Irinotecan With or Without Oxaliplatin in Treating Patients With Metastatic Colorectal Cancer
2013년 12월 18일 업데이트: Sanofi
A Multicenter, Open-Label, Randomized, Two-Arm Study of Irinotecan (CPT-11) Versus the Combination of Oxaliplatin + Irinotecan (CPT-11) as Second-Line Treatment of Metastatic Colorectal Carcinoma
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if irinotecan is more effective with or without oxaliplatin in treating metastatic colorectal cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of irinotecan with or without oxaliplatin in treating patients who have metastatic colorectal cancer.
연구 개요
상세 설명
OBJECTIVES:
- Compare the overall survival of patients with metastatic colorectal cancer treated with irinotecan with or without oxaliplatin.
- Compare the response rate, time to tumor-related worsening of symptoms, time to disease progression, onset and duration of responses, and duration of disease stabilization in these patients treated with these regimens.
- Compare the safety of these regimens in these patients.
OUTLINE: This is a randomized, open label, multicenter study. Patients are stratified according to Karnofsky performance status (50-60% vs 70-100%), number of metastatic organs involved (1 vs 2 or more), lactic dehydrogenase (no greater than 1.5 times upper limit of normal (ULN) vs greater than 1.5 times ULN), and prior fluorouracil chemotherapy (adjuvant vs first-line treatment for metastatic disease). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive irinotecan IV over 90 minutes on day 1.
- Arm II: Patients receive oxaliplatin IV over 120 minutes followed by irinotecan IV over 30 minutes on day 1.
Courses repeat in each arm every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity.
Patients are followed at 30 days, every 4 weeks for 3 months, and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 596 patients (298 per arm) will be accrued for this study within 18 months.
연구 유형
중재적
단계
- 3단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Alabama
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Huntsville, Alabama, 미국, 35801
- Comprehensive Cancer Institute of Huntsville
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Mobile, Alabama, 미국, 36688
- Oncology Center at Providence Park
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Arizona
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Tucson, Arizona, 미국, 85712
- Arizona Clinical Research Center
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California
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Covina, California, 미국, 91722
- Citrus Valley Medical Center
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Greenbrae, California, 미국, 94904-2007
- California Cancer Care, Inc.
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Los Angeles, California, 미국, 90057
- Kenmar Research Institute
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Los Angeles, California, 미국, 90048
- Tower Hematology Oncology Medical Group
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Los Angeles, California, 미국, 90067
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Orange, California, 미국, 92868
- Medical Oncology Care Associates
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Oxnard, California, 미국, 93030
- P.M.K. Medical Group, Inc.
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Rancho Mirage, California, 미국, 92270
- Cancer and Blood Institute of the Desert
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San Diego, California, 미국, 92120
- Kaiser Permanente-Southern California Permanente Medical Group
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Santa Monica, California, 미국, 90404
- John Wayne Cancer Institute
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Vallejo, California, 미국, 94589
- Kaiser Permanente Medical Center - Vallejo
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Colorado
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Denver, Colorado, 미국, 80218
- Rocky Mountain Cancer Center
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Denver, Colorado, 미국, 80205
- Colorado Permanente Medical Group, P.C.
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Denver, Colorado, 미국, 80220
- University of Colorado Cancer Center
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Connecticut
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Norwalk, Connecticut, 미국, 06856
- Whittingham Cancer Center
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District of Columbia
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Washington, District of Columbia, 미국, 20037
- George Washington University Medical Center
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Florida
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Boca Raton, Florida, 미국, 33428
- Comprehensive Cancer Care Specialists of Boca Raton
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Boca Raton, Florida, 미국, 33486
- Center for Hematology-Oncology
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Fort Lauderdale, Florida, 미국, 33308
- Southeast Florida Hematology-Oncology Group
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Fort Myers, Florida, 미국, 33901
- Florida Cancer Specialists
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Gainesville, Florida, 미국, 32610-100277
- Shands Hospital and Clinics, University of Florida
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Jacksonville, Florida, 미국, 32209
- University of Florida Health Science Center - Jacksonville
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Jacksonville, Florida, 미국, 32207
- Hematology and Oncology Associates of Jacksonville
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Lakeland, Florida, 미국, 33804
- Lakeland Regional Medical Center
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Leesburg, Florida, 미국, 34748
- Lake Heart and Cancer Medical Center
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Miami, Florida, 미국, 33176
- Oncology-Hematology Group of South Florida
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Orlando, Florida, 미국, 32804
- Hematology and Oncology Consultants, P.A.
