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)
Brimingham Hematology and Oncology
🇺🇸Birmingham, Alabama, United States
Hematology Oncology Associates
🇺🇸Phoenix, Arizona, United States
Northern AZ Hematology & Oncology Assoc
🇺🇸Sedona, Arizona, United States
Business Office - ACRC
🇺🇸Tucson, Arizona, United States
Cancer Care Associates of Fresno Medical Group, Inc (aka California Cancer Care)
🇺🇸Fresno, California, United States
Monterey Bay Oncology
🇺🇸Monterey, California, United States
Rocky Mountain Cancer Center-Midtown
🇺🇸Denver, Colorado, United States
Greeley Medical Clinic Oncology Hematology, PC
🇺🇸Greeley, Colorado, United States
Connecticut Oncology & Hematology, LLP
🇺🇸Torrington, Connecticut, United States
Integrated Community Oncology Network (ICON) / fka:Florida Oncology Associates
🇺🇸Jacksonville, Florida, United States
Scroll for more (68 remaining)Brimingham Hematology and Oncology🇺🇸Birmingham, Alabama, United States