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| Sponsor: | Novartis Pharmaceuticals |
|---|---|
| Collaborator: |
Bayer |
| Information provided by: | Novartis |
| ClinicalTrials.gov Identifier: | NCT00056446 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Neoplasms Colonic Neoplasms Rectal Neoplasms |
Drug: Vatalanib |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study |
| 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 |
| Enrollment: | 855 |
| Study Start Date: | January 2003 |
| Estimated Study Completion Date: | October 2004 |
| Primary Completion Date: | January 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Oxaliplatin/5-FU/LV and PTK787/ZK 222584
|
Drug: Vatalanib |
|
2: Placebo Comparator
Oxaliplatin/5-FU/LV and placebo
|
Drug: Vatalanib |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion criteria
Exclusion criteria
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| Comprehensive Cancer Institute | |
| Huntsville, Alabama, United States, 35801 | |
| United States, Alaska | |
| Alaska Oncology and Hematology | |
| Anchorage, Alaska, United States, 99508 | |
| United States, Arizona | |
| Arizona Clinical Research Center | |
| Tucson, Arizona, United States, 85712 | |
| United States, Arkansas | |
| Arkansas Cancer Research Center | |
| Little Rock, Arkansas, United States, 72205 | |
| Northeast Arkansas Clinic | |
| Jonesboro, Arkansas, United States, 72401 | |
| Little Rock Hematology & Oncology | |
| Little Rock, Arkansas, United States, 72205 | |
| Highlands Oncology Group | |
| Springdale, Arkansas, United States, 72764 | |
| United States, California | |
| Comprehensive Blood and Cancer Center | |
| Bakersfield, California, United States, 93309 | |
| UCLA School of Medicine | |
| Los Angeles, California, United States, 90095 | |
| Pacific Shores Medical Group | |
| Long Beach, California, United States, 90813 | |
| Compassionate Cancer Care Medical Group, Inc. | |
| Fountain Valley, California, United States, 92708 | |
| Santa Clara Valley Medical Center | |
| San Jose, California, United States, 95128 | |
| Synergy Hematology-Oncology Medical Associates | |
| Los Angeles, California, United States, 90036 | |
| USC Norris Cancer Center | |
| Los Angeles, California, United States, 90033 | |
| Medical Oncology Care Associates | |
| Orange, California, United States, 92868 | |
| California Oncology of the Central Valley | |
| Fresno, California, United States, 93710 | |
| Virginia K. Crosson Cancer Center | |
| Fullerton, California, United States, 92835 | |
| Wilshire Oncology Medical Group | |
| La Verne, California, United States, 91767 | |
| Eddie Hong-Lung Hu, M.D. | |
| Monterey Park, California, United States, 91754 | |
| Cancer Care Associates Medical Group, Inc. | |
| Redondo Beach, California, United States, 90277 | |
| Ventura County Hematology-Oncology Specialists | |
| Oxnard, California, United States, 93030 | |
| Sierra View District Hospital | |
| Porterville, California, United States, 93257 | |
| North Valley Hematology/Oncology Medical Group | |
| Northridge, California, United States, 91328 | |
| Santa Barbara Hematology Oncology Medical Group, Inc. | |
| Santa Barbara, California, United States, 93105 | |
| Sansum Santa Barbara Foundation Medical Clinic | |
| Santa Barbara, California, United States, 93105 | |
| San Diego Cancer Center Medical Group | |
| Vista, California, United States, 92083 | |
| Providence St. Joseph Medical Center | |
| Burbank, California, United States, 91505 | |
| Glendale Adventist Medical Center | |
| Glendale, California, United States, 91206 | |
| Scripps Green Hospital | |
| La Jolla, California, United States, 92037 | |
| Los Angeles, California, United States, 90095 | |
| United States, Colorado | |
| Rocky Mountain Cancer Center | |
| Denver, Colorado, United States, 80220 | |
| Mile High Oncology | |
| Denver, Colorado, United States, 80210 | |
