NCT01226719

FOLFOXIRI Plus Panitumumab Patients With Metastatic KRAS Wild-Type Colorectal Cancer With Liver Metastases Only

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: SCRI Development Innovations, LLC · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Panitumumab	6 mg/kg, 60-90 minute IV infusion every 2 weeks
DRUG	Oxaliplatin	85 mg/m2, 2-hour IV infusion every 2 weeks
DRUG	Irinotecan	125 mg/m2, 1-hour IV infusion every 2 weeks
DRUG	Leucovorin	200 mg/m2, 2-hour IV infusion every 2 weeks
DRUG	5-Fluorouracil	3200 mg/m2 IV, 48-hour continuous infusion every two weeks

Timeline

• Start date: 2010-12-01
• Primary completion: 2014-03-01
• Completion: 2014-03-01
• First posted: 2010-10-22
• Last updated: 2015-05-27
• Results posted: 2015-05-27

Locations

15 sites across 1 country: United States