Comparison of Three Chemotherapy Regimens in Treating Patients With Metastatic Colorectal Cancer
NCT ID: NCT00008281
Last Updated: 2014-01-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
INTERVENTIONAL
2000-10-31
Brief Summary
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PURPOSE: Phase III trial to compare the effectiveness of three chemotherapy regimens in treating patients who have metastatic colorectal cancer.
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Detailed Description
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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 (1 vs 2 or more), and LDH value (up to 1.5 times upper limit of normal (ULN) vs greater than 1.5 times ULN). Patients are randomized to one of three treatment arms. Arm I: Patients receive leucovorin calcium IV over 2 hours followed by fluorouracil IV continuously over 22 hours on days 1 and 2. Arm II: Patients receive oxaliplatin IV over 2 hours on day 1. Arm III: Patients receive oxaliplatin IV concurrently with leucovorin calcium IV over 2 hours followed by fluorouracil IV continuously over 22 hours on day 1. Leucovorin calcium and fluorouracil are administered alone on day 2 on the same schedule as on day 1. Treatment repeats every 2 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients are followed for 30 days, every 2 weeks for up to 3 months, and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 786 patients (262 per arm) will be accrued for this study within 12 months.
Conditions
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Study Design
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TREATMENT
Interventions
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FOLFOX regimen
fluorouracil
leucovorin calcium
oxaliplatin
Eligibility Criteria
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Inclusion Criteria
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 50-100% Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) AST and ALT 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 3 times ULN if liver metastases present) Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: No uncontrolled high blood pressure No unstable angina, symptomatic congestive heart failure, or serious cardiac arrhythmia No New York Heart Association class III or IV heart disease No history of cardiac toxicities with prior fluorouracil and leucovorin calcium No myocardial infarction within the past 6 months Pulmonary: No interstitial pneumonia or extensive and symptomatic fibrosis of the lung Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 6 months after study No known dihydropyrimidine dehydrogenase deficiency No allergy to platinum-containing drugs No history of intolerance to study anti-emetics (e.g., 5-HT3 antagonists) No known peripheral neuropathy (absence of deep tendon reflexes as sole deficiency allowed) No uncontrolled diabetes No active infection No other active malignancy originating from primary site other than colon or rectum
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics One and only 1 prior chemotherapy regimen for metastatic disease consisting of first-line irinotecan, fluorouracil, and leucovorin calcium (Saltz regimen) Prior adjuvant fluorouracil with leucovorin calcium allowed At least 3 weeks since prior chemotherapy for metastatic disease and recovered No prior adjuvant irinotecan No prior oxaliplatin Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to study lesions unless evidence of progressive disease within the radiotherapy port At least 3 weeks since prior radiotherapy Surgery: See Disease Characteristics At least 4 weeks since prior major surgery and recovered Prior surgical resection of primary tumor or metastases allowed Other: At least 30 days since prior investigational drugs No other concurrent investigational agents No other concurrent anti-cancer therapy No concurrent participation in other investigational trials
18 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Principal Investigators
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Mace L. Rothenberg, MD, FACP
Role: STUDY_CHAIR
Vanderbilt-Ingram Cancer Center
Locations
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Comprehensive Cancer Institute of Huntsville
Huntsville, Alabama, United States
Oncology Center at Providence Park
Mobile, Alabama, United States
Arizona Clinical Research Center
Tucson, Arizona, United States
Arkansas Oncology Associates, P.A.
Little Rock, Arkansas, United States
Offices of Richard Shapiro, Benjamin Stafford, and Sharon J. Yee
Arcadia, California, United States
California Cancer Care, Inc.
Greenbrae, California, United States
Medical Oncology Internal Medicine
Los Angeles, California, United States
Bay Area Tumor Institute
Oakland, California, United States
Medical Oncology Care Associates
Orange, California, United States
P.M.K. Medical Group, Inc.
