Spots Global Cancer Trial Database for Fluorouracil and Leucovorin With or Without Oxaliplatin in Treating Patients With Recurrent Metastatic Colorectal Cancer
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Trial Identification
Brief Title: Fluorouracil and Leucovorin With or Without Oxaliplatin in Treating Patients With Recurrent Metastatic Colorectal Cancer
Official Title: 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
Study ID: NCT00016198
Conditions
Study Description
Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Randomized phase II trial to study the effectiveness of combining fluorouracil and leucovorin with or without oxaliplatin in treating patients who have recurrent metastatic colorectal cancer.
Detailed Description: 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Arizona Clinical Research Center, Tucson, Arizona, United States
Arkansas Cancer Clinic, P.A., Pine Bluff, Arkansas, United States
Citrus Valley Medical Center, Covina, California, United States
Cancer Center and Beckman Research Institute, City of Hope, Duarte, California, United States
California Cancer Care, Inc., Greenbrae, California, United States
Cedars-Sinai Medical Center, Los Angeles, California, United States
Kenmar Research Institute, Los Angeles, California, United States
Comprehensive Cancer Centers of the Desert, Palm Springs, California, United States
Kaiser Permanente-Southern California Permanente Medical Group, San Diego, California, United States
Kaiser Permanente Medical Center - Vallejo, Vallejo, California, United States
John Muir Medical Center, Walnut Creek, California, United States
Rocky Mountain Cancer Center, Denver, Colorado, United States
Northwestern Connecticut Oncology-Hematology Associates, Torrington, Connecticut, United States
Lombardi Cancer Center, Washington, District of Columbia, United States
Center for Hematology-Oncology, Boca Raton, Florida, United States
Halifax Medical Center, Daytona Beach, Florida, United States
Florida Cancer Specialists, Fort Myers, Florida, United States
Hematology/Oncology Associates, Jacksonville, Florida, United States
Lake Heart and Cancer Medical Center, Leesburg, Florida, United States
Oncology-Hematology Group of South Florida, Miami, Florida, United States
Florida Hospital Cancer Institute, Orlando, Florida, United States
Hematology/Oncology Associates, Port Saint Lucie, Florida, United States
Northwest Medical Specialists, P.C., Arlington Heights, Illinois, United States
Dreyer Medical Clinic, Aurora, Illinois, United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, Illinois, United States
Cancer Care Specialists of Central Illinois, S.C., Decatur, Illinois, United States
Hope Center, Terre Haute, Indiana, United States
Medical Oncology and Hematology Associates, Des Moines, Iowa, United States
Mercy Cancer Center, Mason City, Iowa, United States
Lucille Parker Markey Cancer 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
Cancer and Blood Institute, Metairie, Louisiana, United States
Saints Memorial Medical Center, Lowell, Massachusetts, United States
Saint Joseph Mercy Hospital, Ann Arbor, Michigan, United States
Medical Oncology Group, Gulfport, Mississippi, United States
Jackson Oncology Associates, PLLC, Jackson, Mississippi, United States
St. Joseph Oncology, Inc., Saint Joseph, Missouri, United States
Deaconess Billings Clinic, Billings, Montana, United States
Monmouth Medical Center, Long Branch, New Jersey, United States
Jersey Shore Cancer Center, Neptune, New Jersey, United States
Central Jersey Oncology Center, New Brunswick, New Jersey, United States
Hematology Associates of New Jersey, P.A., Ridgewood, New Jersey, United States
Monmouth Hematology-Oncology Associates, P.A., West Long Branch, New Jersey, United States
University of New Mexico Cancer Research & Treatment Center, Albuquerque, New Mexico, United States
Albert Einstein Comprehensive Cancer Center, Bronx, New York, United States
HemOnCare, P.C., Brooklyn, New York, United States
North Shore Hematology/Oncology Associates, P.C., East Setauket, New York, United States
Reddy Cancer Treatment Center, Malone, New York, United States
New York University Medical Center, New York, New York, United States
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
Interlakes Oncology/Hematology PC, Rochester, New York, United States
University of Rochester Medical Center, Rochester, New York, United States
South Shore Hematology Oncology Associates, P.C., Rockville Centre, New York, United States
New York Medical College, Valhalla, New York, United States
Mid-Ohio Oncology/Hematology, Inc., Columbus, Ohio, United States
Hematology Oncology Consultants Inc, Columbus, Ohio, United States
Lawrence M. Stallings Medical Practice, Wooster, Ohio, United States
Oklahoma Oncology Inc., Tulsa, Oklahoma, United States
Bend Memorial Clinic, Bend, Oregon, United States
Salem Hospital Regional Cancer Center, Salem, Oregon, United States
Oncology Hematology of Lehigh Valley, P.C., Bethlehem, Pennsylvania, United States
Pennsylvania Oncology Hematology Associates, Philadelphia, Pennsylvania, United States
Lifespan: The Miriam Hospital, Providence, Rhode Island, United States
Memorial Hospital Cancer Center - Chattanooga, Chattanooga, Tennessee, United States
Family Cancer Center, Collierville, Tennessee, United States
Baptist Regional Cancer Center, Knoxville, Tennessee, United States
West Cancer Clinic, Memphis, Tennessee, United States
Center for Oncology Research and Treatment, Medical City Hospital, Dallas, Texas, United States
Cancer Therapy and Research Center, San Antonio, Texas, United States
Scott and White Memorial Hospital, Temple, Texas, United States
Huntsman Cancer Institute, Salt Lake City, Utah, United States
Intermountain Hematology/Oncology Associates, Inc., Salt Lake City, Utah, United States
Seattle Cancer Care Alliance, Seattle, Washington, United States
Contact Details
Name: Richard A. Gams, MD
Affiliation: Prologue Research International
Role: STUDY_CHAIR
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