A Phase II Study of FOLFOXIRI Plus Panitumumab Followed by Evaluation for Resection, in Patients With Metastatic KRAS Wild-Type Colorectal Cancer With Liver Metastases Only
Further data has emerged showing a consistent lack of efficacy using EGFR inhibitor
panitumumab in combination with chemotherapy in the treatment of patients with KRAS mutant
colorectal cancer. For patients with liver-only metastatic colorectal cancer, improvement in
response rates with newer chemotherapy regimens has led to a larger percentage of patients
eligible for surgical resection. Treatment with FOLFOXIRI improves response rates when
compared to FOLFIRI. Similarly, the addition of an EGFR inhibitor improves the response
rate of FOLFIRI in patients with wild-type KRAS. In this trial, we will attempt to maximize
the response rate and the surgical resection rate by using FOLFOXIRI and panitumumab.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
overall response rate (ORR)
To determine the overall response rate (ORR) (ORR = complete + partial response rate) of the combination of FOLFOXIRI plus panitumumab as first-line treatment of patients with liver-only metastatic KRAS wild-type colorectal cancer.
18 months
No
Johanna Bendell, MD
Study Chair
Sarah Cannon Research Institute
United States: Food and Drug Administration
SCRI GI 134
NCT01226719
December 2010
December 2014
Name | Location |
---|---|
Florida Cancer Specialists | Fort Myers, Florida 33901 |
Northeast Georgia Medical Center | Gainesville, Georgia 30501 |
Family Cancer Center | Collierville, Tennessee 38017 |
Hematology-Oncology Associates of Northern NJ | Morristown, New Jersey 07962 |
The Center for Cancer and Blood Disorders | Fort Worth, Texas 76104 |
Center for Cancer and Blood Disorders | Bethesda, Maryland 20817 |
Portsmouth Regional Hospital | Portsmouth, New Hampshire 03802 |
Tennessee Oncology, PLLC | Clarksville, Tennessee 37043 |
Providence Medical Group | Terre Haute, Indiana 47802 |
National Capital Clinical Research Consortium | Bethesda, Maryland 20817 |
Chattanooga Oncology Hematology Associates | Chattanooga, Tennessee 37404 |
Oncology Hematology Care, Inc | Cincinnati, Ohio 45242 |
NEA Baptist Clinic | Jonesboro, Arkansas 72401 |