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Pilot Study of Preoperative Tarceva (Erlotinib) for Stages I/II Non-Small Cell Lung Cancer

NCT00385996 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2018-12-28

Study results available
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Summary

The main purpose of this study is to see if Tarceva® (erlotinib) is effective in shrinking tumors. A high resolution CT scan (CT scanner that can view 3 dimensional images of the tumor) will be used to measure the tumor before and after treatment with Tarceva®(erlotinib) . This type of CT scan will measure the tumor by volume and by standard measurement (length and width). Both methods will be compared to find out whether standard measurement or measurement by tumor volume is more accurate.

Conditions

  • Carcinoma, Non-small Cell Lung

Interventions

DRUG

Tarceva (Erlotinib)

Patients will receive daily erlotinib at 150 mg/day for 3 weeks followed by surgical resection at week 4 then daily Tarceva® at 150 mg/day for 2 years for those patients who had a response rate of at least 50% tumor volume reduction and/or have EGFR-positive tumor tissue determined by IHC and/or FISH.

Sponsors & Collaborators

  • OSI Pharmaceuticals

    collaborator INDUSTRY

  • Weill Medical College of Cornell University

    lead OTHER

Principal Investigators

  • Nasser K Altorki, MD · Weill Medical College of Cornell University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2008-11-30
Completion
2011-08-31

Countries

  • United States

Study Locations

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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 NCT00385996 on ClinicalTrials.gov