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| Sponsor: | Novartis |
|---|---|
| Collaborator: |
Bayer |
| Information provided by: | Novartis |
| ClinicalTrials.gov Identifier: | NCT00056459 |
Purpose
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
| 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 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 |
| Enrollment: | 1168 |
| Study Start Date: | February 2003 |
| Estimated Study Completion Date: | May 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:
Other protocol-defined inclusion / exclusion criteria may apply
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| Alabama Hematology/Oncology | |
| Birmingham, Alabama, United States, 35243 | |
| United States, Arizona | |
| Arizona Cancer Center | |
| Tucson, Arizona, United States, 85724 | |
| Palo Verde Hematology & Oncology | |
| Glendale, Arizona, United States, 85304 | |
| United States, Arkansas | |
| Highlands Oncology Group | |
| Springdale, Arkansas, United States, 72764 | |
| Northeast Arkansas Clinic | |
| Jonesboro, Arkansas, United States, 72401 | |
| United States, California | |
| Ronald Yanagiharaa, M.D. | |
| Gilroy, California, United States, 95020 | |
| Cancer Institute Medical Group | |
| Los Angeles, California, United States, 90025 | |
| Providence St. Joseph Medical Center | |
| Burbank, California, United States, 91505 | |
| Pacific Shores Medical Group | |
| Long Beach, California, United States, 90813 | |
| UCLA School of Medicine | |
| Los Angeles, California, United States, 90095 | |
| Compassionate Cancer Care Medical Group, Inc | |
| Fountain Valley, California, United States, 92708 | |
| The Lucy Curci Cancer Center | |
| Rancho Mirage, California, United States, 92270 | |
| Santa Clara Valley Medical Center | |
| San Jose, California, United States, 95128 | |
| San Diego Cancer Center Medical Group | |
| Vista, California, United States, 92083 | |
| Synergy Hematology-Oncology Medical Associates | |
| Los Angeles, California, United States, 90057 | |
| Comprehensive Blood and Cancer Center | |
| Bakersfield, California, United States, 93309 | |
| 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 | |
| Pomona, California, United States, 91767 | |
| Eddie Hong-Lung Hu, M.D. | |
| Monterey Park, California, United States, 91754 | |
| North Valley Hematology/Oncology Medical Group | |
| Northridge, California, United States, 91328 | |
| Ventura County Hematology-Oncology Specialists | |
| Oxnard, California, United States, 93030 | |
| Sierra View District Hospital | |
| Porterville, California, United States, 93257 | |
| Cancer Care Associates Medical Group, Inc. | |
| Redondo Beach, California, United States, 90277 | |
| 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 | |
| USC/Norris Comprehensive Cancer Care Center | |
| Los Angeles, California, United States, 90033 | |
| Glendale Adventist Medical Center Cancer Center | |
| Glendale, California, United States, 91206 | |
| Pacific Hematology Oncology Associates | |
| San Francisco, California, United States, 94904 | |
| United States, Colorado | |
| Jennifer Caskey, M.D. | |
| Wheat Ridge, Colorado, United States, 08833 | |
| Colorado Cancer Research Program | |
| Denver, Colorado, United States, 80224 | |
| United States, Connecticut | |
| Davis, Posteraro and Wasser, MD's, LLP | |
| Manchester, Connecticut, United States, 06040 | |
| Connecticut Oncology Group | |
