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

NCT01226719 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2015-05-27

Study results available
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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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Amgen

    collaborator INDUSTRY

  • SCRI Development Innovations, LLC

    lead OTHER

Principal Investigators

  • Johanna Bendell, MD · SCRI Development Innovations, LLC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2014-03-31
Completion
2014-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01226719 on ClinicalTrials.gov