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| Sponsor: | ImClone LLC |
|---|---|
| Collaborator: |
Bristol-Myers Squibb |
| Information provided by: | ImClone LLC |
| ClinicalTrials.gov Identifier: | NCT00063141 |
Purpose
The purpose of this study is to determine whether overall survival is prolonged in subjects with metastatic, epidermal growth factor receptor (EGFR)-positive colorectal cancer treated with cetuximab in combination with irinotecan compared with irinotecan alone as second-line therapy following treatment with a fluoropyrimidine and oxaliplatin based, non-irinotecan-containing regimen.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Cancer |
Drug: cetuximab Drug: Irinotecan |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Revised Protocol 07 to Protocol CA225006 - A Phase III Randomized, Open-Label, Multicenter Study of Irinotecan and Cetuximab vs. Irinotecan as Second-Line Treatment in Patients With Metastatic, EGFR-Positive Colorectal Carcinoma |
| Enrollment: | 1302 |
| Study Start Date: | April 2003 |
| Study Completion Date: | October 2007 |
| Primary Completion Date: | June 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Arm A: Experimental |
Drug: cetuximab
Vial, IV, 400 mg/m² week 1 then 250 mg/m², weekly, until PD/Toxicity/Pt-PI Decision
Drug: Irinotecan
Vial, IV, 350 mg/m², Q 3 Weeks, Until PD/Toxicity/Pt-PI Decision
|
| Arm B: Active Comparator |
Drug: Irinotecan
Vial, IV, 350 mg/m², Q 3 Weeks, Until PD/Toxicity/Pt-PI Decision
|
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, Arizona | |
| ACRC/Arizona Clinical Research Center | |
| Tucson, Arizona, United States, 85712 | |
| United States, Arkansas | |
| Arkansas Cancer Clinic, P.A. | |
| Pine Bluff, Arkansas, United States, 71603 | |
| United States, California | |
| California Cancer Care | |
| Greenbrae, California, United States, 95904 | |
| Compassionate Cancer Care Medical | |
| Corona, California, United States, 92708 | |
| South Valley Medical Plaza | |
| Gilroy, California, United States, 95020 | |
| Nerses Tchekmedyian, MD | |
| Long Beach, California, United States, 90813 | |
| Tower Hematology/Oncology | |
| Beverly Hills, California, United States, 90211 | |
| Cancer and Blood Institute of the Desert | |
| Rancho Mirage, California, United States, 92270 | |
| Comprehensive Blood and Cancer Center | |
| Bakersfield, California, United States, 93309 | |
| Kaiser Permanente Medical Center | |
| Vallejo, California, United States, 94589 | |
| Oncology Care Medical Associates | |
| Montebello, California, United States, 90640 | |
| Metropolitan Hematology/Oncology Medical Center | |
| Los Angeles, California, United States, 90057 | |
| Comprehensive Cancer Center | |
| Palm Springs, California, United States, 92262 | |
| USC/Norris Comprehensive Cancer Center | |
| Los Angeles, California, United States, 90033 | |
| Alta Bates Comprehensive Cancer Center | |
| Berkeley, California, United States | |
| Southern California Permanente Medical Group | |
| San Diego, California, United States | |
| Stockton Hem/Onc Med Group | |
| Stockton, California, United States, 95204 | |
| Medical Oncology Care Associates | |
| Orange, California, United States, 92868 | |
| United States, Colorado | |
| Rocky Mountain Cancer Center-Midtown | |
| Denver, Colorado, United States, 80218 | |
| Rocky Mountain Cancer Center - Aurora | |
| Aurora, Colorado, United States, 80012 | |
| United States, Connecticut | |
| Hematology Oncology, P.C. | |
| Stamford, Connecticut, United States, 06902 | |
| Yale University School of Medicine | |
| New Haven, Connecticut, United States, 06520 | |
| Eastern CT Hematology Oncology Associates | |
| Norwich, Connecticut, United States, 06360 | |
| Oncology & Hematology Associates, PC | |
| New London, Connecticut, United States, 06320 | |
| United States, Florida | |
| Integrated Community Oncology Network | |