| Middletown, Connecticut, United States, 06457 | |
| United States, Delaware | |
| Medical Oncology Hematology Consultants | |
| Newark, Delaware, United States, 19808 | |
| United States, District of Columbia | |
| Washington Oncology-Hematology Center | |
| Washington, District of Columbia, United States, 20016 | |
| George Washington University Medical Center | |
| Washington, District of Columbia, United States, 20037 | |
| United States, Florida | |
| Innovative Medical Research of South Florida | |
| Miami Shores, Florida, United States, 33138 | |
| Lakeland Regional Cancer Center | |
| Lakeland, Florida, United States, 33803 | |
| Florida Oncology Associates | |
| Jacksonville, Florida, United States, 32204 | |
| Hematology Oncology Associates of Treasure | |
| Port St. Lucie, Florida, United States, 34952 | |
| Florida Cancer Specialists | |
| Ft. Myers, Florida, United States, 33901 | |
| Oncology Hematology Group of South Florida | |
| Miami, Florida, United States, 33176 | |
| Florida Medical Clinic, PA | |
| Zephyrhills, Florida, United States, 33542 | |
| Boca Raton Comprehensive Cancer Center | |
| Boca Raton, Florida, United States, 33486 | |
| Memorial Healthcare System | |
| Hollywood, Florida, United States, 33021 | |
| United States, Georgia | |
| Peachtree Hematology and Oncology | |
| Atlanta, Georgia, United States, 40202 | |
| Coastal Hematology & Oncology | |
| Savannah, Georgia, United States, 31406 | |
| United States, Idaho | |
| North Idaho Cancer Center | |
| Couer d'Alene, Idaho, United States, 83814 | |
| United States, Illinois | |
| Northshore Cancer Research Association | |
| Skokie, Illinois, United States, 60076 | |
| Midwest Cancer Research Group | |
| Skokie, Illinois, United States, 60077 | |
| Shelby D. Rifkin, M.D. | |
| Arlington Heights, Illinois, United States, 60004 | |
| Oncology Hematology Associates of Central Illinois, PC | |
| Peoria, Illinois, United States, 61602 | |
| Monroe Medical Associates | |
| Harvey, Illinois, United States, 60426 | |
| United States, Indiana | |
| Associated Physicians & Surgeons Clinic, L.L.C. | |
| Terre Haute, Indiana, United States, 47804 | |
| Hematology-Oncology of Indiana, PC | |
| Indianapolis, Indiana, United States, 46260 | |
| United States, Kentucky | |
| Norton Healthcare Pavilion | |
| Louisville, Kentucky, United States, 40202 | |
| Vijay Raghavan, M.D. | |
| Louisville, Kentucky, United States, 40215 | |
| Markey Clinical Oncology Research Program | |
| Lexington, Kentucky, United States, 40536-0098 | |
| United States, Louisiana | |
| LSU Medical Center | |
| New Orleans, Louisiana, United States, 70112 | |
| Tulane University Health Sciences Center | |
| New Orleans, Louisiana, United States, 70112 | |
| LSU Health Sciences Center | |
| Shreveport, Louisiana, United States, 71130-3932 | |
| Louisiana Oncology Associates | |
| Lafayette, Louisiana, United States, 70506 | |
| United States, Maine | |
| Maine Center for Cancer Medicine & Blood Disorders | |
| Scarborough, Maine, United States, 04074 | |
| United States, Maryland | |
| St. Agnes Healthcare, Inc. | |
| Baltimore, Maryland, United States, 21229-5299 | |
| Kaiser Permanente | |
| Rockville, Maryland, United States, 20850 | |
| United States, Michigan | |
| Spectrum Health -- Cook Research Dept. | |
| Grand Rapids, Michigan, United States, 49503 | |
| Josephine Ford Cancer Center | |
| Detroit, Michigan, United States, 48202 | |