| United States, Connecticut | |
| Manchester Hematology/Oncology Assoc. | |
| Manchester, Connecticut, United States, 06040 | |
| United States, District of Columbia | |
| Washington Oncology/Hematology Center | |
| Washington, District of Columbia, United States, 20037 | |
| United States, Florida | |
| Hematology Oncology Associates of Treasure Coast | |
| Port St. Lucie, Florida, United States, 34952 | |
| Hematology Oncology Associates | |
| Lake Worth, Florida, United States, 33461-4710 | |
| The Center for Hematology and Oncology | |
| Boca Raton, Florida, United States, 33486 | |
| Florida Medical Clinic | |
| Zephyrhills, Florida, United States, 33542 | |
| Oncology/Hematology Group of South Florida | |
| Miami, Florida, United States, 33176 | |
| Florida Cancer Specialists | |
| Ft. Myers, Florida, United States, 33901 | |
| University of Miami School of Medicine | |
| Miami, Florida, United States, 33136 | |
| United States, Georgia | |
| Atlanta Cancer Care | |
| Marietta, Georgia, United States, 30060 | |
| Lewis Hall Singletary Oncology Center | |
| Thomasville, Georgia, United States, 31792 | |
| Coastal Hematology & Oncology | |
| Savannah, Georgia, United States, 31406 | |
| Office of Research | |
| Savannah, Georgia, United States, 31405 | |
| United States, Idaho | |
| North Idaho Cancer Center | |
| Coeur d"Alene, Idaho, United States, 83814 | |
| United States, Illinois | |
| Midwest Cancer Research Group | |
| Skokie, Illinois, United States, 60077 | |
| University of Chicago medical Center, Hematology/Oncology | |
| Chicago, Illinois, United States, 60637 | |
| Northshore Cancer Research Association | |
| Skokie, Illinois, United States, 60076 | |
| Oncology Hematology Associates of Central Illinois, PC | |
| Peoria, Illinois, United States, 61602 | |
| United States, Indiana | |
| Munster Community Hospital | |
| Munster, Indiana, United States, 46321 | |
| Fort Wayne Medical Oncology & Hematology, Inc. | |
| Fort Wayne, Indiana, United States, 46815 | |
| United States, Kansas | |
| Cotton O'Neil Oncology Clinic | |
| Topeka, Kansas, United States, 66606 | |
| United States, Kentucky | |
| Vijay Raghaven, M.D. | |
| Louisville, Kentucky, United States, 40215 | |
| Owensboro Medical Health System | |
| Owensboro, Kentucky, United States, 42303 | |
| United States, Louisiana | |
| LSU Health Sciences Center | |
| Shreveport, Louisiana, United States, 71130-3932 | |
| LSU Medical Center | |
| New Orleans, Louisiana, United States, 70112 | |
| Cabrini Center for Cancer Care | |
| Alexandria, Louisiana, United States, 71301 | |
| Tulane University Health Sciences Center | |
| New Orleans, Louisiana, United States, 70112 | |
| United States, Maine | |
| Maine Center for Cancer Medicine & Blood Disorders | |
| Scarborough, Maine, United States, 04074 | |
| United States, Maryland | |
| Franklin Square Hospital Center | |
| Baltimore, Maryland, United States, 21237 | |
| St. Agnes Healthcare | |
| Baltimore, Maryland, United States, 21229-5299 | |
| Kaiser Permanente | |
| Rockville, Maryland, United States, 20850 | |
| United States, Massachusetts | |
| Fallon Clinic at Worcester Medical Center | |
| Worcester, Massachusetts, United States, 01605 | |
| United States, Michigan | |
| Spectrum Health -- Cook Research Dept. | |
| Grand Rapids, Michigan, United States, 49503 | |
| University of Michigan | |
| Ann Arbor, Michigan, United States, 48109-0934 | |
| Providence Cancer Center | |
| Southfield, Michigan, United States, 48075 | |
| Oncology Care Associates, PLLC | |
| St. Joseph, Michigan, United States, 49085 | |
| United States, Minnesota | |
| Minnesota CGOP | |
| Minneapolis, Minnesota, United States, 55407 | |
| United States, Missouri | |
| Arch Medical Services Incorporated | |
| St. Louis, Missouri, United States, 63141 | |
| Saint Louis University | |
| St. Louis, Missouri, United States, 63110 | |
| Missouri Cancer Care, PC | |