| Jacksonville, Florida, United States, 32207 | |
| Hematology-Oncology Associates | |
| Port St. Lucie, Florida, United States, 34952 | |
| Watson Clinic, LLP Center for Cancer Care & Research | |
| Lakeland, Florida, United States, 33805 | |
| University of Miami School of Medicine | |
| Miami, Florida, United States, 33136 | |
| Mayo Clinic Jacksonville | |
| Jacksonville, Florida, United States, 32224 | |
| Florida Cancer Specialist | |
| Fort Myers, Florida, United States, 33901 | |
| Florida Cancer Specialists | |
| Fort Myers, Florida, United States, 33990 | |
| Nature Coast Clinical Research, LLC | |
| Inverness, Florida, United States, 34452 | |
| Pasco Hernando Oncology | |
| New Port Richey, Florida, United States, 34652 | |
| University of Florida Health Science Center/Jacksonville | |
| Jacksonville, Florida, United States, 32209 | |
| MD Anderson Cancer Center Orlando | |
| Orlando, Florida, United States, 32806 | |
| Lakeland Regional Cancer Center | |
| Lakeland, Florida, United States, 33805 | |
| United States, Georgia | |
| Peachtree Hematology and Oncology | |
| Atlanta, Georgia, United States, 30309 | |
| Central Georgia Hematology and Oncology | |
| Macon, Georgia, United States, 31201 | |
| Georgia Cancer Specialist | |
| Tucker, Georgia, United States, 30342 | |
| Summit Care Center | |
| Savannah, Georgia, United States, 31405 | |
| The Medical Center | |
| Columbus, Georgia, United States, 31902-0951 | |
| Winship Cancer Institute | |
| Atlanta, Georgia, United States, 30322 | |
| United States, Hawaii | |
| Hawaii Pacific Health Research Institute | |
| Honolulu, Hawaii, United States | |
| United States, Illinois | |
| Edward Cancer Center | |
| Naperville, Illinois, United States, 60540 | |
| United States, Indiana | |
| Michiana Hematology Oncology, P.C. | |
| South Bend, Indiana, United States, 46601 | |
| United States, Kansas | |
| University of Kansas Medical Center | |
| Kansas City, Kansas, United States, 66160 | |
| Kansas City Cancer Centers | |
| Overland Park, Kansas, United States, 66214 | |
| United States, Kentucky | |
| University of Kentucky | |
| Lexington, Kentucky, United States, 40536-0098 | |
| Kentuckiana Cancer Institute, PLLC | |
| Louisville, Kentucky, United States, 40202 | |
| Commonwealth Cancer Center of Richmond | |
| Richmond, Kentucky, United States | |
| United States, Louisiana | |
| Hematology/Oncology Clinic | |
| Baton Rouge, Louisiana, United States, 70808 | |
| Oncology and Hematology | |
| Metairie, Louisiana, United States, 70006 | |
| LSU Health Sciences Center | |
| Shreveport, Louisiana, United States, 71103 | |
| Louisiana Oncology Associates | |
| Lafayette, Louisiana, United States, 70506 | |
| United States, Maryland | |
| Greater Baltimore Medical Center | |
| Baltimore, Maryland, United States, 21204 | |
| Frederick Memorial Hospital Regional | |
| Frederick, Maryland, United States, 21701 | |
| United States, Massachusetts | |
| Caritas St. Elizabeth's Medical Center | |
| Boston, Massachusetts, United States | |
| United States, Michigan | |
| St. Joseph Mercy Hospital Cancer Care Center | |
| Ann Arbor, Michigan, United States, 48106 | |
| Providence Cancer Center | |
| Southfield, Michigan, United States, 48075 | |
| Karmanos Cancer Research | |
| Detroit, Michigan, United States, 48201 | |
| United States, Minnesota | |
| Metro Minnesota CCOP | |
| St. Louis Park, Minnesota, United States, 55426 | |
| Virginia Piper Cancer Institute | |
| Minneapolis, Minnesota, United States, 55407-3799 | |
| Hubert H. Humphrey Cancer Center | |
| Robbinsdale, Minnesota, United States, 55422 | |
| United States, Mississippi | |
| Jackson Oncology Associates | |
| Jackson, Mississippi, United States, 39202 | |
| United States, Missouri | |
| Kansas City Cancer Centers, Llc. | |
| Kansas City, Missouri, United States, 64111 | |
| Washington University Medical Center | |
| St. Louis, Missouri, United States, 63110 | |
