Spots Global Cancer Trial Database for Oxaliplatin and Bevacizumab (Avastin™) With Either Fluorouracil and Leucovorin or Capecitabine in Treating Patients With Advanced Colorectal Cancer
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Trial Identification
Brief Title: Oxaliplatin and Bevacizumab (Avastin™) With Either Fluorouracil and Leucovorin or Capecitabine in Treating Patients With Advanced Colorectal Cancer
Official Title: A Randomized, Prospective Study Comparing Three Regimens Of Eloxatin ™ Plus Fluoropyrimidine For Evaluation Of Safety And Tolerability In First Line Treatment Of Patients With Advanced Colorectal Cancer (Tree Study)
Study ID: NCT00062426
Conditions
Study Description
Brief Summary: RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, fluorouracil, leucovorin, and capecitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving them in different combinations may kill more tumor cells. Monoclonal antibodies, such as bevacizumab (Avastin™), can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them. It is not yet known which regimen works better in treating advanced colorectal cancer. PURPOSE: This randomized phase III trial is to see if oxaliplatin and bevacizumab work better when combined with either fluorouracil and leucovorin or capecitabine in treating patients who have metastatic or recurrent colorectal cancer.
Detailed Description: OBJECTIVES: * Compare the incidence of grade 3 and 4 toxic effects occurring within the first 12 weeks of treatment with 2 different schedules of oxaliplatin, bevacizumab (Avastin™), leucovorin calcium, and fluorouracil or with oxaliplatin, Avastin™, and capecitabine in patients with advanced colorectal cancer. * Compare the overall response rate, progression-free survival, and time to treatment failure in patients treated with these regimens. * Compare the composite toxicity of these regimens in these patients. OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to 1 of 3 treatment arms. * Arm I: Patients receive bevacizumab (Avastin™) IV over 30-90 minutes, oxaliplatin IV over 2 hours, and leucovorin calcium IV over 2 hours on day 1 and fluorouracil (5-FU) IV over 46 hours beginning on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. * Arm II: Patients receive Avastin™ IV over 30-90 minutes and oxaliplatin IV over 2 hours on days 1 and 15 and leucovorin calcium IV over 10 minutes and 5-FU IV over 3 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. * Arm III: Patients receive Avastin™ IV over 30-90 minutes and oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed at 1 month, every 3 months for at least 2 years, and then every 6 months thereafter. PROJECTED ACCRUAL: A total of 375 patients (125 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
University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham, Alabama, United States
Arizona Clinical Research Center, Tucson, Arizona, United States
California Cancer Care, Inc., Greenbrae, California, United States
Valley Tumor Medical Group, Lancaster, California, United States
Cancer and Blood Institute of the Desert, Rancho Mirage, California, United States
Rocky Mountain Cancer Centers - Midtown, Denver, Colorado, United States
Northwestern Connecticut Oncology-Hematology Associates, Torrington, Connecticut, United States
Lombardi Cancer Center at Georgetown University Medical Center, Washington, District of Columbia, United States
Lynn Regional Cancer Center West, Boca Raton, Florida, United States
Florida Cancer Specialists, Fort Myers, Florida, United States
Florida Oncology Associates, Jacksonville, Florida, United States
Hematology and Oncology Consultants, P.A., Orlando, Florida, United States
Hematology Oncology Associates of theTreasure Coast - Port St. Lucie, Port St. Lucie, Florida, United States
Palm Beach Cancer Institute, West Palm Beach, Florida, United States
Peachtree Hematology and Oncology Consultants, P.C., Atlanta, Georgia, United States
North Idaho Cancer Center, Coeur d'Alene, Idaho, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University, Chicago, Illinois, United States
Lutheran General Cancer Care Center, Park Ridge, Illinois, United States
West Suburban Center for Cancer Care, River Forest, Illinois, United States
Saint Anthony Medical Center, Rockford, Illinois, United States
CCOP - Northern Indiana CR Consortium, South Bend, Indiana, United States
Cedar Rapids Oncology Associates, Cedar Rapids, Iowa, United States
CCOP - Wichita, Wichita, Kansas, United States
Greater Baltimore Medical Center and Cancer Center, Baltimore, Maryland, United States
Jackson Oncology Associates, PLLC, Jackson, Mississippi, United States
Veterans Affairs Medical Center - Kansas City, Kansas City, Missouri, United States
Deaconess Billings Clinic Cancer Center, Billings, Montana, United States
Cooper Cancer Institute at Cooper University Hospital, Voorhees, New Jersey, United States
Advanced Oncology Associates, Armonk, New York, United States
North Shore Hematology/Oncology Associates, P.C., East Setauket, New York, United States
Arena Oncology Associates, Great Neck, New York, United States
St. Vincents Comprehensive Cancer Center, New York, New York, United States
New York University Medical Center, New York, New York, United States
New York Medical College, Valhalla, New York, United States
Duke Comprehensive Cancer Center, Durham, North Carolina, United States
Southeastern Medical Oncology Center, Goldsboro, North Carolina, United States
Physicians East - Quadrangle, Greenville, North Carolina, United States
Raleigh Hematology/Oncology Associates, P.A. - Wake Practice, Raleigh, North Carolina, United States
Hematology Oncology Consultants Inc, Columbus, Ohio, United States
Hematology/Oncology of Salem, Salem, Oregon, United States
Pennsylvania Oncology Hematology Associates, Philadelphia, Pennsylvania, United States
Hillman Cancer Center at University of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania, United States
Charleston Hematology-Oncology, P.A., Charleston, South Carolina, United States
McCleod Cancer and Blood Center, Johnson City, Tennessee, United States
Memphis Cancer Center, Memphis, Tennessee, United States
West Clinic, Memphis, Tennessee, United States
Sarah Cannon Cancer Center at Centennial Medical Center, Nashville, Tennessee, United States
Lone Star Oncology, Austin, Texas, United States
Medical City Dallas Hospital, Dallas, Texas, United States
South Texas Oncology and Hematology, San Antonio, Texas, United States
Center for Cancer Prevention and Care at Scott and White Clinic, Temple, Texas, United States
Medical Consultants, Milwaukee, Wisconsin, United States
Contact Details
Name: Richard A. Gams, MD
Affiliation: Prologue Research International
Role: STUDY_CHAIR
Name: Lauri Welles, MD
Affiliation: Sanofi-Synthelabo
Role:
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