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Port Saint Lucie, Florida, 미국, 34952
- Hematology/Oncology Associates
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Tamarac, Florida, 미국, 33321
- Oncology & Hematology Associates of West Broward
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Tampa, Florida, 미국, 33613
- University Community Hospital
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Titusville, Florida, 미국, 32796
- Hematology and Oncology Consultants
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Idaho
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Coeur d'Alene, Idaho, 미국, 83814
- North Idaho Cancer Center
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Illinois
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Arlington Heights, Illinois, 미국, 60004
- Northwest Medical Specialists, P.C.
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Aurora, Illinois, 미국, 60506
- Dreyer Medical Clinic
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Chicago, Illinois, 미국, 60611
- Northwestern Medical Faculty Foundation
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Indiana
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New Albany, Indiana, 미국, 47150
- Cancer Care Center
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Kentucky
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Lexington, Kentucky, 미국, 40536-0084
- Albert B. Chandler Medical Center, University of Kentucky
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Louisville, Kentucky, 미국, 40202
- James Graham Brown Cancer Center
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Louisville, Kentucky, 미국, 40202
- Kentuckiana Cancer Institute
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Louisville, Kentucky, 미국, 40202
- Norton Healthcare Pavilion
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Louisville, Kentucky, 미국, 40206
- Veterans Affairs Medical Center - Louisville
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Louisiana
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Baton Rouge, Louisiana, 미국, 70806
- Baton Rouge General Medical Center
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Lafayette, Louisiana, 미국, 70506
- Louisiana Oncology Associates
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Metairie, Louisiana, 미국, 70006
- Doctors Hospital of Jefferson
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New Orleans, Louisiana, 미국, 70112
- Stanley Scott Cancer Center
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Maryland
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Baltimore, Maryland, 미국, 21204
- Greater Baltimore Medical Center and Cancer Center
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Massachusetts
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Boston, Massachusetts, 미국, 02120
- Medical Center of Boston
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Pittsfield, Massachusetts, 미국, 01201
- Berkshire Hematology Oncology, P.C.
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Michigan
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Detroit, Michigan, 미국, 48201-1379
- Barbara Ann Karmanos Cancer Institute
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Flint, Michigan, 미국, 48532
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Minnesota
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Roseville, Minnesota, 미국, 55113
- Parker Hughes Cancer Center
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Mississippi
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Jackson, Mississippi, 미국, 39202
- Jackson Oncology Associates, PLLC
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Missouri
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Kansas City, Missouri, 미국, 64128
- Veterans Affairs Medical Center - Kansas City
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Saint Louis, Missouri, 미국, 63110
- Siteman Cancer Center
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Saint Louis, Missouri, 미국, 63141
- St. John's Mercy Medical Center
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St. Charles, Missouri, 미국, 63301
- Missouri Cancer Care, P.C.
