To compare treatment with oxaliplatin/5-FU/leucovorin plus PTK787/ZK 222584 versus oxaliplatin/5-FU/leucovorin plus placebo in patients with colorectal cancer that has spread to other organs and are seeking first chemotherapy treatment

Condition	Treatment or Intervention	Phase
Colorectal Neoplasms Colonic Neoplasms Rectal Neoplasms	Drug: PTK787/ZK 222584	Phase III

Further Study Details: 

Expected Total Enrollment:  1090

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion criteria

• Patients with metastatic colorectal cancer coming for first-line 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 with confirmed HIV infection
• Patients who are taking Coumadin

Alabama
      Alabama Hematology/Oncology, Birmingham,  Alabama,  35243,  United States
Arizona
      Arizona Cancer Center, Tucson,  Arizona,  85724,  United States
      Palo Verde Hematology & Oncology, Glendale,  Arizona,  85304,  United States
Arkansas
      Highlands Oncology Group, Springdale,  Arkansas,  72764,  United States
      Northeast Arkansas Clinic, Jonesboro,  Arkansas,  72401,  United States
California
      Ronald Yanagiharaa, M.D., Gilroy,  California,  95020,  United States
      Cancer Institute Medical Group, Los Angeles,  California,  90025,  United States
      Providence St. Joseph Medical Center, Burbank,  California,  91505,  United States
      Pacific Shores Medical Group, Long Beach,  California,  90813,  United States
      UCLA School of Medicine, Los Angeles,  California,  90095,  United States
      Compassionate Cancer Care Medical Group, Inc, Fountain Valley,  California,  92708,  United States
      The Lucy Curci Cancer Center, Rancho Mirage,  California,  92270,  United States
      Santa Clara Valley Medical Center, San Jose,  California,  95128,  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
      Comprehensive Blood and Cancer Center, Bakersfield,  California,  93309,  United States
      California Oncology of the Central Valley, Fresno,  California,  93710,  United States
      Virginia K. Crosson Cancer Center, Fullerton,  California,  92835,  United States
      Wilshire Oncology Medical Group, Pomona,  California,  91767,  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
      Sierra View District Hospital, Porterville,  California,  93257,  United States
      Cancer Care Associates Medical Group, Inc., Redondo Beach,  California,  90277,  United States
      Santa Barbara Hematology Oncology Medical Group, Inc., Santa Barbara,  California,  93105,  United States
      Sansum Santa Barbara Foundation Medical Clinic, Santa Barbara,  California,  93105,  United States
      San Diego Cancer Center Medical Group, Vista,  California,  92083,  United States
      Glendale Adventist Medical Center Cancer Center, Glendale,  California,  91206,  United States
      Pacific Hematology Oncology Associates, San Francisco,  California,  94904,  United States
Colorado
      Jennifer Caskey, M.D., Wheat Ridge,  Colorado,  08833,  United States
      Colorado Cancer Research Program, Denver,  Colorado,  80224,  United States
Connecticut
      Davis, Posteraro and Wasser, MD's, LLP, Manchester,  Connecticut,  06040,  United States
      Connecticut Oncology Group, Middletown,  Connecticut,  06457,  United States
Delaware
      Medical Oncology Hematology Consultants, Newark,  Delaware,  19808,  United States
District of Columbia
      Washington Oncology-Hematology Center, Washington,  District of Columbia,  20016,  United States
      George Washington University Medical Center, Washington,  District of Columbia,  20037,  United States
Florida
      Innovative Medical Research of South Florida, Miami Shores,  Florida,  33138,  United States
      Lakeland Regional Cancer Center, Lakeland,  Florida,  33803,  United States
      Florida Cancer Specialists, Ft. Myers,  Florida,  33901,  United States
      Hematology Oncology Associates of Treasure, Port St. Lucie,  Florida,  34952,  United States
      Florida Oncology Associates, Jacksonville,  Florida,  32204,  United States
      Oncology Hematology Group of South Florida, Miami,  Florida,  33176,  United States
      Florida Medical Clinic, PA, Zephyrhills,  Florida,  33542,  United States
      Boca Raton Comprehensive Cancer Center, Boca Raton,  Florida,  33486,  United States
      Memorial Healthcare System, Hollywood,  Florida,  33021,  United States
Georgia
      Peachtree Hematology and Oncology, Atlanta,  Georgia,  40202,  United States
      Coastal Hematology & Oncology, Savannah,  Georgia,  31406,  United States
Idaho
      North Idaho Cancer Center, Couer D'Alene,  Idaho,  83814,  United States
Illinois
