A Randomized, Multicenter, Phase II Study Of Bolus/Infusion 5-FU/LV (de Gramont Regimen) Versus Oxaliplatin And Bolus/Infusion 5-FU/LV (de Gramont Regimen) As Third-Line Treatment Of Patients With Metastatic Colorectal Carcinoma
OBJECTIVES: I. Compare the overall response rate and overall survival of patients with
recurrent metastatic colorectal adenocarcinoma treated with third-line therapy comprising
fluorouracil and leucovorin calcium with or without oxaliplatin. II. Compare the onset and
duration of complete and partial responses and duration of disease stabilization in patients
treated with these regimens. III. Compare the proportion of patients with stable disease and
proportion of patients with tumor-related symptomatic improvement treated with these
regimens. IV. Compare the time to disease progression and time to tumor-related symptomatic
worsening in patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two
treatment arms. Arm I: Patients receive leucovorin calcium IV over 2 hours and fluorouracil
IV over 2-4 minutes followed by fluorouracil IV continuously over 22 hours on days 1 and 2.
Arm II: Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours,
and fluorouracil IV over 2-4 minutes followed by fluorouracil IV continuously over 22 hours
on day 1. On day 2, patients receive leucovorin calcium and fluorouracil as in arm I.
Treatment in both arms repeats every 2 weeks for at least 1 year in the absence of disease
progression. Patients are followed at day 30 and then for approximately 6 months.
PROJECTED ACCRUAL: A total of 200 patients (100 per treatment arm) will be accrued for this
study.
Interventional
Primary Purpose: Treatment
Richard A. Gams, MD
Study Chair
Prologue Research International
United States: Federal Government
PROLOGUE-EFC4760
NCT00016198
May 2001
December 2010
Name | Location |
---|---|
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
Albert Einstein Comprehensive Cancer Center | Bronx, New York 10461 |
Robert H. Lurie Comprehensive Cancer Center, Northwestern University | Chicago, Illinois 60611 |
Lombardi Cancer Center | Washington, District of Columbia 20007 |
Huntsman Cancer Institute | Salt Lake City, Utah 84112 |
Halifax Medical Center | Daytona Beach, Florida 32114 |
James Graham Brown Cancer Center | Louisville, Kentucky 40202 |
New York Medical College | Valhalla, New York 10595 |
Cedars-Sinai Medical Center | Los Angeles, California 90048 |
Cancer Center and Beckman Research Institute, City of Hope | Duarte, California 91010-3000 |
University of Rochester Medical Center | Rochester, New York 14642 |
Kaiser Permanente Medical Center - Vallejo | Vallejo, California 94589 |
Lucille Parker Markey Cancer Center, University of Kentucky | Lexington, Kentucky 40536-0093 |
University of New Mexico Cancer Research & Treatment Center | Albuquerque, New Mexico 87131 |
Monmouth Medical Center | Long Branch, New Jersey 07740-6395 |
Florida Hospital Cancer Institute | Orlando, Florida 32804 |
Scott and White Memorial Hospital | Temple, Texas 76508 |
John Muir Medical Center | Walnut Creek, California 94598 |
Lifespan: The Miriam Hospital | Providence, Rhode Island 02906 |
California Cancer Care, Inc. | Greenbrae, California 94904-2007 |
Hematology Oncology Consultants Inc | Columbus, Ohio 43235 |
Comprehensive Cancer Centers of the Desert | Palm Springs, California 92262 |
Kaiser Permanente-Southern California Permanente Medical Group | San Diego, California 92120 |
Jersey Shore Cancer Center | Neptune, New Jersey 07753 |
Interlakes Oncology/Hematology PC | Rochester, New York 14623 |
Rocky Mountain Cancer Center | Denver, Colorado 80218 |
Oncology-Hematology Group of South Florida | Miami, Florida 33176 |
Cancer Care Specialists of Central Illinois, S.C. | Decatur, Illinois 62526 |
Oklahoma Oncology Inc. | Tulsa, Oklahoma 74104 |
Florida Cancer Specialists | Fort Myers, Florida 33901 |
Northwest Medical Specialists, P.C. | Arlington Heights, Illinois 60004 |
Cancer Therapy and Research Center | San Antonio, Texas 78229 |
Northwestern Connecticut Oncology-Hematology Associates | Torrington, Connecticut 06790 |
Medical Oncology and Hematology Associates | Des Moines, Iowa 50309 |
Mercy Cancer Center | Mason City, Iowa 50401 |
Saint Joseph Mercy Hospital | Ann Arbor, Michigan 48106 |
Salem Hospital Regional Cancer Center | Salem, Oregon 97309 |
HemOnCare, P.C. | Brooklyn, New York 11235 |
Mid-Ohio Oncology/Hematology, Inc. | Columbus, Ohio 43222 |
Seattle Cancer Care Alliance | Seattle, Washington 98109 |
Baton Rouge General Medical Center | Baton Rouge, Louisiana 70821-2511 |
Arizona Clinical Research Center | Tucson, Arizona 85712 |
Jackson Oncology Associates, PLLC | Jackson, Mississippi 39202 |
Pennsylvania Oncology Hematology Associates | Philadelphia, Pennsylvania 19107 |
Hematology/Oncology Associates | Port Saint Lucie, Florida 34952 |
Center for Oncology Research and Treatment, Medical City Hospital | Dallas, Texas 75230 |
Center for Hematology-Oncology | Boca Raton, Florida 33486 |
Intermountain Hematology/Oncology Associates, Inc. | Salt Lake City, Utah 84124 |
Memorial Hospital Cancer Center - Chattanooga | Chattanooga, Tennessee 37404 |
Hope Center | Terre Haute, Indiana 47809 |
Dreyer Medical Clinic | Aurora, Illinois 60506 |
North Shore Hematology/Oncology Associates, P.C. | East Setauket, New York 11733 |
Citrus Valley Medical Center | Covina, California 91722 |
Kenmar Research Institute | Los Angeles, California 90057 |
Lake Heart and Cancer Medical Center | Leesburg, Florida 34748 |
Bend Memorial Clinic | Bend, Oregon 97701 |
Arkansas Cancer Clinic, P.A. | Pine Bluff, Arkansas 71603 |
Cancer and Blood Institute | Metairie, Louisiana 70006 |
Saints Memorial Medical Center | Lowell, Massachusetts 01852 |
Medical Oncology Group | Gulfport, Mississippi 39501 |
St. Joseph Oncology, Inc. | Saint Joseph, Missouri 64506 |
Deaconess Billings Clinic | Billings, Montana 59107-5100 |
Central Jersey Oncology Center | New Brunswick, New Jersey 08901 |
Hematology Associates of New Jersey, P.A. | Ridgewood, New Jersey 07450 |
Monmouth Hematology-Oncology Associates, P.A. | West Long Branch, New Jersey 07764 |
Reddy Cancer Treatment Center | Malone, New York 12953 |
New York University Medical Center | New York, New York 10016 |
South Shore Hematology Oncology Associates, P.C. | Rockville Centre, New York 11570 |
Lawrence M. Stallings Medical Practice | Wooster, Ohio 44691 |
Oncology Hematology of Lehigh Valley, P.C. | Bethlehem, Pennsylvania 18015 |
Family Cancer Center | Collierville, Tennessee 38017 |
Baptist Regional Cancer Center | Knoxville, Tennessee 37920 |
West Cancer Clinic | Memphis, Tennessee 38120 |