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QOL-Stereotactic RadioSurgery, Temozolomide + Erlotinib-Rx of 1-3 Brain Metastases in NSCLC

NCT00385398 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2013-09-02

No results posted yet for this study

Summary

RATIONALE: Treatment with radiosurgery, temozolomide, and erlotinib may affect brain function (the ability to think, learn, remember, and judge) in patients with non-small cell lung cancer and brain metastases. A study that evaluates brain function may help doctors plan the best treatment.

PURPOSE: This phase II trial is studying the effect of radiosurgery, temozolomide, and erlotinib on brain function in patients with non-small cell lung cancer and brain metastases.

Conditions

Interventions

DRUG

erlotinib hydrochloride

Erlotinib will be administered orally on at a dose of 200 mg/day on Days 1-23 of each 28 day cycle.

DRUG

temozolomide

Temozolomide will be administered orally at a dose of 150 mg/m2 on Days 1-5 for Cycle 1 then increased to 200 mg/m2 for Cycle 2 forward.

RADIATION

stereotactic radiosurgery

Stereotactic radiosurgery will be performed prior to chemotherapy.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Schering-Plough

    collaborator INDUSTRY

  • Genentech, Inc.

    collaborator INDUSTRY

  • University of Medicine and Dentistry of New Jersey

    lead OTHER

Principal Investigators

  • Molly Gabel, MD · Rutgers Cancer Institute of New Jersey

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2008-12-31
Completion
2008-12-31

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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 NCT00385398 on ClinicalTrials.gov