A Multicenter, Open-Label, Randomized, Three-Arm Study Of 5-Fluorouracil (5-FU) Plus Leucovorin (LV) Or Oxaliplatin Or A Combination Of (5-Fu) LV + Oxaliplatin As Second-Line Treatment Of Metastatic Colorectal Carcinoma
OBJECTIVES: I. Compare the overall survival of patients with metastatic colorectal carcinoma
treated with fluorouracil and leucovorin calcium with vs without oxaliplatin vs oxaliplatin
alone. II. Compare the response rate, time to tumor-related symptomatic worsening, time to
disease progression, onset and duration of complete and partial responses, and duration of
disease stabilization in patients treated with these regimens. III. Determine the safety
profile 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
(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.
Interventional
Primary Purpose: Treatment
Mace L. Rothenberg, MD, FACP
Study Chair
Vanderbilt-Ingram Cancer Center
United States: Federal Government
CDR0000068394
NCT00008281
October 2000
Name | Location |
---|---|
Roswell Park Cancer Institute | Buffalo, New York 14263 |
Albert Einstein Comprehensive Cancer Center | Bronx, New York 10461 |
Albert B. Chandler Medical Center, University of Kentucky | Lexington, Kentucky 40536-0084 |
Barbara Ann Karmanos Cancer Institute | Detroit, Michigan 48201 |
Cooper Hospital/University Medical Center | Camden, New Jersey 08103 |
State University of New York Health Sciences Center - Stony Brook | Stony Brook, New York 11790-7775 |
Lineberger Comprehensive Cancer Center, UNC | Chapel Hill, North Carolina 27599-7295 |
Abington Memorial Hospital | Abington, Pennsylvania 19001 |
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia | Philadelphia, Pennsylvania 19107 |
University of Pennsylvania Cancer Center | Philadelphia, Pennsylvania 19104 |
Simmons Cancer Center - Dallas | Dallas, Texas 75235-9154 |
University of Pittsburgh Cancer Institute | Pittsburgh, Pennsylvania 15213 |
Baptist Regional Cancer Center - Knoxville | Knoxville, Tennessee 37901 |
Vanderbilt-Ingram Cancer Center | Nashville, Tennessee 37232-6838 |
NYU School of Medicine's Kaplan Comprehensive Cancer Center | New York, New York 10016 |
Lombardi Cancer Center | Washington, District of Columbia 20007 |
Huntsman Cancer Institute | Salt Lake City, Utah 84112 |
University of Florida Health Science Center | Gainesville, Florida 32610-0296 |
Lutheran General Cancer Care Center | Park Ridge, Illinois 60068 |
James Graham Brown Cancer Center | Louisville, Kentucky 40202 |
Veterans Affairs Medical Center - Albany | Albany, New York 12208 |
New York Medical College | Valhalla, New York 10595 |
Virginia Mason Medical Center | Seattle, Washington 98111 |
University of Wisconsin Comprehensive Cancer Center | Madison, Wisconsin 53792 |
Texas Oncology, P.A. | Dallas, Texas 75246 |
University of Kansas Medical Center | Kansas City, Kansas 66160-7353 |
Kaiser Permanente Medical Center - Vallejo | Vallejo, California 94589 |
Virginia Oncology Associates - Newport News | Newport News, Virginia 23606 |
Comprehensive Cancer Institute of Huntsville | Huntsville, Alabama 35801 |
Florida Hospital Cancer Institute | Orlando, Florida 32804 |
Memorial Regional Hospital Comprehensive Cancer Center | Hollywood, Florida 33021 |
California Cancer Care, Inc. | Greenbrae, California 94904-2007 |
Hematology Oncology Consultants Inc | Columbus, Ohio 43235 |
Kaiser Permanente-Southern California Permanente Medical Group | San Diego, California 92120 |
Columbia Comprehensive Cancer Care Clinic | Columbia, Missouri 65201 |
Interlakes Oncology/Hematology PC | Rochester, New York 14623 |
Rocky Mountain Cancer Center | Denver, Colorado 80218 |
Oncology-Hematology Group of South Florida | Miami, Florida 33176 |
Louisiana State University School of Medicine | New Orleans, Louisiana 70112-2822 |
Texas Oncology PA (TOPA) at Baylor-Sammons | Dallas, Texas 75246 |
Ocala Oncology Center | Ocala, Florida 34474 |
Cancer Centers of the Carolinas | Greenville, South Carolina 29605 |
Mount Sinai Comprehensive Cancer Center | Miami Beach, Florida 33140 |
Oncology Center at Providence Park | Mobile, Alabama 36608 |
St. Vincents Comprehensive Cancer Center | New York, New York 10011 |
Florida Cancer Specialists | Fort Myers, Florida 33901 |
Louisiana Oncology Associates | Lafayette, Louisiana 70506 |
Lone Star Oncology | Austin, Texas 78759 |
Maine Center for Cancer Medicine and Blood Disorders | Scarborough, Maine 04074 |
Park Nicollet Clinic | St. Louis Park, Minnesota 55416 |