Oxnard, California, United States
Cancer and Blood Institute of the Desert
Rancho Mirage, California, United States
Kaiser Permanente-Southern California Permanente Medical Group
San Diego, California, United States
Kaiser Permanente Medical Center - Vallejo
Vallejo, California, United States
Kaiser Permanente - Denver
Denver, Colorado, United States
Rocky Mountain Cancer Center
Denver, Colorado, United States
Northwestern Connecticut Oncology-Hematology Associates
Torrington, Connecticut, United States
Lombardi Cancer Center
Washington D.C., District of Columbia, United States
Comprehensive Cancer Care Specialists of Boca Raton
Boca Raton, Florida, United States
Center for Hematology-Oncology
Boca Raton, Florida, United States
Florida Cancer Specialists
Fort Myers, Florida, United States
University of Florida Health Science Center
Gainesville, Florida, United States
Memorial Regional Hospital Comprehensive Cancer Center
Hollywood, Florida, United States
Florida Community Cancer Center
Hudson, Florida, United States
North Florida Hematology & Oncology Associates
Jacksonville, Florida, United States
Hematology/Oncology Associates
Jacksonville, Florida, United States
Lakeland Regional Medical Center
Lakeland, Florida, United States
Mount Sinai Comprehensive Cancer Center
Miami, Florida, United States
Oncology-Hematology Group of South Florida
Miami, Florida, United States
Ocala Oncology Center
Ocala, Florida, United States
Office of Thomas A. Marsland
Orange Park, Florida, United States
Florida Hospital Cancer Institute
Orlando, Florida, United States
Office of Barry S. Berman
Orlando, Florida, United States
Memorial Hospital West
Pembroke Pines, Florida, United States
Hematology-Oncology Associates, PA
Pensacola, Florida, United States
Hematology/Oncology Associates
Port Saint Lucie, Florida, United States
Oncology & Hematology Associates of West Broward
Tamarac, Florida, United States
Office of Ron D. Schiff
Tampa, Florida, United States
Hematology and Oncology Consultants
Titusville, Florida, United States
Dreyer Medical Clinic
Aurora, Illinois, United States
Northwestern Medical Faculty Foundation
Chicago, Illinois, United States
Hematology Oncology Associates of Illinois-Highland Park
Highland Park, Illinois, United States
Lutheran General Cancer Care Center
Park Ridge, Illinois, United States
Oncology and Hematology Associates
Greenfield, Indiana, United States
Cancer Care Center
New Albany, Indiana, United States
Oncology Associates of Cedar Rapids
Cedar Rapids, Iowa, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Cancer Center of Kansas - Wichita
Wichita, Kansas, United States
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, United States
James Graham Brown Cancer Center
Louisville, Kentucky, United States
Baton Rouge General Medical Center
Baton Rouge, Louisiana, United States
Louisiana Oncology Associates
Lafayette, Louisiana, United States
Physicians Office
Metairie, Louisiana, United States
Louisiana State University School of Medicine
New Orleans, Louisiana, United States
Maine Center for Cancer Medicine and Blood Disorders
Scarborough, Maine, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Parker Hughes Cancer Center
Roseville, Minnesota, United States
Park Nicollet Clinic
Saint Louis Park, Minnesota, United States
Columbia Comprehensive Cancer Care Clinic
Columbia, Missouri, United States
Missouri Cancer Associates
Columbia, Missouri, United States
Midwest Oncology Consortium
Kansas City, Missouri, United States
Missouri Cancer Care, P.C.
Saint Charles, Missouri, United States
Missouri Baptist Cancer Center
St Louis, Missouri, United States
St. John's Mercy Medical Center
St Louis, Missouri, United States
Cooper Hospital/University Medical Center
Voorhees Township, New Jersey, United States
Veterans Affairs Medical Center - Albany
Albany, New York, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
North Shore Hematology/Oncology Associates, P.C.
East Setauket, New York, United States
Capitol District Hematology Oncology Associates, P.C.
Latham, New York, United States
St. Vincents Comprehensive Cancer Center
New York, New York, United States
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York, New York, United States
Interlakes Oncology/Hematology PC
Rochester, New York, United States
State University of New York Health Sciences Center - Stony Brook
Stony Brook, New York, United States
Albert Einstein Comprehensive Cancer Center
The Bronx, New York, United States
New York Medical College
Valhalla, New York, United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, United States
Regional Hematology Oncology Associates
Durham, North Carolina, United States
Raleigh Hematology/Oncology Associates - Wake Practice
Raleigh, North Carolina, United States
Piedmont Hematology-Oncology Associates-Triad
Winston-Salem, North Carolina, United States
Hematology Oncology Consultants Inc
Columbus, Ohio, United States
Dayton Oncology/Hematology P.A.
Dayton, Ohio, United States
Naz Medical Center
Midwest City, Oklahoma, United States
Cancer Care Associates
Tulsa, Oklahoma, United States
Willamette Valley Cancer Center
Eugene, Oregon, United States
Abington Memorial Hospital
Abington, Pennsylvania, United States
Oncology/Hematology Associates - Beaver
Beaver, Pennsylvania, United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, United States
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States
Pennsylvania Oncology Hematology Associates
Philadelphia, Pennsylvania, United States
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States
Cancer Centers of the Carolinas
Greenville, South Carolina, United States
Erlanger Health Systems
Chattanooga, Tennessee, United States
Baptist Regional Cancer Center - Knoxville
Knoxville, Tennessee, United States
West Clinic, P.C.
Memphis, Tennessee, United States
Memphis Cancer Center
Memphis, Tennessee, United States
St. Thomas Medical Center
Nashville, Tennessee, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Lone Star Oncology
Austin, Texas, United States
Texas Oncology P.A.
Dallas, Texas, United States
Center for Oncology Research and Treatment, Medical City Hospital
Dallas, Texas, United States
Simmons Cancer Center - Dallas
Dallas, Texas, United States
Texas Cancer Center Southwest
Dallas, Texas, United States
Texas Oncology PA (TOPA) at Baylor-Sammons
Dallas, Texas, United States
Texas Oncology, P.A.
Fort Worth, Texas, United States
Texas Oncology, P.A.
Garland, Texas, United States
South Texas Regional Cancer Centers - McAllen
McAllen, Texas, United States
Texas Oncology - Mesquite
Mesqutie, Texas, United States
Baptist Health System Cancer Program
San Antonio, Texas, United States
San Antonio Tumor and Blood Clinic
San Antonio, Texas, United States
Tyler Cancer Center
Tyler, Texas, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States
Hematology-Oncology Associates of Frederiksburg, Inc.
Fredericksburg, Virginia, United States
Virginia Oncology Associates - Newport News
Newport News, Virginia, United States
Hematology & Oncology Associates of Virginia
Richmond, Virginia, United States
Virginia Mason Medical Center
Seattle, Washington, United States
Swedish Medical Center
Seattle, Washington, United States
Cancer Care Northwest
Spokane, Washington, United States
Northwest Cancer Specialists
Vancouver, Washington, United States
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States
Advanced Health Care
Milwaukee, Wisconsin, United States
UW Cancer Center Wausau Hospital
Wausau, Wisconsin, United States
Ivinson Memorial Hospital
Laramie, Wyoming, United States
Tom Baker Cancer Center - Calgary
Calgary, Alberta, Canada
University of Alberta
Edmonton, Alberta, Canada
St. Boniface General Hospital
Winnipeg, Manitoba, Canada
Nova Scotia Cancer Centre
Halifax, Nova Scotia, Canada
Belleville General Hospital
Belleville, Ontario, Canada
Cancer Care Ontario-London Regional Cancer Centre
London, Ontario, Canada
Peterborough Oncology Clinic
Peterborough, Ontario, Canada
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, Canada
Mount Sinai Hospital - Toronto
Toronto, Ontario, Canada
Princess Margaret Hospital
Toronto, Ontario, Canada
Notre Dame Hospital
Montreal, Quebec, Canada
Centre Hospitalier Regional de Rimouski
Rimouski, Quebec, Canada
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, Canada
Countries
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Other Identifiers
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SANOFI-EFC4584
Identifier Type: -
Identifier Source: secondary_id
BRCC-00036
Identifier Type: -
Identifier Source: secondary_id
CDR0000068394
Identifier Type: -
Identifier Source: org_study_id
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