknown Facility
Heidelberg, 69115, Germany
Unknown Facility
Kiel, 24116, Germany
Unknown Facility
Leipzig, 4103, Germany
Unknown Facility
Magdeburg, 39002, Germany
Unknown Facility
Budapest, H-1032, Hungary
Unknown Facility
Budapest, H-1097, Hungary
Unknown Facility
Győr, H-9002, Hungary
Unknown Facility
Szeged, H-6725, Hungary
Unknown Facility
Forlì, 47100, Italy
Unknown Facility
Genova, 16132, Italy
Unknown Facility
Milan, 20162, Italy
Unknown Facility
Modena, 41100, Italy
Unknown Facility
Roma, 135, Italy
Unknown Facility
Roma, 144, Italy
Unknown Facility
Rozzano, 20089, Italy
Unknown Facility
Torino, 10126, Italy
Unknown Facility
GA Utrecht, 3508, Netherlands
Novartis Investigative Site
Hamilton, New Zealand
Unknown Facility
Palmerston North, New Zealand
Unknown Facility
Coimbra, 3000-076, Portugal
Novartis Investigative Site
Bratislava, 81250, Slovakia
Novartis Investigative Site
Bratislava, 833 10, Slovakia
Novartis Investigative Site
Košice, 041 90, Slovakia
Novartis Investigative Site
Žilina, 012 07, Slovakia
Unknown Facility
Alicante, 3202, Spain
Unknown Facility
Madrid, 28033, Spain
Unknown Facility
Madrid, 28035, Spain
Unknown Facility
Madrid, 28041, Spain
Unknown Facility
Málaga, 29010, Spain
Unknown Facility
Zaragoza, 50009, Spain
Unknown Facility
Stockholm, SE-118 83, Sweden
Unknown Facility
Basel, 4031, Switzerland
Unknown Facility
Bern, 3010, Switzerland
Unknown Facility
Thun, 3600, Switzerland
Unknown Facility
Zurich, 8027, Switzerland
Unknown Facility
Zurich, 8091, Switzerland
Unknown Facility
Tainan, Taiwan
Unknown Facility
Taipei, Taiwan
Unknown Facility
Taoyuan District, Taiwan
Unknown Facility
Belfast, BT9 7AB, United Kingdom
Unknown Facility
Leicester, LE1 5WW, United Kingdom
Unknown Facility
Oxford, OX3 7LJ, United Kingdom
Related Publications (1)
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.
PMID: 21464406DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Novartis / Schering AG, Germany
Novartis / Schering AG, Germany
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 13, 2003
First Posted
March 14, 2003
Study Start
February 1, 2003
Primary Completion
January 1, 2007
Last Updated
February 10, 2020
Record last verified: 2020-02