Northwestern Connecticut Oncology-Hematology Associates | Torrington, Connecticut 06790 |
Hematology Oncology Associates of Illinois-Highland Park | Highland Park, Illinois 60035 |
Cancer Center of Kansas - Wichita | Wichita, Kansas 67214 |
UW Cancer Center Wausau Hospital | Wausau, Wisconsin 54401 |
Missouri Cancer Associates | Columbia, Missouri 65201 |
Missouri Baptist Cancer Center | St. Louis, Missouri 63131 |
Kaiser Permanente - Denver | Denver, Colorado 80205 |
Cancer Care Center | New Albany, Indiana 47150 |
Cancer and Blood Institute of the Desert | Rancho Mirage, California 92270 |
Midwest Oncology Consortium | Kansas City, Missouri 64111 |
St. John's Mercy Medical Center | Saint Louis, Missouri 63141 |
Lakeland Regional Medical Center | Lakeland, Florida 33804 |
Baton Rouge General Medical Center | Baton Rouge, Louisiana 70821-2511 |
Arizona Clinical Research Center | Tucson, Arizona 85712 |
Pennsylvania Oncology Hematology Associates | Philadelphia, Pennsylvania 19107 |
Hematology & Oncology Associates of Virginia | Richmond, Virginia 23226 |
Texas Oncology P.A. | Dallas, Texas 75230-2503 |
West Clinic, P.C. | Memphis, Tennessee 38117 |
Comprehensive Cancer Care Specialists of Boca Raton | Boca Raton, Florida 33428 |
Hematology/Oncology Associates | Port Saint Lucie, Florida 34952 |
Raleigh Hematology/Oncology Associates - Wake Practice | Raleigh, North Carolina 27609 |
Tyler Cancer Center | Tyler, Texas 75702 |
Center for Oncology Research and Treatment, Medical City Hospital | Dallas, Texas 75230 |
Memphis Cancer Center | Memphis, Tennessee 38119 |
Office of Barry S. Berman | Orlando, Florida 32806 |
Cancer Care Northwest | Spokane, Washington 99202 |
Center for Hematology-Oncology | Boca Raton, Florida 33486 |
Hematology-Oncology Associates, PA | Pensacola, Florida 32501 |
Erlanger Health Systems | Chattanooga, Tennessee 37403 |
Arkansas Oncology Associates, P.A. | Little Rock, Arkansas 72207 |
Offices of Richard Shapiro, Benjamin Stafford, and Sharon J. Yee | Arcadia, California 91007-7678 |
Medical Oncology Internal Medicine | Los Angeles, California 90067 |
Bay Area Tumor Institute | Oakland, California 94609 |
Medical Oncology Care Associates | Orange, California 92668 |
P.M.K. Medical Group, Inc. | Oxnard, California 93030 |
Florida Community Cancer Center | Hudson, Florida 34667 |
North Florida Hematology & Oncology Associates | Jacksonville, Florida 32204 |
Office of Thomas A. Marsland | Orange Park, Florida 32073 |
Memorial Hospital West | Pembroke Pines, Florida 33028 |
Oncology & Hematology Associates of West Broward | Tamarac, Florida 33321 |
Office of Ron D. Schiff | Tampa, Florida 33613 |
Hematology and Oncology Consultants | Titusville, Florida 32796 |
Dreyer Medical Clinic | Aurora, Illinois 60506 |
Northwestern Medical Faculty Foundation | Chicago, Illinois 60611 |
Oncology and Hematology Associates | Greenfield, Indiana 46140 |
Oncology Associates of Cedar Rapids | Cedar Rapids, Iowa 52403 |
Physicians Office | Metairie, Louisiana 70006 |
Parker Hughes Cancer Center | Roseville, Minnesota 55113 |
Missouri Cancer Care, P.C. | St. Charles, Missouri 63301 |
North Shore Hematology/Oncology Associates, P.C. | East Setauket, New York 11733 |
Capitol District Hematology Oncology Associates, P.C. | Latham, New York 12110-0610 |
Regional Hematology Oncology Associates | Durham, North Carolina 27704 |
Piedmont Hematology-Oncology Associates-Triad | Winston-Salem, North Carolina 27103 |
Dayton Oncology/Hematology P.A. | Dayton, Ohio 45439 |
Naz Medical Center | Midwest City, Oklahoma 73310 |
Cancer Care Associates | Tulsa, Oklahoma 74136 |
Willamette Valley Cancer Center | Eugene, Oregon 97401-8122 |
Oncology/Hematology Associates - Beaver | Beaver, Pennsylvania 15009 |
St. Thomas Medical Center | Nashville, Tennessee 37205 |
Texas Cancer Center Southwest | Dallas, Texas 75235 |
South Texas Regional Cancer Centers - McAllen | McAllen, Texas 78503 |
Texas Oncology - Mesquite | Mesqutie, Texas 75150 |
Baptist Health System Cancer Program | San Antonio, Texas 78205 |
San Antonio Tumor and Blood Clinic | San Antonio, Texas 78217 |
Hematology-Oncology Associates of Frederiksburg, Inc. | Fredericksburg, Virginia 22401 |
Swedish Medical Center | Seattle, Washington 98122-4307 |
Northwest Cancer Specialists | Vancouver, Washington 98664 |
Advanced Health Care | Milwaukee, Wisconsin 53209 |
Ivinson Memorial Hospital | Laramie, Wyoming 82070 |