| St. Charles, Missouri, United States, 63301 | |
| Missouri Baptist Cancer Center | |
| St. Louis, Missouri, United States, 63131 | |
| Heartland Hematology | |
| Kansas City, Missouri, United States, 64118 | |
| Washington University School of Medicine | |
| St. Louis, Missouri, United States, 63110 | |
| United States, Montana | |
| North Central Montana Professional Building | |
| Great Falls, Montana, United States, 59405 | |
| United States, Nevada | |
| Nevada Cancer Center | |
| Las Vegas, Nevada, United States, 89109 | |
| Comprehensive Cancer Centers of Nevada | |
| Las Vegas, Nevada, United States, 89109 | |
| United States, New Hampshire | |
| NH Oncology-Hematology, PA | |
| Hooksett, New Hampshire, United States, 03106 | |
| United States, New Jersey | |
| Hematology Oncology Associates of Northern New Jersey | |
| Morristown, New Jersey, United States, 07960 | |
| Center for Cancer and Hematologic Disease | |
| Cherry Hill, New Jersey, United States, 08003 | |
| Cooper Cancer Center | |
| Voorhees, New Jersey, United States, 08043 | |
| St. Barnabas Cancer Center | |
| Livingston, New Jersey, United States, 07039 | |
| United States, New Mexico | |
| New Mexico Oncology/Hematology | |
| Albuquerque, New Mexico, United States, 87109 | |
| Hematology/Oncology Associates | |
| Albuquerque, New Mexico, United States, 87102 | |
| United States, New York | |
| Roswell Park Cancer Institute | |
| Buffalo, New York, United States, 14263 | |
| Queens Medical Associates, PC | |
| Fresh Meadows, New York, United States, 11365 | |
| Charles R. Wood Cancer Center | |
| Glens Falls, New York, United States, 12801 | |
| Pluta Cancer Center | |
| Rochester, New York, United States, 14623 | |
| Hematology-Oncology Associates of Rockland | |
| Nyack, New York, United States, 10956 | |
| James P. Wilmot Cancer Center | |
| Rochester, New York, United States, 14642 | |
| Hematology/Oncology Associates of Central NY | |
| East Syracuse, New York, United States, 13057 | |
| North Shore University Hospital | |
| Manhasset, New York, United States, 11030 | |
| St. Vincent's Catholic Medical Centers of New York | |
| New York, New York, United States, 10011 | |
| United States, North Carolina | |
| Carolinas Hematology/Oncology Associates | |
| Charlotte, North Carolina, United States, 28203 | |
| Lineberger Comprehensive Cancer Center | |
| Chapel Hill, North Carolina, United States, 27599-7305 | |
| United States, Ohio | |
| Nashat Gabrail, M.D. | |
| Canton, Ohio, United States, 44718 | |
| The Cleveland Clinic Foundation | |
| Cleveland, Ohio, United States, 44195 | |
| Case Western Reserve University | |
| Cleveland, Ohio, United States, 44106-5056 | |
| Columbus CCOP | |
| Columbus, Ohio, United States, 43206 | |
| United States, Oklahoma | |
| Oklahoma Oncology, Inc. | |
| Tulsa, Oklahoma, United States, 74104 | |
| The University of Oklahoma Health Sciences Center | |
| Oklahoma City, Oklahoma, United States, 73104 | |
| United States, Pennsylvania | |
| Thomas Jefferson University Hospital | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| Consultants in Medical Oncology & Hematology | |
| Drexel Hill, Pennsylvania, United States, 19026 | |
| Allegheny General Hospital | |
| Pittsburgh, Pennsylvania, United States, 15212-4772 | |
| Hematology & Oncology Associates of NE PA | |
| Dunmore, Pennsylvania, United States, 18512 | |
| Monongahela Valley Hospital | |
| Monongahela, Pennsylvania, United States, 15063 | |
| Penn State Hershey Medical Center | |
| Hershey, Pennsylvania, United States, 17033-0850 | |
| UPMC Cancer Pavillion | |
| Pittsburgh, Pennsylvania, United States, 15232 | |
| United States, South Carolina | |
| South Carolina Oncology Associates | |
| Columbia, South Carolina, United States, 29201 | |
| Cancer Center of the Carolinas | |
| Greenville, South Carolina, United States, 29615 | |
| Charleston Cancer Center | |
| Charleston, South Carolina, United States, 29406 | |