      Northshore Cancer Research Association, Skokie,  Illinois,  60076,  United States
      Midwest Cancer Research Group, Skokie,  Illinois,  60077,  United States
      Shelby D. Rifkin, M.D., Arlington Heights,  Illinois,  60004,  United States
      Oncology Hematology Associates of Central Illinois, PC, Peoria,  Illinois,  61602,  United States
      Monroe Medical Associates, Harvey,  Illinois,  60426,  United States
Indiana
      Associated Physicians & Surgeons Clinic, L.L.C., Terre Haute,  Indiana,  47804,  United States
      Hematology-Oncology of Indiana, PC, Indianapolis,  Indiana,  46260,  United States
Kentucky
      Norton Healthcare Pavilion, Louisville,  Kentucky,  40202,  United States
      Vijay Raghavan, M.D., Louisville,  Kentucky,  40215,  United States
      Markey Clinical Oncology Research Program, Lexington,  Kentucky,  40536-0098,  United States
Louisiana
      LSU Medical Center, New Orleans,  Louisiana,  70112,  United States
      Louisiana Oncology Associates, Lafayette,  Louisiana,  70506,  United States
      LSU Health Sciences Center, Shreveport,  Louisiana,  71130-3932,  United States
      Tulane University Health Sciences Center, New Orleans,  Louisiana,  70112,  United States
Maine
      Maine Center for Cancer Medicine & Blood Disorders, Scarborough,  Maine,  04074,  United States
Maryland
      St. Agnes Healthcare, Inc., Baltimore,  Maryland,  21229-5299,  United States
      Kaiser Permanente, Rockville,  Maryland,  20850,  United States
Michigan
      Spectrum Health -- Cook Research Dept., Grand Rapids,  Michigan,  49503,  United States
      Providence Cancer Center, Southfield,  Michigan,  48075,  United States
      Hematology and Oncology Assoc. of Southern Mississippi, Jackson,  Michigan,  48201,  United States
      Josephine Ford Cancer Center, Detroit,  Michigan,  48202,  United States
      Genesys Hurley Cancer Institute, Flint,  Michigan,  48503,  United States
      Oncology Care Associates, PLLC, St. Joseph,  Michigan,  49085,  United States
      St. Joseph Mercy Hospital, Ann Arbor,  Michigan,  48106-0995,  United States
Minnesota
      SMDC Health System, Duluth,  Minnesota,  55805,  United States
      University of Minnesota Cancer Center, Minneapolis,  Minnesota,  55455,  United States
      Metro Minnesota CCOP, St. Louis Park,  Minnesota,  55426,  United States
      Minnesota CGOP, Minneapolis,  Minnesota,  55407,  United States
Missouri
      Arch Medical Services Incorporated, St. Louis,  Missouri,  63141,  United States
      Kansas City Oncology and Hematology Group, Kansas City,  Missouri,  64131,  United States
      Saint Louis University, St. Louis,  Missouri,  63110,  United States
      Missouri Cancer Care, PC, St. Charles,  Missouri,  63301,  United States
      Washington University School of Medicine, St. Louis,  Missouri,  63110,  United States
      Missouri Baptist Cancer Center, St. Louis,  Missouri,  63131,  United States
      Heartland Hematology/Oncology Associates, Inc., Kansas City,  Missouri,  64118,  United States
Montana
      North Central Montana Professional Building, Great Falls,  Montana,  59405,  United States
      Montana Cancer Specialists, Missoula,  Montana,  59807-7877,  United States
Nebraska
      The Methodist Cancer Center, Omaha,  Nebraska,  68114,  United States
Nevada
      Nevada Cancer Center, Las Vegas,  Nevada,  89109,  United States
      Comprehensive Cancer Centers of Nevada, Las Vegas,  Nevada,  89109,  United States
New Jersey
      Hematology-Oncology Associates of New Jersey, Morristown,  New Jersey,  07960,  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
      Cooper Cancer Institute, Voorhees,  New Jersey,  08043,  United States
      Southern Oncology and Hematology Associates, Vineland,  New Jersey,  08360,  United States
New Mexico
      New Mexico Cancer Care, Santa Fe,  New Mexico,  87505,  United States
New York
      Roswell Park Cancer Institute, Buffalo,  New York,  14263,  United States
      Cancer Research of Long Island, Great Neck,  New York,  11023,  United States
      New York Oncology Hematology, Latham,  New York,  12110,  United States
      Broome Oncology, Johnson City,  New York,  13790,  United States
      Pluta Cancer Center, Rochester,  New York,  14623,  United States
      North Shore University Hospital, Manhasset,  New York,  11030,  United States
      Cancer Center at Nyack Hospital, Nyack,  New York,  10960,  United States
      CR Wood Cancer Center, Glen Falls,  New York,  12801,  United States
North Carolina
      Carolina Medical Center, Charlotte,  North Carolina,  28203,  United States
North Dakota
