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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
6 mg/kg, 60-90 minute IV infusion every 2 weeks
85 mg/m2, 2-hour IV infusion every 2 weeks
125 mg/m2, 1-hour IV infusion every 2 weeks
NEA Baptist Clinic
Jonesboro, Arkansas, United States
Florida Cancer Specialists
Fort Myers, Florida, United States
Overall Response Rate (ORR)
The Percentage of Patients Who Experience an Objective Benefit From Treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time frame: 18 months
R0 Resection Rate
To determine the rate of complete (R0) resection for patients treated with this regimen.
Time frame: 18 months
Progression-free Survival (PFS)
The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Time frame: 18 months
To Determine the Acute Toxicity Produced by This Regimen.
The analyses of safety will be based on the frequency of adverse events and their severity for patients who received at least one dose of study treatment.
Time frame: 18 months
Overall Survival (OS)
The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death
Time frame: 18 months
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200 mg/m2, 2-hour IV infusion every 2 weeks
3200 mg/m2 IV, 48-hour continuous infusion every two weeks
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
...and 5 more locations