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

Part of paid clinical trials in New York, New York.

Sponsor
Weill Medical College of Cornell University
Study ID
NCT00385996
Phase
PHASE2
Status
Completed

Conditions

  • Carcinoma, Non-small Cell Lung

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Tarceva (Erlotinib) — DRUG
    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.

Study Details

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.

Key Dates

First listed
Oct 11, 2006
Start date
Oct 31, 2006
Status verified
Dec 2018
Primary completion
Nov 30, 2008
Completion
Aug 31, 2011

Study Design

Enrollment
22 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Erlotinib
    Erlotinib 150mg/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.

Primary Outcome Measure

Response Rate Defined as the Percentage of Subjects Achieving at Least 50% Tumor Volume Reduction. [ Time Frame: High resolution CT scans for response assessment will be obtained after 3 weeks of treatment with Tarceva®. ]

Locations (1)

FacilityCityStateZIPSite coordinators
Weill Medical College of Cornell UniversityNew YorkNew York10021-

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By research site
Weill Medical College of Cornell University· New York, NY

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