Cetuximab, Bevacizumab & 5FU/Leucovorin vs. Oxaliplatin, Bevacizumab & 5FU/Leucovorin in Metastatic Colorectal Cancer
- Conditions
- Metastatic Colorectal Cancer
- Interventions
- Registration Number
- NCT00252564
- Lead Sponsor
- US Oncology Research
- Brief Summary
The purpose of this study is to compare the rates of Progression-Free Survival (PFS) at 12 months for patients treated with Bev-FOLFOX versus patients treated with FOLF-CB for first line treatment of metastatic colorectal cancer.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 247
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Bev-FOLFOX Bevacizumab (Bev-FOLFOX): Bevacizumab, followed by oxaliplatin and LV given simultaneously via "T" connector over 2 hours, followed by bolus 5-FU followed by infusional 5-FU. Bevacizumab --\> oxaliplatin and LV --\> bolus 5-FU --\> infusional 5-FU Dosing on Days 1 and 15 of each 28-day cycle Bev-FOLFOX Leucovorin (Bev-FOLFOX): Bevacizumab, followed by oxaliplatin and LV given simultaneously via "T" connector over 2 hours, followed by bolus 5-FU followed by infusional 5-FU. Bevacizumab --\> oxaliplatin and LV --\> bolus 5-FU --\> infusional 5-FU Dosing on Days 1 and 15 of each 28-day cycle Bev-FOLFOX Oxaliplatin (Bev-FOLFOX): Bevacizumab, followed by oxaliplatin and LV given simultaneously via "T" connector over 2 hours, followed by bolus 5-FU followed by infusional 5-FU. Bevacizumab --\> oxaliplatin and LV --\> bolus 5-FU --\> infusional 5-FU Dosing on Days 1 and 15 of each 28-day cycle Bev-FOLFOX Fluorouracil (Bev-FOLFOX): Bevacizumab, followed by oxaliplatin and LV given simultaneously via "T" connector over 2 hours, followed by bolus 5-FU followed by infusional 5-FU. Bevacizumab --\> oxaliplatin and LV --\> bolus 5-FU --\> infusional 5-FU Dosing on Days 1 and 15 of each 28-day cycle FOLF-CB Fluorouracil (FOLF-CB): Cetuximab administered over 2 hours (first dose only; administer all other doses over 1 hour) followed by bevacizumab over 30 minutes, followed by LV over 30 minutes, followed by bolus 5-FU followed by infusional 5-FU. Cetuximab --\> bevacizumab --\> LV --\> bolus 5-FU --\> infusional 5-FU FOLF-CB Bevacizumab (FOLF-CB): Cetuximab administered over 2 hours (first dose only; administer all other doses over 1 hour) followed by bevacizumab over 30 minutes, followed by LV over 30 minutes, followed by bolus 5-FU followed by infusional 5-FU. Cetuximab --\> bevacizumab --\> LV --\> bolus 5-FU --\> infusional 5-FU FOLF-CB Leucovorin (FOLF-CB): Cetuximab administered over 2 hours (first dose only; administer all other doses over 1 hour) followed by bevacizumab over 30 minutes, followed by LV over 30 minutes, followed by bolus 5-FU followed by infusional 5-FU. Cetuximab --\> bevacizumab --\> LV --\> bolus 5-FU --\> infusional 5-FU FOLF-CB Cetuximab (FOLF-CB): Cetuximab administered over 2 hours (first dose only; administer all other doses over 1 hour) followed by bevacizumab over 30 minutes, followed by LV over 30 minutes, followed by bolus 5-FU followed by infusional 5-FU. Cetuximab --\> bevacizumab --\> LV --\> bolus 5-FU --\> infusional 5-FU
- Primary Outcome Measures
Name Time Method Progression-Free Survival (PFS) 12 months 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)Progression-free Survival (PFS) Rate at 1 Year. 12 months 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).
- Secondary Outcome Measures
Name Time Method Overall Survival (OS) up to 4 years From randomization to death (event); or last follow-up date if alive (censoring).
Kaplan-Meier OS median time.Objective Response Rate 12 months Percentage of patients with tumor response (by RECIST criteria, including complete response, or CR, i.e. disappearance of all target lesions; and partial response, or PR, i.e. at least a 30% decrease in the sum of the longest diameters of target lesions taking as reference the baseline sum of the longest diameters) among all "per-protocol population" patients.
Trial Locations
- Locations (78)
Melbourne Internal Medicine Associates
🇺🇸Melbourne, Florida, United States
Maryland Oncology Hematology, P.A.
