Multi-Center, Randomized, Placebo-Controlled Phase II Study of Regorafenib in Combination With FOLFIRI Versus Placebo With FOLFIRI as Second-Line Therapy in Patients With Metastatic Colorectal Cancer
This randomized (2:1 ratio), multi-center, placebo-controlled, phase II efficacy study is
designed to compare progression-free survival (PFS) between regorafenib + FOLFIRI
(5-fluorouracil + leucovorin + irinotecan [ARM A] versus placebo + FOLFIRI [ARM B]) in
patients with KRAS or BRAF mutant metastatic colorectal carcinoma (mCRC) previously treated
with a FOLFOX (5-fluorouracil + leucovorin + oxaliplatin) regimen. Secondary objectives
include objective response (OR) rates, disease control (DC) rates, and overall survival
(OS). A pharmacokinetic (PK) evaluation of irinotecan will be conducted in a subset of
patients at selected sites. This trial also incorporates a number of exploratory analyses
designed to evaluate potential correlations between blood and tissue biomarkers and clinical
benefit.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Progression Free Survival (PFS)
To compare PFS between regorafenib + FOLFIRI chemotherapy (ARM A) versus placebo + FOLFIRI (ARM B) in patients failing one prior oxaliplatin-containing regimen for metastatic colorectal cancer
7 years
No
Bert O'Neil, MD
Principal Investigator
UNC Lineberger Comprehensive Cancer Center
United States: Food and Drug Administration
LCCC 1029
NCT01298570
February 2011
February 2021
Name | Location |
---|---|
Cancer Institute of New Jersey | New Brunswick, New Jersey 08901 |
Long Island Jewish Medical Center | New Hyde Park, New York 11040 |
Wake Forest University Comprehensive Cancer Center | Winston-Salem, North Carolina 27157-1096 |
Georgia Cancer Specialists | Decatur, Georgia 30033 |
Leo W. Jenkins Cancer Center at ECU Medical School | Greenville, North Carolina 27834 |
Rocky Mountain Cancer Centers | Thornton, Colorado 80260 |
Rex Cancer Center at Rex Hospital | Raleigh, North Carolina 27607 |
University of Virginia | Charlottesville, Virginia 22908 |
University of North Carolina | Chapel Hill, North Carolina 27599 |
Emory University | Atlanta, Georgia 30322 |
Carolinas HealthCare System | Charlotte, North Carolina |
Moffitt Cancer Center | Tampa, Florida 33612 |
University of Cincinnati | Cincinnati, Ohio 45267-0502 |
New York University Langone Medical Center | New York, New York 10016 |
Medical University of South Carolina (MUSC) | Charleston, South Carolina 29425 |
Marion L. Shepard Cancer Center | Washington, North Carolina |
NorthShore University HealthSystem | Evanston, Illinois |
Ohio State University Comprehensive Cancer Center | Columbus, Ohio |
Seby B. Jones Cancer Center | Boone, North Carolina 28607 |
New Bern Cancer Care, PA | New Bern, North Carolina 28562 |
Alamance Regional Cancer Center | Burlington, North Carolina 27215 |
Mount Sinai Medical Center-Miami | Miami, Florida 33140 |
University of Louisville James Brown Cancer Center | Louisville, Kentucky 40202 |
Southeast Medical Oncology Center | Goldsboro, North Carolina 27534 |
The Moses Cone Regional Cancer Center | Greensboro, North Carolina 27403 |
First Health of the Carolinas, Moore Regional Hospital | Pinehurst,, North Carolina 28374 |
Nash Health Care Systems | Rocky Mount, North Carolina 27804 |
Portsmouth Naval Medical Center | Portsmouth, Virginia 23708 |
Multicare Regional Cancer Center | Tacoma, Washington 98405 |
CBC/Baptist Hospital East | Louisville, Kentucky 40207 |