| Bond Clinic, Inc. | |
| Rolla, Missouri, United States, 65401 | |
| United States, New Jersey | |
| CINJ at Cooper University Hospital | |
| Voorhees, New Jersey, United States, 08084 | |
| The Cancer Inst of NJ at Hamilton | |
| Trenton, New Jersey, United States, 08690 | |
| United States, New York | |
| New York Oncology Hematology | |
| Rexford, New York, United States, 12148 | |
| New York Medical College/Westchester | |
| Valhalla, New York, United States, 10595 | |
| New York Oncology Hematology Associates | |
| Albany, New York, United States, 12208 | |
| Our Lady of Mercy Hospital | |
| Bronx, New York, United States, 10466 | |
| Suny @ Stony Brook | |
| Stony Brook, New York, United States, 11794 | |
| New York University Clinical Cancer Institute | |
| New York, New York, United States, 10016 | |
| New York Oncology Hematology | |
| Latham, New York, United States, 12110 | |
| Winthrop University Hospital | |
| Mineola, New York, United States, 11501 | |
| North Shore Hematology Oncology | |
| East Setauket, New York, United States, 11733 | |
| United States, North Carolina | |
| Raleigh Hematology Oncology Associates, Wake Practice | |
| Raleigh, North Carolina, United States, 27609 | |
| Piedmont Hematology Oncology Associates | |
| Winston-Salem, North Carolina, United States, 27103 | |
| Emerywood Hematology and Oncology | |
| High Point, North Carolina, United States | |
| Physician's East PA | |
| Greenville, North Carolina, United States, 27834 | |
| Duke University Medical Center | |
| Durham, North Carolina, United States, 27710 | |
| East Carolina University School of Medicine | |
| Greenville, North Carolina, United States | |
| Wake Forest University Health Sciences | |
| Winston-Salem, North Carolina, United States, 27157 | |
| United States, North Dakota | |
| Mid Dakota Clinic | |
| Bismarck, North Dakota, United States, 58501 | |
| United States, Ohio | |
| Hematology Oncology Consultants | |
| Columbus, Ohio, United States, 43235 | |
| Hematology Oncology Consultants Inc | |
| Newark, Ohio, United States, 43055 | |
| Medical Oncology Hematology Associates | |
| Dayton, Ohio, United States, 45459 | |
| University of Cincinnati Barrett Cancer Center | |
| Cincinnati, Ohio, United States, 45267 | |
| Case Western Reserve University | |
| Cleveland, Ohio, United States, 44106 | |
| United States, Oklahoma | |
| Cancer Specialists of Oklahoma | |
| Oklahoma City, Oklahoma, United States | |
| United States, Pennsylvania | |
| Hershey Medical Center | |
| Hershey, Pennsylvania, United States, 17033 | |
| Pennsylvania Oncology/Hematology Associates | |
| Philadelphia, Pennsylvania, United States, 19106 | |
| Albert Einstein Cancer Center | |
| Philadelphia, Pennsylvania, United States, 19141-3098 | |
| Jefferson Medical College | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| Hillman Cancer Center | |
| Pittsburgh, Pennsylvania, United States, 15232 | |
| United States, South Carolina | |
| Cancer Centers of the Carolinas | |
| Greenville, South Carolina, United States, 29615 | |
| United States, Tennessee | |
| Thompson Cancer Survival Center | |
| Knoxville, Tennessee, United States, 37916 | |
| The West Clinic, P.C. | |
| Memphis, Tennessee, United States, 38120 | |
| The Sarah Cannon Cancer Center | |
| Nashville, Tennessee, United States, 37203 | |
| United States, Texas | |
| Center for Oncology Research and Treatment | |
| Dallas, Texas, United States, 75230 | |
| Lone Star Oncology Consultants | |
| Austin, Texas, United States, 78759 | |
| Scott & White Memorial Hospital | |
| Temple, Texas, United States, 76508 | |
| North Texas Regional Cancer Center | |
| Plano, Texas, United States, 75075 | |
| Texas Cancer Center at Medical City | |
| Dallas, Texas, United States, 75230 | |
| Department of Gastrointestinal Medical Oncology | |
| Houston, Texas, United States, 77030 | |
| United States, Utah | |
