Irinotecan With or Without Oxaliplatin in Treating Patients With Metastatic Colorectal Cancer
- Conditions
- Colorectal Cancer
- Registration Number
- NCT00012389
- Lead Sponsor
- Sanofi
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (152)
University of Pennsylvania Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Northwestern Medical Faculty Foundation
🇺🇸Chicago, Illinois, United States
Hematology Oncology Consultants Inc
🇺🇸Columbus, Ohio, United States
Virginia Mason Medical Center
🇺🇸Seattle, Washington, United States
Oncology-Hematology Group of South Florida
🇺🇸Miami, Florida, United States
Porto Alegre Hospital
🇧🇷Porto Alegre, Rio Grande do Sul, Brazil
Irving Cancer Center
🇺🇸Laramie, Wyoming, United States
New York Medical College
🇺🇸Valhalla, New York, United States
Barbara Ann Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
Tennessee Oncology, P.L.L.C.
🇺🇸Nashville, Tennessee, United States
Vanderbilt-Ingram Cancer Center
🇺🇸Nashville, Tennessee, United States
Kenmar Research Institute
🇺🇸Los Angeles, California, United States
Colorado Permanente Medical Group, P.C.
🇺🇸Denver, Colorado, United States
P.M.K. Medical Group, Inc.
🇺🇸Oxnard, California, United States
Comprehensive Cancer Care Specialists of Boca Raton
🇺🇸Boca Raton, Florida, United States
Hematology and Oncology Consultants, P.A.
🇺🇸Orlando, Florida, United States
Rocky Mountain Cancer Center
🇺🇸Denver, Colorado, United States
Tower Hematology Oncology Medical Group
🇺🇸Los Angeles, California, United States
Southeast Florida Hematology-Oncology Group
🇺🇸Fort Lauderdale, Florida, United States
University of Colorado Cancer Center
🇺🇸Denver, Colorado, United States
Greater Baltimore Medical Center and Cancer Center
🇺🇸Baltimore, Maryland, United States
Oncology & Hematology Associates of West Broward
🇺🇸Tamarac, Florida, United States
Baton Rouge General Medical Center
🇺🇸Baton Rouge, Louisiana, United States
Center for Hematology-Oncology
🇺🇸Boca Raton, Florida, United States
Cancer and Blood Institute of the Desert
🇺🇸Rancho Mirage, California, United States
Kentuckiana Cancer Institute
🇺🇸Louisville, Kentucky, United States
Berkshire Hematology Oncology, P.C.
🇺🇸Pittsfield, Massachusetts, United States
Whittingham Cancer Center
🇺🇸Norwalk, Connecticut, United States
Lake Heart and Cancer Medical Center
🇺🇸Leesburg, Florida, United States
Citrus Valley Medical Center
🇺🇸Covina, California, United States
George Washington University Medical Center
🇺🇸Washington, District of Columbia, United States
California Cancer Care, Inc.
🇺🇸Greenbrae, California, United States
Dreyer Medical Clinic
🇺🇸Aurora, Illinois, United States
University of Florida Health Science Center - Jacksonville
🇺🇸Jacksonville, Florida, United States
University Community Hospital
🇺🇸Tampa, Florida, United States
Northwest Medical Specialists, P.C.