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Montana
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Great Falls, Montana, 미국, 59405
- Great Falls Clinic
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Missoula, Montana, 미국, 59807-7609
- Western Montana Clinic
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New Jersey
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Somerville, New Jersey, 미국, 08876
- Somerset Medical Center
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Voorhees, New Jersey, 미국, 08043
- Cooper Cancer Institute
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New York
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Albany, New York, 미국, 12208
- Veterans Affairs Medical Center - Albany
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Bronx, New York, 미국, 10467-2490
- Montefiore Medical Center
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Fresh Meadows, New York, 미국, 11365
- Queens Medical Associates, PC
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Jamaica, New York, 미국, 11432
- Queens Hospital Center
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Rochester, New York, 미국, 14623
- Interlakes Oncology/Hematology PC
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Valhalla, New York, 미국, 10595
- New York Medical College
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North Carolina
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Chapel Hill, North Carolina, 미국, 27599-7295
- Lineberger Comprehensive Cancer Center, UNC
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Raleigh, North Carolina, 미국, 27609
- Raleigh Hematology/Oncology Associates - Wake Practice
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Winston-Salem, North Carolina, 미국, 27103
- Piedmont Hematology-Oncology Associates
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Ohio
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Cleveland, Ohio, 미국, 44195
- Cleveland Clinic Taussig Cancer Center
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Columbus, Ohio, 미국, 43235
- Hematology Oncology Consultants Inc
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Oregon
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Bend, Oregon, 미국, 97701
- Bend Memorial Clinic
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Portland, Oregon, 미국, 97227
- Kaiser Permanente - Portland
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Pennsylvania
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Harrisburg, Pennsylvania, 미국, 17105-8700
- Pinnacle Health Hospitals
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Meadowbrook, Pennsylvania, 미국, 18974
- Abington Hematology Oncology Associates, Incorporated
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Philadelphia, Pennsylvania, 미국, 19104
- University of Pennsylvania Cancer Center
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Philadelphia, Pennsylvania, 미국, 19106
- Pennsylvania Oncology Hematology Associates
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Pittsburgh, Pennsylvania, 미국, 15213
- University of Pittsburgh Cancer Institute
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Rhode Island
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Providence, Rhode Island, 미국, 02906
- Lifespan: The Miriam Hospital
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South Carolina
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Greenville, South Carolina, 미국, 29615
- Cancer Centers of the Carolinas
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Greenville, South Carolina, 미국, 27834
- Physicians East - Quadrangle
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Tennessee
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Chattanooga, Tennessee, 미국, 37403
- Erlanger Health Systems
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Knoxville, Tennessee, 미국, 37901
- Baptist Regional Cancer Center - Knoxville
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Memphis, Tennessee, 미국, 38119
- Memphis Cancer Center
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Memphis, Tennessee, 미국, 38117
- West Clinic
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Nashville, Tennessee, 미국, 37232-6307
- Vanderbilt-Ingram Cancer Center
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Nashville, Tennessee, 미국, 37205
- Tennessee Oncology, P.L.L.C.
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Texas
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Austin, Texas, 미국, 78759
- Lone Star Oncology
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Dallas, Texas, 미국, 75230
- Center for Oncology Research and Treatment, Medical City Hospital
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San Antonio, Texas, 미국, 78205
- Baptist Health System Cancer Program
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Utah
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Salt Lake City, Utah, 미국, 84112
- Huntsman Cancer Institute
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Virginia
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Charlottesville, Virginia, 미국, 22908
- Cancer Center at the University of Virginia
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Fredericksburg, Virginia, 미국, 22401
- Hematology-Oncology Associates of Frederiksburg, Inc.