| Hematology and Oncology Assoc. of Southern Mississippi | |
| Jackson, Michigan, United States, 48201 | |
| Providence Cancer Center | |
| Southfield, Michigan, United States, 48075 | |
| Genesys Hurley Cancer Institute | |
| Flint, Michigan, United States, 48503 | |
| Oncology Care Associates, PLLC | |
| St. Joseph, Michigan, United States, 49085 | |
| St. Joseph Mercy Hospital | |
| Ann Arbor, Michigan, United States, 48106-0995 | |
| United States, Minnesota | |
| SMDC Health System | |
| Duluth, Minnesota, United States, 55805 | |
| Minnesota CGOP | |
| Minneapolis, Minnesota, United States, 55407 | |
| Metro Minnesota CCOP | |
| St. Louis Park, Minnesota, United States, 55426 | |
| University of Minnesota Cancer Center | |
| Minneapolis, Minnesota, United States, 55455 | |
| United States, Missouri | |
| Heartland Hematology/Oncology Associates, Inc. | |
| Kansas City, Missouri, United States, 64118 | |
| Kansas City Oncology and Hematology Group | |
| Kansas City, Missouri, United States, 64131 | |
| Saint Louis University | |
| St. Louis, Missouri, United States, 63110 | |
| Missouri Cancer Care, PC | |
| St. Charles, Missouri, United States, 63301 | |
| Washington University School of Medicine | |
| St. Louis, Missouri, United States, 63110 | |
| Missouri Baptist Cancer Center | |
| St. Louis, Missouri, United States, 63131 | |
| Arch Medical Services Incorporated | |
| St. Louis, Missouri, United States, 63141 | |
| United States, Montana | |
| North Central Montana Professional Building | |
| Great Falls, Montana, United States, 59405 | |
| Montana Cancer Specialists | |
| Missoula, Montana, United States, 59807-7877 | |
| United States, Nebraska | |
| The Methodist Cancer Center | |
| Omaha, Nebraska, United States, 68114 | |
| 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 Jersey | |
| Hematology-Oncology Associates of New Jersey | |
| Morristown, New Jersey, United States, 07960 | |
| The Center for Cancer and Hematologic Disease | |
| Cherry Hill, New Jersey, United States, 08003 | |
| St. Barnabas Cancer Center | |
| Livingston, New Jersey, United States, 07039 | |
| Cooper Cancer Institute | |
| Voorhees, New Jersey, United States, 08043 | |
| Southern Oncology and Hematology Associates | |
| Vineland, New Jersey, United States, 08360 | |
| United States, New Mexico | |
| New Mexico Cancer Care | |
| Santa Fe, New Mexico, United States, 87505 | |
| United States, New York | |
| New York Oncology Hematology | |
| Latham, New York, United States, 12110 | |
| Cancer Research of Long Island | |
| Great Neck, New York, United States, 11023 | |
| Roswell Park Cancer Institute | |
| Buffalo, New York, United States, 14263 | |
| Broome Oncology | |
| Johnson City, New York, United States, 13790 | |
| Pluta Cancer Center | |
| Rochester, New York, United States, 14623 | |
| North Shore University Hospital | |
| Manhasset, New York, United States, 11030 | |
| Cancer Center at Nyack Hospital | |
| Nyack, New York, United States, 10960 | |
| CR Wood Cancer Center | |
| Glen Falls, New York, United States, 12801 | |
| United States, North Carolina | |
| Carolina Medical Center | |
| Charlotte, North Carolina, United States, 28203 | |
| United States, North Dakota | |
| Mid-Dakota Clinic PC | |
| Bismarck, North Dakota, United States, 58501 | |
| United States, Ohio | |
| Nashat Gabrail, M.D. | |
| Canton, Ohio, United States, 44718 | |
| Hematology Oncology Consultants, Inc. | |
| Columbus, Ohio, United States, 43235 | |