🇺🇸Arlington Heights, Illinois, United States
Hematology/Oncology Associates
🇺🇸Port Saint Lucie, Florida, United States
Centre Hospitalier Universitaire de Quebec
🇨🇦Quebec City, Quebec, Canada
Cite de la Sante de Laval
🇨🇦Laval, Quebec, Canada
Queens Medical Associates, PC
🇺🇸Fresh Meadows, New York, United States
Fovarosi Onkormanyzat Szent Margit Korhaz, Okologia
🇭🇺Budapest, Hungary
Zoom International Incoporated
🇨🇦St. Jerome Quebec, Canada
Memphis Cancer Center
🇺🇸Memphis, Tennessee, United States
Onkologicka Klinka A Onkologicka Lab
🇨🇿Prague, Czech Republic
Fakultni Nemocnice V Motole
🇨🇿Praha, Czech Republic
Jagiellonian University
🇵🇱Krakow (Cracow), Poland
UW Cancer Center Wausau Hospital
🇺🇸Wausau, Wisconsin, United States
L'Hotel Dieu de Levis
🇨🇦Levis, Quebec, Canada
Saskatoon Cancer Centre
🇨🇦Saskatoon, Saskatchewan, Canada
Maria S. Curie Memorial Institute
🇵🇱Gliwice, Poland
Toronto Sunnybrook Regional Cancer Centre
🇨🇦Toronto, Ontario, Canada
Derriford Hospital
🇬🇧Plymouth, England, United Kingdom
Maidstone Hospital
🇬🇧Maidstone, England, United Kingdom
Jewish General Hospital - Montreal
🇨🇦Montreal, Quebec, Canada
Guy's and St. Thomas' Hospitals NHS Trust
🇬🇧London, England, United Kingdom
Debreceni Egyetem Onkologiai Tanzek
🇭🇺Debrecen, Hungary
Petz Aladar County Hospital
🇭🇺Gydr, Hungary
Medical Oncology Care Associates
🇺🇸Orange, California, United States
Kaiser Permanente-Southern California Permanente Medical Group
🇺🇸San Diego, California, United States
John Wayne Cancer Institute
🇺🇸Santa Monica, California, United States
Hematology and Oncology Associates of Jacksonville
🇺🇸Jacksonville, Florida, United States
Albert B. Chandler Medical Center, University of Kentucky
🇺🇸Lexington, Kentucky, United States
Oncology Center at Providence Park
🇺🇸Mobile, Alabama, United States
Comprehensive Cancer Institute of Huntsville
🇺🇸Huntsville, Alabama, United States
Lakeland Regional Medical Center
🇺🇸Lakeland, Florida, United States
Hematology and Oncology Consultants
🇺🇸Titusville, Florida, United States
Stanley Scott Cancer Center
🇺🇸New Orleans, Louisiana, United States
Medical Center of Boston
🇺🇸Boston, Massachusetts, United States
Jackson Oncology Associates, PLLC
🇺🇸Jackson, Mississippi, United States
Missouri Cancer Care, P.C.
🇺🇸St. Charles, Missouri, United States
Siteman Cancer Center
🇺🇸Saint Louis, Missouri, United States
Great Falls Clinic
🇺🇸Great Falls, Montana, United States
Somerset Medical Center
🇺🇸Somerville, New Jersey, United States
Veterans Affairs Medical Center - Albany
🇺🇸Albany, New York, United States
Cooper Cancer Institute
🇺🇸Voorhees, New Jersey, United States
Lineberger Comprehensive Cancer Center, UNC
🇺🇸Chapel Hill, North Carolina, United States
Pennsylvania Oncology Hematology Associates
🇺🇸Philadelphia, Pennsylvania, United States
Kaiser Permanente - Portland
🇺🇸Portland, Oregon, United States
Lifespan: The Miriam Hospital
🇺🇸Providence, Rhode Island, United States
Physicians East - Quadrangle
🇺🇸Greenville, South Carolina, United States
Baptist Regional Cancer Center - Knoxville
🇺🇸Knoxville, Tennessee, United States
Cancer Centers of the Carolinas
🇺🇸Greenville, South Carolina, United States
Lone Star Oncology
🇺🇸Austin, Texas, United States
Baptist Health System Cancer Program
🇺🇸San Antonio, Texas, United States
Huntsman Cancer Institute
🇺🇸Salt Lake City, Utah, United States
Advanced Health Care
🇺🇸Milwaukee, Wisconsin, United States
Hospital Joao Alves Fiho
🇧🇷Aracaiu-SE, Brazil
Instituto de Oncologia de Soracaba
🇧🇷Sorocaba, Sao Paulo, Brazil
Tom Baker Cancer Center - Calgary
🇨🇦Calgary, Alberta, Canada
Oncologistas Associados
🇧🇷Rio de Janeiro, Brazil
Hospital Socor
🇧🇷Belo Horizonte-MG, Brazil
Hospital do Cancer A C Comargo
🇧🇷Sao Paulo, Brazil
Hospital Erastos Gaertner
🇧🇷Curitiba-PR, Brazil
University of Alberta
🇨🇦Edmonton, Alberta, Canada
Royal Victoria Hospital, Barrie