| Northern Utah Associates | |
| Ogden, Utah, United States, 84403 | |
| United States, Virginia | |
| Danville Hematology and Oncology Inc. | |
| Danville, Virginia, United States, 24541 | |
| Arlington-Fairfax Hematology Oncology | |
| Arlington, Virginia, United States, 22205 | |
| Virginia Oncology Associates | |
| Newport News, Virginia, United States, 23606 | |
| Virginia Cancer Institute | |
| Richmond, Virginia, United States, 23230 | |
| United States, Washington | |
| Cancer Care Northwest | |
| Spokane, Washington, United States, 99218 | |
| St. Mary Medical Center St. Mary Regional Cancer Center | |
| Walla Walla, Washington, United States, 99362 | |
| Swedish Medical Center | |
| Seattle, Washington, United States, 98104 | |
| Medical Oncology Associates | |
| Spokane, Washington, United States, 99204 | |
| United States, Wisconsin | |
| Froedtert Memorial Lutheran Hospital/Clinic | |
| Milwaukee, Wisconsin, United States, 53226 | |
| University of Wisconsin Hospital and Clinics | |
| Madison, Wisconsin, United States, 53792 | |
| Green Bay Oncology, Ltd/St. Vincent Hospital | |
| Green Bay, Wisconsin, United States, 54301 | |
| Australia | |
| Wilhelminenspital Der Stadt Wien | |
| Wien, Australia | |
| Australia, Australian Capital Territory | |
| Prince of Wales Hospital | |
| Sydney, Australian Capital Territory, Australia | |
| Mount Medical Centre, Perth Oncology | |
| Perth, Australian Capital Territory, Australia | |
| Australia, New South Wales | |
| Southern Medical Day Care, Med Onc | |
| Wollongong, New South Wales, Australia | |
| Sydney Cancer Centre | |
| Sydney, New South Wales, Australia | |
| St. Vincent's Hospital | |
| Sydney, New South Wales, Australia | |
| Australia, Queensland | |
| Mater Adult Hospital | |
| South Brisbane, Queensland, Australia | |
| Australia, South Australia | |
| The Queen Elizabeth Hospital | |
| Adelaide, South Australia, Australia | |
| Flinders Medical Centre | |
| Adelaide, South Australia, Australia | |
| Austria | |
| Universitatsklinik Fur Innere Medizin I | |
| Wein, Austria | |
| Krankenhaus Der Stadt Wien Rudolfstiftung | |
| Wien, Austria | |
| Krankenh aus Der Stadt Wien Lainz | |
| Wein, Austria | |
| Donauspital Im Smz-Ost Der Stadt Wien | |
| Wien, Austria | |
| Medizinische Universitatsklinik | |
| Graz, Austria | |
| St. Johanns Spital-Landeskrankenhaus | |
| Salzburg, Austria | |
| Belgium | |
| Centre Hospitalier Notre-Dame-Reine Fabiola | |
| Charleroi, Belgium | |
| Czech Republic | |
| Fakultini Nemocnice V Motole | |
| Praha 5, Czech Republic | |
| Clinical Trials Unit | |
| Brno, Czech Republic | |
| Fakultni Nemocnice Olomouc | |
| Olomouc, Czech Republic | |
| Finland | |
| Eira Hospital | |
| Helsinki, Finland | |
| France | |
| Centre Rene Gauducheau, Site Hospitalier Nord | |
| Saint Herblain, France | |
| Hopital Jean Minjoz | |
| Saint Herblain, France | |
| Institut Paoli-Calmettes | |
| Marseille, France | |
| Centre Antoine Lacassagne | |
| Nice, France | |
| Institut Sainte Catherine | |
| Avignon, France | |
| Germany | |
| Robert-Bosch-Krankenhaus Stuttgart | |
| Stuttgart, Germany | |
| Krankenhaus Munchen-Bogenhausen | |
| Munchen, Germany | |
| Westpfalz-Klinkum Gmbh | |
| Kaiserslautern, Germany | |
| Medizinische Klinik Mitte | |
| Dortmund, Germany | |
| Fakultaet F.Klin.Med. Mannheim | |
| Mannheim, Germany | |
| Stadtisches Klinikum Magdeburg Krankenhaus Alstadt | |
| Magdeburg, Germany | |
| Gemeinschaftspraxis Hamatologie/Onkologie | |
| Magdeburg, Germany | |
| Klinikum Der Hansestadt Stralsund Gmbh | |
| Stralsund, Germany | |
| Caritasklinik St. Theresia/Saarbrucken | |
| Saarbrucken, Germany | |
| Universitatsklinik Mainz | |
| Mainz, Germany | |
| Stadtisches Klinikum Dessau | |
| Dessau, Germany | |
| Univ Munchen-Grosshadern | |
| Munchen, Germany | |
| Klinikum Kassel | |
| Kassel, Germany | |
| Universitatsklinikum Essen | |
| Essen, Germany | |