| Spartanburg Regional Medical Center | |
| Spartanburg, South Carolina, United States, 29303 | |
| WJB Dom VAMC | |
| Columbia, South Carolina, United States, 29209 | |
| United States, Tennessee | |
| Baptist Regional Cancer Center | |
| Knoxville, Tennessee, United States, 37920 | |
| University of Tennessee Cancer Institute | |
| Memphis, Tennessee, United States, 38104 | |
| The Jones Clinic | |
| Germantown, Tennessee, United States, 38138 | |
| Sarah Cannon Cancer Center | |
| Nashville, Tennessee, United States, 37203 | |
| Vanderbilt University School of Medicine | |
| Nashville, Tennessee, United States, 37232-6307 | |
| Clarksville Regional Hematology/Oncology | |
| Clarksville, Tennessee, United States, 37043 | |
| Erlanger Health System | |
| Chattanooga, Tennessee, United States, 37403 | |
| Meharry Medical College | |
| Nashville, Tennessee, United States, 37208 | |
| Vanderbilt-Ingram Cancer Center | |
| Nashville, Tennessee, United States, 37212 | |
| United States, Texas | |
| H. Alejandro Preti, M.D., PA | |
| Houston, Texas, United States, 77030 | |
| Harrington Cancer Center | |
| Amarillo, Texas, United States, 79106 | |
| M.D. Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| South Texas Oncology & Hematology | |
| San Antonio, Texas, United States, 78207 | |
| Center for Oncology Research & Treatment | |
| Dallas, Texas, United States, 75230 | |
| Oncology Consultants | |
| Houston, Texas, United States, 77024 | |
| Scott & White Hospital | |
| Temple, Texas, United States, 76508 | |
| Clinical Hematology & Oncology | |
| Dallas, Texas, United States, 75235 | |
| United States, Utah | |
| Northern Utah Cancer Associates | |
| Ogden, Utah, United States, 84403 | |
| United States, Vermont | |
| Southwestern Vermont Health Care | |
| Bennington, Vermont, United States, 05201 | |
| United States, Virginia | |
| Cancer Treatment Centers of America in Hampton Roads | |
| Portsmouth, Virginia, United States, 23704 | |
| Virginia Oncology Associates | |
| Norfolk, Virginia, United States, 23502 | |
| United States, Washington | |
| Swedish Cancer Institute | |
| Seattle, Washington, United States, 98104 | |
| Cascade Cancer Center | |
| Kirkland, Washington, United States, 98034 | |
| Western Washington Clinic | |
| Everett, Washington, United States, 98201 | |
| Virginia Mason Medical Center | |
| Seattle, Washington, United States, 98101 | |
| Rainier Oncology | |
| Puyallup, Washington, United States, 98372 | |
| United States, West Virginia | |
| West Virginia University Health Sciences Center | |
| Morgantown, West Virginia, United States, 26506 | |
| United States, Wisconsin | |
| Kettle Morain Oncology | |
| West Bend, Wisconsin, United States, 53095 | |
| Waukesha Memorial Hospital | |
| Waukesha, Wisconsin, United States, 53188 | |
| Australia | |
| Woodville South, Australia, SA | |
| Frankston, Australia, VIC | |
| Austria | |
| St. Veit An Der Glan, Austria, 9300 | |
| Belgium | |
| Leuven, Belgium | |
| Bruxelles, Belgium, 1200 | |
| Wilrijk, Belgium, 2610 | |
| Brasschaat, Belgium, 2930 | |
| Antwerpen, Belgium, 2020 | |
| Liège, Belgium, 4000 | |
| Brazil | |
| Salvador, Bahia, Brazil, CEP 40170-070 | |
| Salvador - Ba, Brazil, 41825-010 | |
| Sao Paulo, Brazil, 01308-050 | |
| Sao Paulo, Brazil, 01236-000 | |
| Porto Alegre Rs, Brazil, CEP 90 610-000 | |
| Sao Paulo, Brazil, 01406-100 | |
| Canada, Alberta | |
| Calgary, Alberta, Canada, T2N4N2 | |
| Canada, British Columbia | |
| Penticton, British Columbia, Canada, V2A3G6 | |
| Canada, Manitoba | |
| Winnepeg, Manitoba, Canada, R2H 2A6 | |
| Canada, Nova Scotia | |
| Sydney, Nova Scotia, Canada, B1P 1P3 | |
| Canada, Ontario | |
| Toronto, Ontario, Canada, M4C 3E7 | |
| Sudbury, Ontario, Canada, P3E 5J1 | |
| Hamilton, Ontario, Canada, L8V 5C2 | |
| Barrie, Ontario, Canada, L4M6M2 | |
| Thunder Bay, Ontario, Canada, P7A 7T1 | |
| Sainte-Foy, Ontario, Canada, G1V 4G5 | |