🇨🇦Barrie, Ontario, Canada
Northeastern Ontario Regional Cancer Centre, Sudbury
🇨🇦Sudbury, Ontario, Canada
Nova Scotia Cancer Centre
🇨🇦Halifax, Nova Scotia, Canada
Cancer Care Ontario-London Regional Cancer Centre
🇨🇦London, Ontario, Canada
Ottawa Regional Cancer Centre
🇨🇦Ottawa, Ontario, Canada
Mount Sinai Hospital - Toronto
🇨🇦Toronto, Ontario, Canada
Centre Hospitalier de L'Universitaire de Quebec, Pavillon CHUL
🇨🇦Sainte Foy, Quebec, Canada
Princess Margaret Hospital
🇨🇦Toronto, Ontario, Canada
L'Hopital Laval
🇨🇦Ste-Foy, Quebec, Canada
National Institute of Oncology
🇭🇺Budapest, Hungary
Weston Park Hospital
🇬🇧Sheffield, England, United Kingdom
Royal Marsden Hospital
🇬🇧Sutton, England, United Kingdom
Kaiser Permanente Medical Center - Vallejo
🇺🇸Vallejo, California, United States
Veterans Affairs Medical Center - Louisville
🇺🇸Louisville, Kentucky, United States
Florida Cancer Specialists
🇺🇸Fort Myers, Florida, United States
James Graham Brown Cancer Center
🇺🇸Louisville, Kentucky, United States
Cancer Care Center
🇺🇸New Albany, Indiana, United States
Queens Hospital Center
🇺🇸Jamaica, New York, United States
Norton Healthcare Pavilion
🇺🇸Louisville, Kentucky, United States
Veterans Affairs Medical Center - Kansas City
🇺🇸Kansas City, Missouri, United States
St. John's Mercy Medical Center
🇺🇸Saint Louis, Missouri, United States
Parker Hughes Cancer Center
🇺🇸Roseville, Minnesota, United States
Interlakes Oncology/Hematology PC
🇺🇸Rochester, New York, United States
Center for Oncology Research and Treatment, Medical City Hospital
🇺🇸Dallas, Texas, United States
Raleigh Hematology/Oncology Associates - Wake Practice
🇺🇸Raleigh, North Carolina, United States
Piedmont Hematology-Oncology Associates
🇺🇸Winston-Salem, North Carolina, United States
Hematology-Oncology Associates of Frederiksburg, Inc.
🇺🇸Fredericksburg, Virginia, United States
Cleveland Clinic Taussig Cancer Center
🇺🇸Cleveland, Ohio, United States
Abington Hematology Oncology Associates, Incorporated
🇺🇸Meadowbrook, Pennsylvania, United States
Bend Memorial Clinic
🇺🇸Bend, Oregon, United States
Pinnacle Health Hospitals
🇺🇸Harrisburg, Pennsylvania, United States
University of Pittsburgh Cancer Institute
🇺🇸Pittsburgh, Pennsylvania, United States
Instituto Nacional de Cancer
🇧🇷Rio de Janeiro, Brazil
Cancer Center at the University of Virginia
🇺🇸Charlottesville, Virginia, United States
Hopital Charles Lemoyne
🇨🇦Greenfield Park, Quebec, Canada
Centre of Clinical Oncology and Radiation Oncology
🇨🇿Ceske Budejovice, Czech Republic
Erlanger Health Systems
🇺🇸Chattanooga, Tennessee, United States
Kozponti Honvedkorhaz I. Belgyogyaszat
🇭🇺Budapest, Hungary
Charles University Hospital
🇨🇿Hradec Kralove, Czech Republic
Institute of Oncology
🇵🇱Lodz, Poland
Wielkopolskie Centrum Onkologii Oddzial Chemioterapii
🇵🇱Poznan, Poland
Aberdeen Royal Infirmary
🇬🇧Aberdeen, Scotland, United Kingdom
Semmelweis University
🇭🇺Budapest, Hungary
Szent Laszlo Korhaz
🇭🇺Budapest, Hungary
Maisonneuve-Rosemont Hospital
🇨🇦Montreal, Quebec, Canada
St. Luke's Cancer Center
🇬🇧Guildford, England, United Kingdom
Hopital Du Sacre-Coeur de Montreal
🇨🇦Montreal, Quebec, Canada
Western Montana Clinic
🇺🇸Missoula, Montana, United States
Louisiana Oncology Associates
🇺🇸Lafayette, Louisiana, United States
Christie Hospital N.H.S. Trust
🇬🇧Manchester, England, United Kingdom
St. Bartholomew's Hospital
🇬🇧London, England, United Kingdom
Arizona Clinical Research Center
🇺🇸Tucson, Arizona, United States
Shands Hospital and Clinics, University of Florida
🇺🇸Gainesville, Florida, United States
West Clinic
🇺🇸Memphis, Tennessee, United States
Doctors Hospital of Jefferson
🇺🇸Metairie, Louisiana, United States
North Idaho Cancer Center
🇺🇸Coeur d'Alene, Idaho, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States
Charing Cross Hospital
🇬🇧London, England, United Kingdom