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Washington
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Seattle, Washington, 미국, 98101
- Virginia Mason Medical Center
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Wisconsin
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Milwaukee, Wisconsin, 미국, 53209
- Advanced Health Care
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Wausau, Wisconsin, 미국, 54401
- UW Cancer Center Wausau Hospital
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Wyoming
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Laramie, Wyoming, 미국, 82070
- Irving Cancer Center
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Aracaiu-SE, 브라질, CEP: 49094-970
- Hospital Joao Alves Fiho
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Belo Horizonte-MG, 브라질, CEP: 30180-060
- Hospital Socor
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Curitiba-PR, 브라질, CEP: 81520-060
- Hospital Erastos Gaertner
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Rio de Janeiro, 브라질, 20230-130
- Instituto Nacional de Cancer
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Rio de Janeiro, 브라질, CEP: 22260-020
- Oncologistas Associados
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Sao Paulo, 브라질, CEP: 01509-010
- Hospital do Cancer A C Comargo
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Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, 브라질, 90035-003
- Porto Alegre Hospital
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Sao Paulo
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Sorocaba, Sao Paulo, 브라질, 18030-200
- Instituto de Oncologia de Soracaba
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England
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Guildford, England, 영국, GU2 5XX
- St. Luke's Cancer Center
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London, England, 영국, SE1 9RT
- Guy's and St. Thomas' Hospitals NHS Trust
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London, England, 영국, W6 8RF
- Charing Cross Hospital
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London, England, 영국, EC1A 7BE
- St. Bartholomew's Hospital
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Maidstone, England, 영국, ME16 9QQ
- Maidstone Hospital
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Manchester, England, 영국, M20 4BX
- Christie Hospital N.H.S. Trust
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Plymouth, England, 영국, PL6 8DH
- Derriford Hospital
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Sheffield, England, 영국, S1O 2SJ
- Weston Park Hospital
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Sutton, England, 영국, SM2 5PT
- Royal Marsden Hospital
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Scotland
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Aberdeen, Scotland, 영국, AB25 2ZN
- Aberdeen Royal Infirmary
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Ceske Budejovice, 체코 공화국, 370 01
- Centre of Clinical Oncology and Radiation Oncology
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Hradec Kralove, 체코 공화국, 500 02
- Charles University Hospital
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Prague, 체코 공화국, 128 08
- Onkologicka Klinka A Onkologicka Lab
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Praha, 체코 공화국, 150 06
- Fakultni nemocnice v Motole
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St. Jerome Quebec, 캐나다, JYZ 5T3
- Zoom International Incoporated
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Alberta
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Calgary, Alberta, 캐나다, T2N 4N2
- Tom Baker Cancer Center - Calgary
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Edmonton, Alberta, 캐나다, T6G 2R7
- University of Alberta
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Nova Scotia
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Halifax, Nova Scotia, 캐나다, B3H 1V7
- Nova Scotia Cancer Centre
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Ontario
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Barrie, Ontario, 캐나다, L4M 6M2
- Royal Victoria Hospital, Barrie
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London, Ontario, 캐나다, N6A 4L6
- Cancer Care Ontario-London Regional Cancer Centre
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Ottawa, Ontario, 캐나다, K1H 1C4
- Ottawa Regional Cancer Centre
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Sudbury, Ontario, 캐나다, P3E 5J1
- Northeastern Ontario Regional Cancer Centre, Sudbury
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Toronto, Ontario, 캐나다, M4N 3M5
- Toronto Sunnybrook Regional Cancer Centre
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Toronto, Ontario, 캐나다, M5G 1X5
- Mount Sinai Hospital - Toronto
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Toronto, Ontario, 캐나다, M5G 2M9
- Princess Margaret Hospital
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Quebec
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Greenfield Park, Quebec, 캐나다, J4V 2H1
- Hôpital Charles LeMoyne
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Laval, Quebec, 캐나다, H7M 3L9
- Cité de la Santé de Laval
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Levis, Quebec, 캐나다, G6V 3Z1
