Cetuximab, Bevacizumab & 5FU/Leucovorin vs. Oxaliplatin, Bevacizumab & 5FU/Leucovorin in Metastatic Colorectal Cancer
Metastatic Colorectal Cancer
About this trial
This is an interventional treatment trial for Metastatic Colorectal Cancer
Eligibility Criteria
INCLUSION CRITERIA: 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 EXCLUSION CRITERIA: 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 Current or recent use of a thrombolytic agent within last 30 days. Use for clearance of central line catheter is permitted. Evidence of bleeding diathesis (disorder) or clinically significant coagulopathy (Note that deep venous thrombosis is not regarded as a reason for exclusion from this trial) Hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies History of arterial thromboembolic events within 6 months Urine protein:creatinine ratio greater than 1.0 at screening Pregnant or lactating woman Known to be HIV positive or receiving combination anti-retroviral therapy Unable to comply with study requirements
Sites / Locations
- Brimingham Hematology and Oncology
- Hematology Oncology Associates
- Northern AZ Hematology & Oncology Assoc
- Business Office - ACRC
- Cancer Care Associates of Fresno Medical Group, Inc (aka California Cancer Care)
- Monterey Bay Oncology
- Rocky Mountain Cancer Center-Midtown
- Greeley Medical Clinic Oncology Hematology, PC
- Connecticut Oncology & Hematology, LLP
- Integrated Community Oncology Network (ICON) / fka:Florida Oncology Associates
- Melbourne Internal Medicine Associates
- Florida Cancer Institute
- Ocala Oncology Center
- Cancer Centers of Florida, P.A.
- Medical Oncology Associates of Augusta PC
- Spalding Oncology Services
- Hematology Oncology Associates of IL
- Cancer Care & Hematology Specialists of Chicagoland
- Fort Wayne Medical Oncology Hematology, Inc
- Central Indiana Cancer Centers
- Hope Center
- Iowa Blood and Cancer Care
- Kansas City Cancer Centers-Southwest
- Cancer Center of Kansas
- Louisiana Hematology Oncology Associates
- Auerbach Hematology Oncology Associated
- Center for Cancer & Blood Disorders
- Maryland Oncology Hematology, P.A.
- Osteopathic Medical Oncology and Hematology
- Kalamazoo Hematology & Oncology
- Hematology Oncology Associates of Ohio & Michigan
- Minnesota Oncology Hematology, PA
- Missouri Cancer Associates
- Comprehensive Cancer Centers of Nevada
- Nevada Cancer Centers
- Hematology-Oncology Associates of NNJ, PA
- New York Oncology Hematology, PC
- North Shore Hematology
- Memorial Sloan-Kettering Cancer Center
- Raleigh Hematology Oncology Associates
- Northwestern Carolina Ocology Hemato
- Greater Dayton Cancer Center
- Willamette Valley Cancer Center
- Medical Oncology Associates
- Cancer Center Associates of Carolina, PA / fka Carolina Cancer Center
- Cancer Centers of the Carolinas
- C. Michael Jones, MD
- Texas Cancer Center-Abilene (Shouth)
- Texas Cancer Center
- Texas Oncology Cancer Center
- Mamie McFaddin Ward Cancer Center
- Texas Oncology, PA - Bedford
- Texas Cancer Center at Medical City
- Texas Oncology, PA
- The Texas Cancer Center
- Texas Oncology, PA
- Texas Cancer Center-Denton
- El Paso Cancer Treatment Ctr
- Texas Oncology, PA
- San Antonio Tumor & Blood Clinic
- Texas Oncology, PA
- Lake Vista Cancer Center
- Longview Cancer Center
- South Texas Cancer Center-McAllen
- Texas Cancer Center of Mesquite
- Allison Cancer Center
- West Texas Cancer Center
- Paris Regional Cancer Center
- HOAST - Medical Dr.
- Texas Cancer Center-Sherman
- Texas Oncology Cancer Center-Sugar Land
- Tyler Cancer Center
- Waco Cancer Care and Research Center
- Texas Oncology, P.A.
- Texas Oncology, PA
- Utah Cancer Specialists
- Virginia Oncology Associates
- Puget Sound Cancer Center-Edmonds
- Puget Sound Cancer Center Seattle
- Cancer Care Northwest-South
- Northwest Cancer Specialists-Vancouver
- Yakima Valley mem Hosp/North Star Lodge
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Bev-FOLFOX
FOLF-CB
(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): 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