A Randomized Double-Blind Placebo-Controlled Phase II Trial of Sorafenib and Erlotinib or Erlotinib Alone in Previously Treated Advanced Non-Small Cell Lung Cancer
The rationale of this study is to combine two distinct kinase inhibitors to evaluate
synergistic inhibition of angiogenesis and epidermal growth factor receptor (EGFR)
signaling. Erlotinib is a oral tyrosine kinase inhibitor that targets EGFR. Sorafenib is a
oral tyrosine kinase inhibitor targeting vascular endothelial growth factor receptor
(VEGFR), platelet derived growth factor receptor beta, Raf-1, Flt-3, and C-kit. These agents
also do not exhibit overlapping adverse event profiles which provided additional support for
studying this combination therapy.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Overall Objective Response Rate (ORR)
18 months
No
David Spigel, M.D.
Study Chair
Sarah Cannon Research Institute
United States: Institutional Review Board
SCRI LUN 160
NCT00600015
February 2008
February 2009
Name | Location |
---|---|
Florida Cancer Specialists | Fort Myers, Florida 33901 |
Northeast Georgia Medical Center | Gainesville, Georgia 30501 |
South Carolina Oncology Associates, PA | Columbia, South Carolina 29210 |
Family Cancer Center | Collierville, Tennessee 38017 |
Virginia Cancer Institute | Richmond, Virginia 23230 |
Methodist Cancer Center | Omaha, Nebraska 68114 |
Center for Cancer and Blood Disorders | Bethesda, Maryland 20817 |
Cancer Care of Western North Carolina | Asheville, North Carolina 28801 |
Grand Rapids Clinical Oncology Program | Grand Rapids, Michigan 49503 |
Kansas City Cancer Centers | Lenexa, Kansas |
Tennessee Oncology, PLLC | Clarksville, Tennessee 37043 |
Coastal Bend Cancer Center | Corpus Christi, Texas 78404 |
Wellstar Cancer Research | Marietta, Georgia 30060 |
Oncology Hematology Care | Cincinnati, Ohio 45242 |
Chattanooga Oncology Hematology Associates | Chattanooga, Tennessee 37404 |
Mid Ohio Oncology/Hematology, Inc./ The Mark H. Zangmeister Center | Columbus, Ohio 43219 |