| Meridia Cancer Institute | |
| Mayfield Heights, Ohio, United States, 44124 | |
| Mid Ohio Oncology/Hematology, Inc. | |
| Columbus, Ohio, United States, 43213 | |
| United States, Oklahoma | |
| Cancer Care Associates | |
| Oklahoma City, Oklahoma, United States, 73112 | |
| Cancer Care Associates | |
| Tulsa, Oklahoma, United States, 74136-1929 | |
| United States, Oregon | |
| Kaiser Permanente Oncology Hematology | |
| Portland, Oregon, United States, 97227 | |
| United States, Pennsylvania | |
| Allegheny Cancer Center | |
| Pittsburgh, Pennsylvania, United States, 15212-4772 | |
| University of Pennsylvania Abramson Cancer Center | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Hershey Medical Center | |
| Hershey, Pennsylvania, United States, 17033 | |
| Monogahela Valley Hospital | |
| Monogahela, Pennsylvania, United States, 15063 | |
| 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 | |
| Charleston Hematology Oncology | |
| Charleston, South Carolina, United States, 29403 | |
| Spartanburg Regional Medical Center | |
| Spartanburg, South Carolina, United States, 29303 | |
| United States, Tennessee | |
| University of Tennessee Cancer Institute | |
| Memphis, Tennessee, United States, 38104 | |
| Sarah Cannon Cancer Center | |
| Nashville, Tennessee, United States, 37203 | |
| The Jones Clinic | |
| Germantown, Tennessee, United States, 38138 | |
| Baptist Regional Cancer Center | |
| Knoxville, Tennessee, United States, 37920 | |
| United States, Texas | |
| M.D. Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Southwest Regional Cancer Center | |
| Austin, Texas, United States, 78705 | |
| H. Alejandro Preti, MD, PA | |
| Houston, Texas, United States, 77030 | |
| Center for Oncology Research & Treatment, PA | |
| Dallas, Texas, United States, 75230 | |
| Scott & White Hospital | |
| Temple, Texas, United States, 76508 | |
| Oncology Consultants | |
| Houston, Texas, United States, 77024 | |
| Dr. Lee C. Drinkard | |
| Irving, Texas, United States, 75038 | |
| Corpus Christi Cancer Center | |
| Corpus Christi, Texas, United States, 78412 | |
| United States, Utah | |
| Utah Cancer Specialists | |
| Salt Lake City, Utah, United States, 84124 | |
| North Utah Associates | |
| Ogden, Utah, United States, 84403-3105 | |
| United States, Vermont | |
| Southwestern Vermont Health Care | |
| Bennington, Vermont, United States, 05201 | |
| United States, Virginia | |
| Northern Virginia Oncology Group | |
| Fairfax, Virginia, United States, 22031 | |
| Danville Hematology and Oncology, Inc. | |
| Danville, Virginia, United States, 24541 | |
| Cancer Treatment Centers of America | |
| Portsmouth, Virginia, United States, 23704 | |
| Virginia Cancer Institute | |
| Richmond, Virginia, United States, 23230 | |
| Virginia Oncology Associates | |
| Norfolk, Virginia, United States, 23502 | |
| United States, Washington | |
| Cascade Cancer Center | |
| Kirkland, Washington, United States, 98034 | |
| Western Washington Medical Group | |
| Everett, Washington, United States, 982901 | |
| Western Washington Medical Group | |
| Everett, Washington, United States, 98201 | |
| United States, Wisconsin | |
| UW Health -- University of Wisconsin Comp | |
| Madison, Wisconsin, United States, 53792 | |
| Waukesha Memorial Hospital | |
| Waukesha, Wisconsin, United States, 53188 | |
| Australia | |
| Garran, Australia, ACT 2605 | |
| Woolloongabba, Australia, QLD 4102 | |
