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Dual Epidermal Growth Factor Receptor Inhibition With Erlotinib and Panitumumab With or Without Chemotherapy for Advanced Colorectal Cancer

NCT00940316 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2019-05-07

Study results available
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Summary

RATIONALE: Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as panitumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Panitumumab may also stop the growth of colorectal cancer by blocking blood flow to the tumor. Drugs used in chemotherapy, such as irinotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether erlotinib hydrochloride given together with panitumumab is more effective with or without irinotecan in treating patients with metastatic colorectal cancer.

PURPOSE: This randomized phase II trial is studying giving erlotinib hydrochloride together with panitumumab to see how well it works with or without irinotecan hydrochloride as second-line therapy in treating patients with metastatic colorectal cancer.

Conditions

Interventions

BIOLOGICAL

panitumumab

Given intravenously 6mg/kg every 2 weeks

DRUG

erlotinib hydrochloride

Given orally 150mg daily

DRUG

irinotecan hydrochloride

Given intravenously 120mg/m2 for 6/6 genotype and 60mg/m2 for 6/7 genotype

Sponsors & Collaborators

  • Genentech, Inc.

    collaborator INDUSTRY

  • OSI Pharmaceuticals

    collaborator INDUSTRY

  • Amgen

    collaborator INDUSTRY

  • Northwestern University

    lead OTHER

Principal Investigators

  • Al Benson, MD · Northwestern University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-18
Primary Completion
2015-01-31
Completion
2015-01-31

Countries

  • United States

Study Locations

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Entities

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 NCT00940316 on ClinicalTrials.gov