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Evaluating Panitumumab (ABX-EGF) in Patients With Metastatic Colorectal Cancer

NCT00111761 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2013-12-12

Study results available
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Summary

The purpose of this study is to determine if panitumumab, in combination with irinotecan, leucovorin, and 5-fluorouracil (5-FU) is safe and efficacious in patients with metastatic colorectal cancer.

Conditions

Interventions

DRUG

Irinotecan

Part 1: 125 mg/m\^2 IV infusion once a week on weeks 1 through 4 of each 6-week treatment cycle. Part 2: 180 mg/m\^2 IV infusion every other week until disease progression or unable to tolerate.

BIOLOGICAL

Panitumumab

Intravenous (IV) infusions of panitumumab 2.5 mg/kg once a week delivered in 6-week cycles.

DRUG

5-Fluorouracil

Part 1: IV bolus 500 mg/m\^2 on weeks 1 through 4 of each 6-week cycle. Part 2: IV bolus 400 mg/m\^2 and infusional 2400-3000 mg/m\^2 over 46 hours once every other week until disease progression or unable to tolerate.

DRUG

Leucovorin

Part 1: IV bolus 20 mg/m\^2 on weeks 1 through 4 of each 6-week cycle. Part 2: 400 mg/m\^2 every other week until disease progression or unable to tolerate.

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-07-31
Primary Completion
2008-02-29
Completion
2008-10-31

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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 NCT00111761 on ClinicalTrials.gov