🇺🇸Columbia, Maryland, United States
Hematology Oncology Associates of Ohio & Michigan
🇺🇸Lambertville, Michigan, United States
New York Oncology Hematology, PC
🇺🇸Albany, New York, United States
Raleigh Hematology Oncology Associates
🇺🇸Cary, North Carolina, United States
Puget Sound Cancer Center-Edmonds
🇺🇸Edmonds, Washington, United States
Greater Dayton Cancer Center
🇺🇸Kettering, Ohio, United States
The Texas Cancer Center
🇺🇸Dallas, Texas, United States
Texas Cancer Center-Sherman
🇺🇸Sherman, Texas, United States
Hematology Oncology Associates of IL
🇺🇸Chicago, Illinois, United States
Spalding Oncology Services
🇺🇸Griffin, Georgia, United States
Cancer Care Associates of Fresno Medical Group, Inc (aka California Cancer Care)
🇺🇸Fresno, California, United States
Texas Cancer Center
🇺🇸Arlington, Texas, United States
Integrated Community Oncology Network (ICON) / fka:Florida Oncology Associates
🇺🇸Jacksonville, Florida, United States
Kansas City Cancer Centers-Southwest
🇺🇸Overland Park, Kansas, United States
Ocala Oncology Center
🇺🇸Ocala, Florida, United States
Hope Center
🇺🇸Terre Haute, Indiana, United States
Auerbach Hematology Oncology Associated
🇺🇸Baltimore, Maryland, United States
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States
Connecticut Oncology & Hematology, LLP
🇺🇸Torrington, Connecticut, United States
Cancer Care & Hematology Specialists of Chicagoland
🇺🇸Niles, Illinois, United States
Kalamazoo Hematology & Oncology
🇺🇸Kalamazoo, Michigan, United States
Cancer Center of Kansas
🇺🇸Wichita, Kansas, United States
North Shore Hematology
🇺🇸East Setauket, New York, United States
Virginia Oncology Associates
🇺🇸Norfolk, Virginia, United States
Puget Sound Cancer Center Seattle
🇺🇸Seattle, Washington, United States
Central Indiana Cancer Centers
🇺🇸Indianapolis, Indiana, United States
Minnesota Oncology Hematology, PA
🇺🇸Minneapolis, Minnesota, United States
Comprehensive Cancer Centers of Nevada
🇺🇸Las Vegas, Nevada, United States
Nevada Cancer Centers
🇺🇸Las Vegas, Nevada, United States
HOAST - Medical Dr.
🇺🇸San Antonio, Texas, United States
Hematology Oncology Associates
🇺🇸Phoenix, Arizona, United States
Utah Cancer Specialists
🇺🇸Salt Lake City, Utah, United States
Brimingham Hematology and Oncology
🇺🇸Birmingham, Alabama, United States
Rocky Mountain Cancer Center-Midtown
🇺🇸Denver, Colorado, United States
Willamette Valley Cancer Center
🇺🇸Eugene, Oregon, United States
Texas Cancer Center-Denton
🇺🇸Denton, Texas, United States
Tyler Cancer Center
🇺🇸Tyler, Texas, United States
Texas Cancer Center-Abilene (Shouth)
🇺🇸Abilene, Texas, United States
Longview Cancer Center
🇺🇸Longview, Texas, United States
Hematology-Oncology Associates of NNJ, PA
🇺🇸Morristown, New Jersey, United States
Northwestern Carolina Ocology Hemato
🇺🇸Hickory, North Carolina, United States
Cancer Centers of the Carolinas
🇺🇸Greenville, South Carolina, United States
Cancer Center Associates of Carolina, PA / fka Carolina Cancer Center
🇺🇸Aiken, South Carolina, United States
Texas Oncology Cancer Center
🇺🇸Austin, Texas, United States
Texas Oncology, P.A.
🇺🇸Webster, Texas, United States
West Texas Cancer Center
🇺🇸Odessa, Texas, United States
Mamie McFaddin Ward Cancer Center
🇺🇸Beaumont, Texas, United States
Texas Oncology, PA - Bedford
🇺🇸Bedford, Texas, United States
Texas Oncology, PA
🇺🇸Webster, Texas, United States
El Paso Cancer Treatment Ctr
🇺🇸El Paso, Texas, United States
Lake Vista Cancer Center
🇺🇸Lewisville, Texas, United States
San Antonio Tumor & Blood Clinic
🇺🇸Fredericksburg, Texas, United States
Allison Cancer Center
🇺🇸Midland, Texas, United States
South Texas Cancer Center-McAllen
🇺🇸McAllen, Texas, United States
Northern AZ Hematology & Oncology Assoc
🇺🇸Sedona, Arizona, United States
Florida Cancer Institute
🇺🇸New Port Richey, Florida, United States
Business Office - ACRC
🇺🇸Tucson, Arizona, United States
Monterey Bay Oncology
🇺🇸Monterey, California, United States
Medical Oncology Associates of Augusta PC
🇺🇸Augusta, Georgia, United States
Cancer Centers of Florida, P.A.
🇺🇸Ocoee, Florida, United States
Fort Wayne Medical Oncology Hematology, Inc
🇺🇸Fort Wayne, Indiana, United States
Greeley Medical Clinic Oncology Hematology, PC
🇺🇸Greeley, Colorado, United States
Iowa Blood and Cancer Care
🇺🇸Cedar Rapids, Iowa, United States
Center for Cancer & Blood Disorders
🇺🇸Bethesda, Maryland, United States
Louisiana Hematology Oncology Associates
🇺🇸Baton Rouge, Louisiana, United States
Missouri Cancer Associates
🇺🇸Columbia, Missouri, United States
Osteopathic Medical Oncology and Hematology
🇺🇸Clinton Township, Michigan, United States
Medical Oncology Associates
🇺🇸Kingston, Pennsylvania, United States
Texas Cancer Center at Medical City
🇺🇸Dallas, Texas, United States
C. Michael Jones, MD
🇺🇸Germantown, Tennessee, United States
Paris Regional Cancer Center
🇺🇸Paris, Texas, United States
Texas Cancer Center of Mesquite
🇺🇸Mesquite, Texas, United States
Texas Oncology Cancer Center-Sugar Land
🇺🇸Sugar Land, Texas, United States
Waco Cancer Care and Research Center
🇺🇸Waco, Texas, United States
Northwest Cancer Specialists-Vancouver
🇺🇸Vancouver, Washington, United States
Yakima Valley mem Hosp/North Star Lodge
🇺🇸Yakima, Washington, United States
Cancer Care Northwest-South
🇺🇸Spokane, Washington, United States