      Mid-Dakota Clinic PC, Bismarck,  North Dakota,  58501,  United States
Ohio
      Nashat Gabrail, M.D., Canton,  Ohio,  44718,  United States
      Hematology Oncology Consultants, Inc., Columbus,  Ohio,  43235,  United States
      Meridia Cancer Institute, Mayfield Heights,  Ohio,  44124,  United States
      Mid Ohio Oncology/Hematology, Inc., Columbus,  Ohio,  43213,  United States
Oklahoma
      Cancer Care Associates, Oklahoma City,  Oklahoma,  73112,  United States
      Cancer Care Associates, Tulsa,  Oklahoma,  74136-1929,  United States
Oregon
      Kaiser Permanente Oncology Hematology, Portland,  Oregon,  97227,  United States
Pennsylvania
      Allegheny Cancer Center, Pittsburgh,  Pennsylvania,  15212-4772,  United States
      University of Pennsylvania Abramson Cancer Center, Philadelphia,  Pennsylvania,  19104,  United States
      Hershey Medical Center, Hershey,  Pennsylvania,  17033,  United States
      Monogahela Valley Hospital, Monogahela,  Pennsylvania,  15063,  United States
South Carolina
      Charleston Cancer Center, Charleston,  South Carolina,  29406,  United States
      Cancer Center of the Carolinas, Greenville,  South Carolina,  29615,  United States
      South Carolina Oncology Associates, Columbia,  South Carolina,  29201,  United States
      Charleston Hematology Oncology, Charleston,  South Carolina,  29403,  United States
      Spartanburg Regional Medical Center, Spartanburg,  South Carolina,  29303,  United States
Tennessee
      University of Tennessee Cancer Institute, Memphis,  Tennessee,  38104,  United States
      Sarah Cannon Cancer Center, Nashville,  Tennessee,  37203,  United States
      The Jones Clinic, Germantown,  Tennessee,  38138,  United States
      Baptist Regional Cancer Center, Knoxville,  Tennessee,  37920,  United States
Texas
      M.D. Anderson Cancer Center, Houston,  Texas,  77030,  United States
      Southwest Regional Cancer Center, Austin,  Texas,  78705,  United States
      H. Alejandro Preti, MD, PA, Houston,  Texas,  77030,  United States
      Center for Oncology Research & Treatment, PA, Dallas,  Texas,  75230,  United States
      Scott & White Hospital, Temple,  Texas,  76508,  United States
      Corpus Christi Cancer Center, Corpus Christi,  Texas,  78412,  United States
      Dr. Lee C. Drinkard, Irving,  Texas,  75038,  United States
      Oncology Consultants, Houston,  Texas,  77024,  United States
Utah
      Utah Cancer Specialists, Salt Lake City,  Utah,  84124,  United States
      North Utah Associates, Ogden,  Utah,  84403-3105,  United States
Vermont
      Southwestern Vermont Health Care, Bennington,  Vermont,  05201,  United States
Virginia
      Northern Virginia Oncology Group, Fairfax,  Virginia,  22031,  United States
      Virginia Cancer Institute, Richmond,  Virginia,  23230,  United States
      Cancer Treatment Centers of America, Portsmouth,  Virginia,  23704,  United States
      Danville Hematology and Oncology, Inc., Danville,  Virginia,  24541,  United States
      Virginia Oncology Associates, Norfolk,  Virginia,  23502,  United States
Washington
      Cascade Cancer Center, Kirkland,  Washington,  98034,  United States
      Western Washington Medical Group, Everett,  Washington,  982901,  United States
      Western Washington Medical Group, Everett,  Washington,  98201,  United States
Wisconsin
      UW Health -- University of Wisconsin Comp, Madison,  Wisconsin,  53792,  United States
      Waukesha Memorial Hospital, Waukesha,  Wisconsin,  53188,  United States
Canada, Ontario
      Toronto East General Hospital, Toronto,  Ontario,  M4C 3E7,  Canada
      Hamilton Regional Cancer Center, Hamilton,  Ontario,  L8V 5C2,  Canada
      Princess Margaret Hospital, Toronto,  Ontario,  M5G 2M9,  Canada
Canada, Quebec
      Hopital Laval, Sainte-Foy,  Quebec,  G1V 4G5,  Canada
Taiwan, Province of China
      MacKay Memorial Hospital, Taipei,  Taiwan, Province of China
      Chang-Gung Memorial Hospital, Tao-Yuan,  Taiwan, Province of China
      Taipei Veterans General Hospital, Taipei,  Taiwan, Province of China
      Tri-Services General Hospital, Taipei,  Taiwan, Province of China
      Koo Foundation Sun Yat-Sen Cancer Center, Taipei,  Taiwan, Province of China
      National Taiwan University Hospital, Taipei,  Taiwan, Province of China
      National Cheng Kung University Hospital, Tainan,  70441,  Taiwan, Province of China

Study ID Numbers:  CPTK787 0135/306241; CONFIRM 1
Record last reviewed:  July 2004
Last Updated:  October 13, 2004
Record first received:  March 13, 2003
ClinicalTrials.gov Identifier:  NCT00056459
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08