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Brief Title: FOLFOXIRI Plus Panitumumab Patients With Metastatic KRAS Wild-Type Colorectal Cancer With Liver Metastases Only
Official Title: 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
Study ID: NCT01226719
Brief Summary: In this Phase II study the investigators plan to determine the overall response rate (ORR) of the combination of FOLFOXIRI plus panitumumab as first-line treatment of patients with liver-only metastatic KRAS wild-type colorectal cancer.
Detailed Description: 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
NEA Baptist Clinic, Jonesboro, Arkansas, United States
Florida Cancer Specialists, Ft. Myers, Florida, United States
Florida Hospital Cancer Institute, Orlando, Florida, United States
Florida Cancer Specialists, St. Petersburg, Florida, United States
Northeast Georgia Medical Center, Gainesville, Georgia, United States
Hope Cancer Center, Terre Haute, Indiana, United States
Providence Medical Group, Terre Haute, Indiana, United States
Center for Cancer and Blood Disorders, Bethesda, Maryland, United States
Portsmouth Regional Hospital, Portsmouth, New Hampshire, United States
Hematology-Oncology Associates of Northern NJ, Morristown, New Jersey, United States
Oncology Hematology Care, Inc, Cincinnati, Ohio, United States
Chattanooga Oncology Hematology Associates, Chattanooga, Tennessee, United States
Family Cancer Center, Collierville, Tennessee, United States
Tennessee Oncology, PLLC, Nashville, Tennessee, United States
The Center for Cancer and Blood Disorders, Fort Worth, Texas, United States
Name: Johanna Bendell, MD
Affiliation: SCRI Development Innovations, LLC
Role: STUDY_CHAIR