| Klinikum Augsburg | |
| Augsburg, Germany | |
| Facharzt Fur Innere Medizin | |
| Muchnhen, Germany | |
| Weissenbaurger Strasse 28 | |
| Aschaffenburg, Germany | |
| Klinikum Der Univ. Regensburg | |
| Regensburg, Germany | |
| Marienkrankenhaus Hamburg | |
| Hamburg, Germany | |
| Innovation Onkologie Res and Consulting-Gmbh (Iorc) | |
| Hanburg, Germany | |
| Hong Kong | |
| Prince of Wales Hospital | |
| Hong Kong, Hong Kong | |
| Italy | |
| Az Osp S Martino Genova Univ Conv | |
| Genova, Italy | |
| Universita Cattolica | |
| Roma, Italy | |
| Universita Napoli Federico Ii | |
| Napoli, Italy | |
| Azienda Ospedaliera S. Maria Nuova | |
| Reggio Emilia, Italy | |
| Clinica Di Oncologica Medica, Ospedale Regionale Torrette | |
| Ancona, Italy | |
| Universita Di Napoli | |
| Napoli, Italy | |
| Instituto Regina Elena | |
| Rome, Italy | |
| Azienda Ospedaliera Policlinico De Modena | |
| Modena, Italy | |
| Azienda Ospedaliera Careggi | |
| Firenze, Italy | |
| Azienda San Locale N6 Presido Ospedaliero Di Livomo | |
| Livomo, Italy | |
| Azienda Ospedaliera Ospedali Riuniti Bergamo | |
| Bergamo, Italy | |
| Ospedale Niguarda CaGranda | |
| Milano, Italy | |
| Istituto Per La Ricerca E La Cura Del Cancro | |
| Candiolo, Italy | |
| Pol Monteluce Az Ops Di Perugia | |
| Perugia, Italy | |
| Italy, Milano | |
| Divisione Di Oncologia Medica Via Manzoni, 56 | |
| Rozzano, Milano, Italy | |
| Netherlands | |
| Albert Schweitzer Hospital, Locatie Dordwijk | |
| Dordrecht, Netherlands | |
| Geire Ziekenhuis Locatie Lukas | |
| Apeldorn, Netherlands | |
| Norway | |
| Ullevals Hospital | |
| Oslo, Norway | |
| Norway, Oslo | |
| Det Norske Radiumhospitalet Hf | |
| Montebello, Oslo, Norway | |
| Portugal | |
| Institutio Portugues De Oncologia | |
| Porto, Portugal | |
| Slovakia | |
| National Cancer Institute | |
| Bratislava, Slovakia | |
| Onkologicky Ustav Sv. Alzbety, S.R.O. | |
| Bratislava, Slovakia | |
| Sweden | |
| University Hospital | |
| Lund, Sweden | |
| Karolinska Hospital | |
| Stockholm, Sweden | |
| Switzerland | |
| Inselpital | |
| Bern, Switzerland | |
| Stadtspital Triemli | |
| Zurich, Switzerland | |
| Universitatsspital Zurich | |
| Zurich, Switzerland | |
| Kantonsspital | |
| Zurich, Switzerland | |
| Kantonsspital Liestal | |
| Liestal, Switzerland | |
| Birmensdorferstrasse 497 | |
| Zurich, Switzerland | |
| United Kingdom, Aberdeenshire | |
| Aberdeen Royal Infirmary | |
| Foresterhill, Aberdeenshire, United Kingdom | |
| United Kingdom, Avon | |
| Princess Royal Hospital | |
| Hull, Avon, United Kingdom | |
| United Kingdom, Central | |
| Beatson Oncology Ctr Glasgow | |
| Glasgow, Central, United Kingdom | |
| United Kingdom, Dorset | |
| Poole General Hospital | |
| Poole, Dorset, United Kingdom | |
| United Kingdom, Greater London | |
| Guys Hospital | |
| London, Greater London, United Kingdom | |
| United Kingdom, Hampshire | |
| The Royal Bournemouth Hospital Trust | |
| Bournemouth, Hampshire, United Kingdom | |
| United Kingdom, Surrey | |
| Royal Marsden Hospital | |
| Sutton, Surrey, United Kingdom | |
| Royal Surrey Country Hospital | |
| Guildford, Surrey, United Kingdom | |
| Study Director: | ImClone Systems | ImClone LLC |
More Information
| Responsible Party: | ImClone Systems ( Eric Rowinsky, Chief Medical Officer ) |
| Study ID Numbers: | CA225-006 |
| Study First Received: | June 20, 2003 |
| Last Updated: | August 18, 2009 |
| ClinicalTrials.gov Identifier: | NCT00063141 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Digestive System Neoplasms Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Gastrointestinal Diseases Colonic Diseases Irinotecan Cetuximab Enzyme Inhibitors Intestinal Diseases Rectal Diseases |
Pharmacologic Actions Intestinal Neoplasms Neoplasms Neoplasms by Site Digestive System Diseases Therapeutic Uses Gastrointestinal Neoplasms Antineoplastic Agents, Phytogenic Colorectal Neoplasms |