| Wollongong, Australia, NSW 2500 | |
| Adelaide, Australia, SA 5000 | |
| Nedlands, Australia, WS 6009 | |
| Belgium | |
| Bruxelles, Belgium, 1200 | |
| Wilrijk, Belgium, 2610 | |
| Antwerpen, Belgium, 2020 | |
| Anderlecht, Belgium, 1070 | |
| Gent, Belgium, 9000 | |
| Brazil | |
| Sao Paulo, Brazil, 05651-901 | |
| Porto Alegre Rs, Brazil, 90020-090 | |
| Sao Paulo, Brazil, S01308-050 | |
| Porto Alegre, Brazil, CeP 90 610-000 | |
| Salvador, Brazil, BA 41825-010 | |
| Sao Paulo, Brazil, S01232-910 | |
| Canada, Ontario | |
| Toronto, Ontario, Canada | |
| Hamilton, Ontario, Canada | |
| Novartis Investigative Site | |
| Toronto, Ontario, Canada, M5G 2M9 | |
| Canada, Quebec | |
| Sainte-Foy, Quebec, Canada | |
| Czech Republic | |
| Praha 2, Czech Republic, 128 08 | |
| Brno, Czech Republic, 656 53 | |
| Praha 5, Czech Republic, 150 18 | |
| France | |
| Marseille Cedex 05, France, 13385 | |
| Strasbourg, France, 6700 | |
| Marseille Cedex 9, France, 13273 | |
| Germany | |
| Essen, Germany, 45122 | |
| Kiel, Germany, 24116 | |
| Hannover, Germany, 30625 | |
| Berlin, Germany, 14195 | |
| Frankfurt, Germany, 60488 | |
| Eschweiler, Germany, 52249 | |
| Erlangen, Germany, 91054 | |
| Leipzig, Germany, 4103 | |
| Berlin, Germany, 13353 | |
| Augsburg, Germany, 86150 | |
| Dessau, Germany, 6822 | |
| Heidelberg, Germany, 69115 | |
| Magdeburg, Germany, 39002 | |
| Köln, Germany, 50677 | |
| Hungary | |
| Gyor, Hungary, H-9002 | |
| Budapest, Hungary, H-1097 | |
| Budapest, Hungary, H-1032 | |
| Szeged, Hungary, H-6725 | |
| Italy | |
| Roma, Italy, 144 | |
| Roma, Italy, 135 | |
| Modena, Italy, 41100 | |
| Genova, Italy, 16132 | |
| Rozzano, Italy, 20089 | |
| Torino, Italy, 10126 | |
| Forli, Italy, 47100 | |
| Milano, Italy, 20162 | |
| Netherlands | |
| Ga Utrecht, Netherlands, 3508 | |
| New Zealand | |
| Novartis Investigative Site | |
| Hamilton, New Zealand | |
| Palmerston North, New Zealand | |
| Portugal | |
| Coimbra, Portugal, 3000-076 | |
| Slovakia | |
| Novartis Investigative Site | |
| Kosice, Slovakia, 041 90 | |
| Novartis Investigative Site | |
| Bratislava, Slovakia, 81250 | |
| Novartis Investigative Site | |
| Zilina, Slovakia, 012 07 | |
| Novartis Investigative Site | |
| Bratislava, Slovakia, 833 10 | |
| Spain | |
| Alicante, Spain, 3202 | |
| Madrid, Spain, 28035 | |
| Madrid, Spain, 28033 | |
| Malaga, Spain, 29010 | |
| Zaragoza, Spain, 50009 | |
| Madrid, Spain, 28041 | |
| Sweden | |
| Stockholm, Sweden, SE-118 83 | |
| Switzerland | |
| Bern, Switzerland, 3010 | |
| Zurich, Switzerland, 8027 | |
| Basel, Switzerland, 4031 | |
| Thun, Switzerland, 3600 | |
| Zürich, Switzerland, 8091 | |
| Taiwan | |
| Taipei, Taiwan | |
| Tao-Yuan, Taiwan | |
| Tainan, Taiwan | |
| United Kingdom | |
| Leicester, United Kingdom, LE1 5WW | |
| Belfast, United Kingdom, BT9 7AB | |
| Oxford, United Kingdom, OX3 7LJ | |
| Study Chair: | Novartis / Schering AG, Germany | Novartis / Schering AG, Germany |
More Information
| Responsible Party: | Novartis ( External Affairs ) |
| Study ID Numbers: | CPTK787 0135/306241, CONFIRM 1 |
| Study First Received: | March 13, 2003 |
| Last Updated: | November 18, 2009 |
| ClinicalTrials.gov Identifier: | NCT00056459 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Colorectal Cancer PTK787 Vatalanib VEGF inhibitor Oxaliplatin |
Angiogenesis Rectal Cancer Colon Cancer Colorectal Carcinoma 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 |