- L'Hotel Dieu de Levis
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Montreal, Quebec, 캐나다, H1T 2M4
- Maisonneuve-Rosemont Hospital
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Montreal, Quebec, 캐나다, H4J 1C5
- Hôpital du Sacré-Cœur de Montréal
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Montreal, Quebec, 캐나다, H3T 1E2
- Jewish General Hospital - Montreal
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Quebec City, Quebec, 캐나다, G1R 2J6
- Centre Hospitalier Universitaire de Quebec
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Sainte Foy, Quebec, 캐나다, GIV 4G2
- Centre Hospitalier de L'Universitaire de Quebec, Pavillon CHUL
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Ste-Foy, Quebec, 캐나다, G1V 4G5
- L'Hopital Laval
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Saskatchewan
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Saskatoon, Saskatchewan, 캐나다, S7N 4H4
- Saskatoon Cancer Centre
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Gliwice, 폴란드, 44-101
- Maria S. Curie Memorial Institute
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Krakow (Cracow), 폴란드, 31-826
- Jagiellonian University
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Lodz, 폴란드, 93509
- Institute of Oncology
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Poznan, 폴란드, 61-866
- Wielkopolskie Centrum Onkologii Oddzial Chemioterapii
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Budapest, 헝가리, 1125
- National Institute of Oncology
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Budapest, 헝가리, 1082
- Semmelweis University
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Budapest, 헝가리, H-1032
- Fovarosi Onkormanyzat Szent Margit Korhaz, Okologia
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Budapest, 헝가리, H-1097
- Szent Laszlo Korhaz
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Budapest, 헝가리, H-1134
- Kozponti Honvedkorhaz I. Belgyogyaszat
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Debrecen, 헝가리, H-4012
- Debreceni Egyetem Onkologiai Tanzek
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Gydr, 헝가리, h-9024
- Petz Aladar County Hospital
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed adenocarcinoma of the colon or rectum
- Metastatic or recurrent disease that is not amenable to potentially curative treatment
- Progressive or recurrent disease during or after 1, and only 1, regimen of fluorouracil with or without leucovorin calcium or during or within 6 months after adjuvant chemotherapy with fluorouracil and leucovorin calcium
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Karnofsky 50-100%
Life expectancy:
- Not specified
Hematopoietic:
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- SGOT/SGPT no greater than 2 times ULN (no greater than 5 times ULN if liver metastases present)
- Alkaline phosphatase no greater than 2 times ULN (no greater than 5 times ULN if liver metastases present)
Renal:
- Creatinine no greater than 1.5 times ULN
Cardiovascular:
- No unstable angina
- No New York Heart Association class III or IV congestive heart failure
- No serious cardiac arrhythmia
- No history of cardiac toxicity from fluorouracil/leucovorin calcium
- No myocardial infarction within past 6 months
Pulmonary:
- No interstitial pneumonia or extensive and symptomatic fibrosis of the lung
Other:
- No uncontrolled predisposing colonic or small bowel disorder
- No prior chronic enteropathy, chronic diarrhea, or unresolved bowel obstruction/subobstruction
- No diabetes
- No active infection
- No known current peripheral neuropathy
- No concurrent active cancer except curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix
- No intolerance of appropriate antiemetics
- No history of anaphylaxis or potential intolerance to atropine sulfate or loperamide
- Not pregnant or nursing
- Negative pregnancy test
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- See Disease Characteristics
- At least 3 weeks since prior chemotherapy
- No prior irinotecan or oxaliplatin
- No other prior chemotherapy agents except fluorouracil with or without leucovorin calcium as first-line therapy for metastatic disease or in the adjuvant setting
Endocrine therapy:
- Not specified
Radiotherapy:
- Prior radiotherapy to non-target lesions allowed
- No prior radiotherapy to target lesions unless disease progression is documented within the radiation port
- At least 3 weeks since prior radiotherapy
Surgery:
- At least 4 weeks since prior major surgical procedure and recovered
- Prior surgery for primary tumor or metastasis allowed
Other:
- At least 30 days since prior investigational drug
- No concurrent investigational agents
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 마스킹: 없음(오픈 라벨)
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
수사관
- 연구 의자: Daniel G. Haller, MD, Abramson Cancer Center of the University of Pennsylvania
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2000년 12월 1일
연구 완료 (실제)
2008년 10월 1일
연구 등록 날짜
최초 제출
2001년 3월 3일
QC 기준을 충족하는 최초 제출
2003년 1월 26일
처음 게시됨 (추정)
2003년 1월 27일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2013년 12월 19일
QC 기준을 충족하는 마지막 업데이트 제출
2013년 12월 18일
마지막으로 확인됨
2002년 10월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .