Cetuximab, Bevacizumab & 5FU/Leucovorin vs. Oxaliplatin, Bevacizumab & 5FU/Leucovorin in Metastatic Colorectal Cancer
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
1 other identifier
interventional
247
1 country
82
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Sep 2005
Typical duration for phase_3
82 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2005
CompletedFirst Submitted
Initial submission to the registry
November 9, 2005
CompletedFirst Posted
Study publicly available on registry
November 11, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedResults Posted
Study results publicly available
March 14, 2011
CompletedFebruary 15, 2019
September 1, 2018
1.7 years
November 9, 2005
February 15, 2011
September 27, 2018
Conditions
Outcome Measures
Primary Outcomes (2)
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)
12 months
Progression-free Survival (PFS) Rate at 1 Year.
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).
12 months
Secondary Outcomes (2)
Overall Survival (OS)
up to 4 years
Objective Response Rate
12 months
Study Arms (2)
Bev-FOLFOX
EXPERIMENTAL(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
EXPERIMENTAL(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
Interventions
400 mg/m2, IV bolus followed by: 1200 mg/m2/day via 24-hour continuous infusion, for 2 consecutive days (total 5-FU infusion dose = 2400 mg/m2 over the 48 hour period)
400 mg/m2 over 2 hours (Cycle 1 Day 1 only) All subsequent doses (Day 8, 15, 22 of Cycle 1 and Days 1, 8, 15, 22 other cycles)250 mg/m2 over 1 hour
Eligibility Criteria
You may qualify if:
- Histologically or cytologically confirmed colorectal cancer with metastatic disease
- Measurable disease
- Previously irradiated lesions will be considered evaluable, if they progressed since radiation
- Has disease other than limited to surgically resectable liver-only or lung-only metastatic disease
- Not received prior chemo and/or biotherapy for metastatic disease
- Not received oxaliplatin, bevacizumab, or cetuximab in the adjuvant setting
- May have received 5-FU, leucovorin, and/or irinotecan in the adjuvant setting, however must have remained free of disease recurrence (including free of abnormal CEA level) for 1- year or more
- Is \>18 years of age
- ECOG performance status 0 or 1
- Normal organ \& marrow function
- Use of an acceptable method of birth control
- Not pregnant or breast feeding
- Paraffin tissue block(s) or 12 (minimum) unstained slides available, for assessment of potential predictive markers related to the EGFR, VEGF, DNA repair, and fluoropyrimidine catabolism pathways. If no block is available, slides (typically 7 to 10 um sections, air dried on uncharged slides) may be sent
- Signed a Patient Informed Consent Form
- Signed a Patient Authorization Form (HIPAA) Form
You may not qualify if:
- Had prior chemotherapy for metastatic colorectal cancer
- Received any prior treatment with oxaliplatin, bevacizumab, or cetuximab in the adjuvant treatment of their colorectal cancer
- Currently receiving any other investigational anticancer agents or has participated in an experimental drug study within the past 4 weeks
- History of primary CNS tumors, seizures not well-controlled with standard medical therapy, or stroke
- Sustained hypertension, as characterized by persistent blood pressures greater than 150/100 despite medical management
- New York Heart Association (NYHA) Grade II or greater congestive heart failure or has had angioplasty or placement of coronary stents within the past 6 months
- Clinically significant peripheral vascular disease
- History of serious allergic reactions attributed to compounds of similar chemical or biologic composition to bevacizumab, cetuximab, oxaliplatin, fluorouracil, leucovorin, or other agents used in the study
- Received prior cetuximab or other EGFR-directed therapy, or history of prior anti-cancer murine or chimeric monoclonal antibody therapy; prior humanized and human monoclonal antibody therapy is also excluded.
- Received prior treatment with bevacizumab or other agents specifically targeting VEGF or VEGF receptors
- Uncontrolled intercurrent illness including, not limited to, ongoing or active infection requiring parenteral antibiotics, symptomatic congestive heart failure, uncontrolled hypertension, clinically significant cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements in the opinion of the Investigator/Treating Physician
- Serious or non-healing active wound ulcer, or active bone fracture
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 1 of protocol treatment
- Minor surgical procedures such as fine needle aspirations or core biopsies within 7 days prior to Day 1
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 1
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- US Oncology Researchlead
- Bristol-Myers Squibbcollaborator
- Memorial Sloan Kettering Cancer Centercollaborator
- Prologue Research Internationalcollaborator
Study Sites (82)
Brimingham Hematology and Oncology
Birmingham, Alabama, 35235, United States
Hematology Oncology Associates
Phoenix, Arizona, 85012, United States
Northern AZ Hematology & Oncology Assoc
Sedona, Arizona, 86336, United States
Business Office - ACRC
Tucson, Arizona, 85715, United States
Cancer Care Associates of Fresno Medical Group, Inc (aka California Cancer Care)
Fresno, California, 93720, United States
Monterey Bay Oncology
Monterey, California, 93940, United States
Rocky Mountain Cancer Center-Midtown
Denver, Colorado, 80218, United States
Greeley Medical Clinic Oncology Hematology, PC
Greeley, Colorado, 80538, United States
Connecticut Oncology & Hematology, LLP
Torrington, Connecticut, 06790, United States
Integrated Community Oncology Network (ICON) / fka:Florida Oncology Associates
Jacksonville, Florida, 32204, United States
Melbourne Internal Medicine Associates
Melbourne, Florida, 32901, United States
Florida Cancer Institute
New Port Richey, Florida, 34655, United States
Ocala Oncology Center
Ocala, Florida, 34474, United States
Cancer Centers of Florida, P.A.
Ocoee, Florida, 34761, United States
Medical Oncology Associates of Augusta PC
Augusta, Georgia, 30901, United States
Spalding Oncology Services
Griffin, Georgia, 30224, United States
Hematology Oncology Associates of IL
Chicago, Illinois, 60611, United States
Cancer Care & Hematology Specialists of Chicagoland
Niles, Illinois, 60714, United States
Fort Wayne Medical Oncology Hematology, Inc
Fort Wayne, Indiana, 46815, United States
Central Indiana Cancer Centers
Indianapolis, Indiana, 46219, United States
Hope Center
Terre Haute, Indiana, 47802, United States
Iowa Blood and Cancer Care
Cedar Rapids, Iowa, 52402, United States
Kansas City Cancer Centers-Southwest
Overland Park, Kansas, 66210, United States
Cancer Center of Kansas
Wichita, Kansas, 67214, United States
Louisiana Hematology Oncology Associates
Baton Rouge, Louisiana, 70809, United States
Auerbach Hematology Oncology Associated
Baltimore, Maryland, 21237, United States
Center for Cancer & Blood Disorders
Bethesda, Maryland, 20817, United States
Maryland Oncology Hematology, P.A.
Columbia, Maryland, 21044, United States
Osteopathic Medical Oncology and Hematology
Clinton Township, Michigan, 48037, United States
Kalamazoo Hematology & Oncology
Kalamazoo, Michigan, 49048, United States
Hematology Oncology Associates of Ohio & Michigan
Lambertville, Michigan, 48144, United States
Minnesota Oncology Hematology, PA
Minneapolis, Minnesota, 55404, United States
Missouri Cancer Associates
Columbia, Missouri, 65201, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89109, United States
Nevada Cancer Centers
Las Vegas, Nevada, 89109, United States
Hematology-Oncology Associates of NNJ, PA
Morristown, New Jersey, 07960, United States
New York Oncology Hematology, PC
Albany, New York, 12208, United States
North Shore Hematology
East Setauket, New York, 11733, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, 10017, United States
Raleigh Hematology Oncology Associates
Cary, North Carolina, 27511, United States
Northwestern Carolina Ocology Hemato
Hickory, North Carolina, 28602, United States
Greater Dayton Cancer Center
Kettering, Ohio, 45409, United States
Willamette Valley Cancer Center
Eugene, Oregon, 97401, United States
Medical Oncology Associates
Kingston, Pennsylvania, 18704, United States
Cancer Center Associates of Carolina, PA / fka Carolina Cancer Center
Aiken, South Carolina, 29801, United States
Cancer Centers of the Carolinas
Greenville, South Carolina, 29605, United States
C. Michael Jones, MD
Germantown, Tennessee, 38138, United States
Texas Cancer Center-Abilene (Shouth)
Abilene, Texas, 79606, United States
Texas Cancer Center
Arlington, Texas, 76014, United States
Texas Oncology Cancer Center
Austin, Texas, 78731, United States
Mamie McFaddin Ward Cancer Center
Beaumont, Texas, 77702, United States
Texas Oncology, PA - Bedford
Bedford, Texas, 76022, United States
Texas Cancer Center at Medical City
Dallas, Texas, 75230, United States
Texas Oncology, PA
Dallas, Texas, 75231, United States
The Texas Cancer Center
Dallas, Texas, 75237, United States
Texas Oncology, PA
Dallas, Texas, 75246, United States
Texas Cancer Center-Denton
Denton, Texas, 76210, United States
El Paso Cancer Treatment Ctr
El Paso, Texas, 79915, United States
Texas Oncology, PA
Fort Worth, Texas, 76104, United States
San Antonio Tumor & Blood Clinic
Fredericksburg, Texas, 78624, United States
Texas Oncology, PA
Garland, Texas, 75042, United States
Lake Vista Cancer Center
Lewisville, Texas, 75067, United States
Longview Cancer Center
Longview, Texas, 75601, United States
South Texas Cancer Center-McAllen
McAllen, Texas, 78503, United States
Texas Cancer Center of Mesquite
Mesquite, Texas, 75150, United States
Allison Cancer Center
Midland, Texas, 79701, United States
West Texas Cancer Center
Odessa, Texas, 79761, United States
Paris Regional Cancer Center
Paris, Texas, 75460, United States
HOAST - Medical Dr.
San Antonio, Texas, 78229, United States
Texas Cancer Center-Sherman
Sherman, Texas, 75090, United States
Texas Oncology Cancer Center-Sugar Land
Sugar Land, Texas, 77479, United States
Tyler Cancer Center
Tyler, Texas, 75702, United States
Waco Cancer Care and Research Center
Waco, Texas, 76712, United States
Texas Oncology, P.A.
Webster, Texas, 77598, United States
Texas Oncology, PA
Webster, Texas, 77598, United States
Utah Cancer Specialists
Salt Lake City, Utah, 84106, United States
Virginia Oncology Associates
Norfolk, Virginia, 23502, United States
Puget Sound Cancer Center-Edmonds
Edmonds, Washington, 98026, United States
Puget Sound Cancer Center Seattle
Seattle, Washington, 98133, United States
Cancer Care Northwest-South
Spokane, Washington, 99202, United States
Northwest Cancer Specialists-Vancouver
Vancouver, Washington, 98684, United States
Yakima Valley mem Hosp/North Star Lodge
Yakima, Washington, 98902, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Allen L. Cohn
- Organization
- US Oncology
Study Officials
- PRINCIPAL INVESTIGATOR
Allen Cohn, MD
US Oncology Research
- PRINCIPAL INVESTIGATOR
Leonard Saltz, M.D.
Memorial Sloan Kettering Cancer Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 9, 2005
First Posted
November 11, 2005
Study Start
September 1, 2005
Primary Completion
June 1, 2007
Study Completion
June 1, 2009
Last Updated
February 15, 2019
Results First Posted
March 14, 2011
Record last verified: 2018-09