Spots Global Cancer Trial Database for Comparison of Three Chemotherapy Regimens in Treating Patients With Metastatic Colorectal Cancer
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: Comparison of Three Chemotherapy Regimens in Treating Patients With Metastatic Colorectal Cancer
Official Title: 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
Study ID: NCT00008281
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. It is not yet known which regimen of chemotherapy is more effective for metastatic colorectal cancer. PURPOSE: Phase III trial to compare the effectiveness of three chemotherapy regimens in treating patients who have metastatic colorectal cancer.
Detailed Description: 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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, 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, St. 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 Baptist Cancer Center, Saint Louis, Missouri, United States
St. John's Mercy Medical Center, Saint Louis, Missouri, United States
Missouri Cancer Care, P.C., St. Charles, Missouri, United States
Cooper Hospital/University Medical Center, Voorhees, New Jersey, United States
Veterans Affairs Medical Center - Albany, Albany, New York, United States
Albert Einstein Comprehensive Cancer Center, Bronx, 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
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
Contact Details
Name: Mace L. Rothenberg, MD, FACP
Affiliation: Vanderbilt-Ingram Cancer Center
Role: STUDY_CHAIR
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