| Toronto, Ontario, Canada, M5G1X5 | |
| Toronto, Ontario, Canada, M4N3M5 | |
| Ottawa, Ontario, Canada, K1H 1C4 | |
| Windsor, Ontario, Canada, N8W 2X3 | |
| Toronto, Ontario, Canada | |
| St. Catharines, Ontario, Canada, L2R5K3 | |
| Brampton, Ontario, Canada, L6W 2Z8 | |
| Canada, Quebec | |
| Montreal, Quebec, Canada, H2L 4M1 | |
| Greenfield Park, Quebec, Canada, J4V2H1 | |
| Montreal, Quebec, Canada, H2W 1S6 | |
| Canada, Saskatchewan | |
| Saskatoon, Saskatchewan, Canada, S7N4H4 | |
| France | |
| Boulogne Cedex, France, 92104 | |
| Saint Herblain, France, 44805 | |
| Nice Cedex 2, France, 6189 | |
| Montpellier Cedex 5, France, 34298 | |
| Marseille Cedex 05, France, 13385 | |
| Toulouse Cedex, France, 31052 | |
| Rennes Cedex, France, 35042 | |
| Strasbourg, France, 67000 | |
| Lille Cedex, France, 59020 | |
| Avignon, France, 84000 | |
| Germany | |
| Essen, Germany, 45122 | |
| Dresden, Germany, 1307 | |
| Hannover, Germany, 30625 | |
| Frankfurt, Germany, 60488 | |
| Wiesbaden, Germany, 65199 | |
| Augsburg, Germany, 86150 | |
| Ulm, Germany, 89081 | |
| Köln, Germany, 50677 | |
| München, Germany, 81675 | |
| Trier, Germany, 54290 | |
| Essen, Germany, 45136 | |
| Magdeburg, Germany, 39002 | |
| Berlin, Germany, 14195 | |
| Braunschweig, Germany, 38100 | |
| Dessau, Germany, 6822 | |
| Berlin, Germany, 13585 | |
| Neumünster, Germany, 24534 | |
| Hamburg, Germany, 22087 | |
| Bielefeld, Germany, 33604 | |
| Hong Kong | |
| ChaiWan, Hong Kong | |
| Italy | |
| Milano, Italy, 20141 | |
| Ancona, Italy, 60020 | |
| Milano, Italy, 20100 | |
| Roma, Italy, 149 | |
| Livorno, Italy, 57100 | |
| Reggio Emilia, Italy, 42100 | |
| Brescia, Italy, 25124 | |
| Roma, Italy, 135 | |
| Bergamo, Italy, 24128 | |
| Rozzano, Italy, 20089 | |
| Genova, Italy, 16132 | |
| Cremona, Italy, 26100 | |
| New Zealand | |
| Auckland, New Zealand | |
| Wellington, New Zealand | |
| Christchurch, New Zealand | |
| Portugal | |
| Lisboa, Portugal, 1649-035 | |
| Coimbra, Portugal, 3000-076 | |
| Slovakia | |
| Bratislava, Slovakia, 81250 | |
| Spain | |
| Elche, Spain, 3202 | |
| Madrid, Spain, 28040 | |
| Malaga, Spain, 29010 | |
| Cordoba, Spain, 14004 | |
| Hospitalet de Llobregat, Spain, 8907 | |
| Madrid, Spain, 28033 | |
| Zaragoza, Spain, 5009 | |
| Madrid, Spain, 28007 | |
| Sweden | |
| Stockholm, Sweden, SE-118 83 | |
| Goteborg, Sweden, SE-416 85 | |
| Switzerland | |
| Bern, Switzerland, 3010 | |
| Thun, Switzerland, 3600 | |
| Taiwan | |
| Changhua, Taiwan | |
| Taichung, Taiwan | |
| Keelung, Taiwan | |
| Tao-Yuan, Taiwan | |
| Tainan, Taiwan | |
| Taipei, Taiwan | |
| Kaohsiung, Taiwan | |
| United Kingdom | |
| Cardiff, United Kingdom, CF147TB | |
| Manchester, United Kingdom, M20 4BX | |
| Birmingham, United Kingdom, B15 2TH | |
| Belfast, United Kingdom, BT9 7AB | |
| London, United Kingdom, W1T 3AA | |
| Study Chair: | Novartis/Schering AG, Germany | Novartis / Schering AG Germany |
More Information
| Responsible Party: | Novartis ( External Affairs ) |
| Study ID Numbers: | CPTK787 0133/304946 |
| Study First Received: | March 13, 2003 |
| Last Updated: | November 18, 2009 |
| ClinicalTrials.gov Identifier: | NCT00056446 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Colorectal Cancer Oxaliplatin VEGF inhibitor Vatalanib PTK787 |
Colon Cancer Colorectal Carcinoma Rectal Cancer Colorectal Tumor |
|
Molecular Mechanisms of Pharmacological Action Gastrointestinal Diseases Rectal Neoplasms Antineoplastic Agents Colonic Diseases Physiological Effects of Drugs Leucovorin Rectal Diseases Protein Kinase Inhibitors Vatalanib Oxaliplatin Neoplasms by Site Vitamins Therapeutic Uses |
Micronutrients Digestive System Neoplasms Vitamin B Complex Growth Substances Enzyme Inhibitors Intestinal Diseases Intestinal Neoplasms Pharmacologic Actions Neoplasms Digestive System Diseases Gastrointestinal Neoplasms Colonic Neoplasms Colorectal Neoplasms |
