Randomized PhIII Trial of Cetuximab, Bevacizumab & Biweekly Infusional 5FU/Leucovorin (FOLF-CB) vs. Oxaliplatin, Bevacizumab, & Biweekly Infusional 5FU/Leucovorin (Bev-FOLFOX) in First Line Treatment of Metastatic Colorectal Cancer
This is a Phase III, open label, nonblinded study. A total of 240 eligible patients will be
randomized on a 1:1 basis to either treatment Arm.
In this trial, we will compare the efficacy, safety, and tolerability of this novel
combination of biweekly infusional 5-FU/leucovorin plus cetuximab and bevacizumab (FOLF-CB)
to the current standard of care, biweekly infusional 5-FU/leucovorin plus oxaliplatin and
bevacizumab (Bev-FOLFOX). For practical purposes, this study will be a head to head
comparison of oxaliplatin versus cetuximab, since the other components of both regimens will
be the same.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-Free Survival (PFS)
From randomization to first progression or death, whichever comes first (event); or first new anti-cancer treatment if before or without progression / death (censoring); or last follow-up date otherwise (censoring). Kaplan-Meier median PFS time and PFS rate (at 12 months)
(no pre-determined maximum time)
No
Allen Cohn, MD
Principal Investigator
US Oncology Research
United States: Institutional Review Board
05-041
NCT00252564
September 2005
June 2009
Name | Location |
---|---|
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
Texas Oncology, P.A. | Dallas, Texas 75246 |
Virginia Oncology Associates | Newport News, Virginia 23606 |
Comprehensive Cancer Centers of Nevada | Las Vegas, Nevada 89109 |
Ocala Oncology Center | Ocala, Florida 34474 |
Cancer Centers of the Carolinas | Greenville, South Carolina 29605 |
Missouri Cancer Associates | Columbia, Missouri 65201 |
Tyler Cancer Center | Tyler, Texas 75702 |
Hope Center | Terre Haute, Indiana 47809 |
Willamette Valley Cancer Center | Eugene, Oregon 97401-8122 |
Iowa Blood and Cancer Care | Cedar Rapids, Iowa 52402 |
Monterey Bay Oncology | Monterey, California 93940 |
Cancer Centers of Florida, P.A. | Orlando, Florida |
Rocky Mountain Cancer Center-Midtown | Denver, Colorado 80218 |
Texas Oncology, PA | Dallas, Texas 75246-2006 |
Utah Cancer Specialists | Salt Lake City, Utah 84106 |
Northwest Cancer Specialists-Vancouver | Vancouver, Washington 98684 |
Medical Oncology Associates | Kingston, Pennsylvania 18704 |
Florida Cancer Institute | New Port Richey, Florida 34652 |
Central Indiana Cancer Centers | Indianapolis, Indiana 46227 |
Texas Cancer Center at Medical City | Dallas, Texas 75230 |
Allison Cancer Center | Midland, Texas 79701 |
West Texas Cancer Center | Odessa, Texas 79761 |
Center for Cancer & Blood Disorders | Bethesda, Maryland 20817 |
Hematology Oncology Associates | Phoenix, Arizona 85012 |
Greater Dayton Cancer Center | Kettering, Ohio 45409 |
Texas Cancer Center | Abilene, Texas 79606 |
Texas Oncology Cancer Center | Austin, Texas 78731 |
Mamie McFaddin Ward Cancer Center | Beaumont, Texas 77702 |
The Texas Cancer Center | Dallas, Texas 75237 |
San Antonio Tumor & Blood Clinic | Fredericksburg, Texas 78624 |
Lake Vista Cancer Center | Lewisville, Texas 75067 |
Longview Cancer Center | Longview, Texas 75601 |
Texas Cancer Center of Mesquite | Mesquite, Texas 75150 |
Nevada Cancer Centers | Las Vegas, Nevada 89109 |
Raleigh Hematology Oncology Associates | Cary, North Carolina 27511 |
Spalding Oncology Services | Griffin, Georgia 30224 |
Cancer Center of Kansas | Wichita, Kansas 67214 |
Minnesota Oncology Hematology, PA | Minneapolis, Minnesota 55404 |
New York Oncology Hematology, PC | Albany, New York 12208 |
Kalamazoo Hematology & Oncology | Kalamazoo, Michigan 49048 |
Maryland Oncology Hematology, P.A. | Columbia, Maryland 21044 |
Paris Regional Cancer Center | Paris, Texas 75460 |
Waco Cancer Care and Research Center | Waco, Texas 76712 |
Hematology Oncology Associates of Ohio & Michigan | Lambertville, Michigan 48144 |
Hematology Oncology Associates of IL | Chicago, Illinois 60611 |
Cancer Care & Hematology Specialists of Chicagoland | Niles, Illinois 60714 |
Northern AZ Hematology & Oncology Assoc | Sedona, Arizona 86336 |
Melbourne Internal Medicine Associates | Melbourne, Florida 32901 |
El Paso Cancer Treatment Ctr | El Paso, Texas 79915 |
South Texas Cancer Center-McAllen | McAllen, Texas 78503 |
Texas Cancer Center-Sherman | Sherman, Texas 75090 |
Texas Oncology Cancer Center-Sugar Land | Sugar Land, Texas 77479 |
Cancer Care Northwest-South | Spokane, Washington 99202 |
Yakima Valley Mem Hosp/North Star Lodge | Yakima, Washington 98902 |
Puget Sound Cancer Center-Edmonds | Edmonds, Washington 98026 |
Brimingham Hematology and Oncology | Birmingham, Alabama 35235 |
Business Office - ACRC | Tucson, Arizona 85715 |
Cancer Care Associates of Fresno Medical Group, Inc (aka California Cancer Care) | Fresno, California 93720 |
Greeley Medical Clinic Oncology Hematology, PC | Greeley, Colorado 80538 |
Connecticut Oncology & Hematology, LLP | Torrington, Connecticut 06790 |
Integrated Community Oncology Network (ICON) / fka:Florida Oncology Associates | Jacksonville, Florida 32204 |
Medical Oncology Associates of Augusta PC | Augusta, Georgia 30901 |
Fort Wayne Medical Oncology Hematology, Inc | Fort Wayne, Indiana 46815 |
Kansas City Cancer Centers-Southwest | Overland Park, Kansas 66210 |
Louisiana Hematology Oncology Associates | Baton Rouge, Louisiana 70809 |
Auerbach Hematology Oncology Associated | Baltimore, Maryland 21237 |
Osteopathic Medical Oncology and Hematology | Clinton Township, Michigan 48037 |
Hematology-Oncology Associates of NNJ, PA | Morristown, New Jersey 07960 |
North Shore Hematology | East Setauket, New York 11733 |
Northwestern Carolina Ocology Hemato | Hickory, North Carolina 28602 |
Cancer Center Associates of Carolina, PA / fka Carolina Cancer Center | Aiken, South Carolina 29801 |
C. Michael Jones, MD | Germantown, Tennessee 38138 |
Texas Cancer Center-Abilene (Shouth) | Abilene, Texas 79606 |
Texas Oncology, PA - Bedford | Bedford, Texas 76022 |
Texas Cancer Center-Denton | Denton, Texas 76210 |
HOAST - Medical Dr. | San Antonio, Texas 78229 |
Puget Sound Cancer Center Seattle | Seattle, Washington 98133 |