Spots Global Cancer Trial Database for Regorafenib+FOLFIRI Versus Placebo+FOLFIRI as 2nd Line Tx in Metastatic Colorectal Cancer
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Trial Identification
Brief Title: Regorafenib+FOLFIRI Versus Placebo+FOLFIRI as 2nd Line Tx in Metastatic Colorectal Cancer
Official Title: 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
Study ID: NCT01298570
Conditions
Study Description
Brief Summary: This randomized (2:1), multi-center, placebo-controlled, phase II efficacy study is designed to compare PFS between regorafenib + FOLFIRI chemotherapy (ARM A) versus placebo + FOLFIRI (ARM B) in patients with mCRC previously treated with a FOLFOX regimen.
Detailed Description: 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 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Rocky Mountain Cancer Centers, Denver, Colorado, United States
Mount Sinai Medical Center-Miami, Miami, Florida, United States
Moffitt Cancer Center, Tampa, Florida, United States
Emory University, Atlanta, Georgia, United States
Georgia Cancer Specialists, Atlanta, Georgia, United States
Indiana University Simon Cancer Center, Indianapolis, Indiana, United States
University of Louisville James Brown Cancer Center, Louisville, Kentucky, United States
North Shore Long Island Jewish Health System, Manhasset, New York, United States
New York University Langone Medical Center, New York, New York, United States
Seby B. Jones Cancer Center, Boone, North Carolina, United States
University of North Carolina, Chapel Hill, North Carolina, United States
Carolinas HealthCare System, Charlotte, North Carolina, United States
Southeast Medical Oncology Center, Goldsboro, North Carolina, United States
The Moses Cone Regional Cancer Center, Greensboro, North Carolina, United States
Leo W. Jenkins Cancer Center at ECU Medical School, Greenville, North Carolina, United States
First Health of the Carolinas, Moore Regional Hospital, Pinehurst, North Carolina, United States
Rex Cancer Center at Rex Hospital, Raleigh, North Carolina, United States
Wake Forest University Comprehensive Cancer Center, Winston-Salem, North Carolina, United States
University of Cincinnati, Cincinnati, Ohio, United States
Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
University of Virginia, Charlottesville, Virginia, United States
Portsmouth Naval Medical Center, Portsmouth, Virginia, United States
Multicare Regional Cancer Center, Tacoma, Washington, United States
Ireland Cooperative Clinical Research Group, Dublin, , Ireland
Contact Details
Name: Hanna Sanoff, MD
Affiliation: UNC Lineberger Comprehensive Cancer Center
Role: PRINCIPAL_INVESTIGATOR
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