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WBRT & Erlotinib in Advanced NSCLC and Brain Metastases

NCT00554775 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2011-12-12

No results posted yet for this study

Summary

RATIONALE: Radiation therapy uses high energy x-rays to kill tumor cells. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Erlotinib may also make tumor cells more sensitive to radiation therapy. It is not yet known whether giving whole-brain radiation therapy together with erlotinib is more effective than whole-brain radiation therapy alone in treating patients with non-small cell lung cancer and brain metastases.

PURPOSE: This randomized phase II trial is studying whole-brain radiation therapy and erlotinib to see how well they work compared with whole-brain radiation therapy alone in treating patients with advanced non-small cell lung cancer and brain metastases.

Conditions

Interventions

DRUG

erlotinib hydrochloride

PO 100 mg daily during WBRT, increasing to 150mg daily after WBRT for up to 24 months

DRUG

placebo

WBRT plus matched placebo for the same schedule and duration as erlotinib hydrochloride

Sponsors & Collaborators

  • Cancer Research UK

    collaborator OTHER

  • Roche Pharma AG

    collaborator INDUSTRY

  • University College, London

    lead OTHER

Principal Investigators

  • Siow M. Lee, MD, PhD, FRCP · University College London Hospitals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2010-11-30
Completion
2010-11-30

Countries

  • United Kingdom

Study Locations

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Entities

Drugs
Diseases
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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 NCT00554775 on ClinicalTrials.gov