Conditions: Colorectal Cancer
Keywords: liver-only metastatic KRAS wild-type colorectal cancer Panitumumab Oxaliplatin Irinotecan Leucovorin 5-Fluorouracil
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 15
Healthy volunteers: no

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.

Arms:
arm 1: All patients will receive the FOLFOXIRI/panitumumab regimen, with drugs administered in the following order:

* Panitumumab
* Oxaliplatin
* Irinotecan
* Leucovorin
* 5-Fluorouracil

Interventions: intervention 1: Panitumumab intervention 2: Oxaliplatin intervention 3: Irinotecan intervention 4: Leucovorin intervention 5: 5-Fluorouracil
Intervention descriptions: intervention 1: 6 mg/kg, 60-90 minute IV infusion every 2 weeks intervention 2: 85 mg/m2, 2-hour IV infusion every 2 weeks intervention 3: 125 mg/m2, 1-hour IV infusion every 2 weeks intervention 4: 200 mg/m2, 2-hour IV infusion every 2 weeks intervention 5: 3200 mg/m2 IV, 48-hour continuous infusion every two weeks

Protocol document: