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

This study has been completed.

Sponsor:

Collaborator:

OSI Pharmaceuticals

Information provided by (Responsible Party):

Weill Medical College of Cornell University

ClinicalTrials.gov Identifier:

NCT00385996

First received: October 9, 2006

Last updated: December 13, 2012

Last verified: December 2012

History of Changes

Results First Received: October 12, 2012

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Carcinoma, Non-small Cell Lung
Intervention:	Drug: Tarceva (Erlotinib)

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The recruitment period was from 10/13/06 to 10/8/08. Patients were recruited from the Weill Cornell Medical College Thoracic Surgery outpatient office.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Erlotinib	Erlotinib 150 mg po daily.

Participant Flow: Overall Study

	Erlotinib
STARTED	22
COMPLETED	22
NOT COMPLETED	0

Baseline Characteristics

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Reporting Groups

	Description
Erlotinib	Erlotinib 150 mg po daily

Baseline Measures

	Erlotinib
Number of Participants [units: participants]	22
Age [units: years] Median ( Full Range )	71 ( 56 to 82 )
Gender [units: participants]
Female	11
Male	11
Region of Enrollment [units: participants]
United States	22

Outcome Measures

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1. Primary:

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®. ]

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2. Primary:

Safety of Tarceva in the Neoadjuvant Setting [ Time Frame: From the onset of the AE until 30 days after the last study drug dose, until recovery is noted, or until the Investigator determines the patient's condition is stable. ]

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3. Secondary:

Time-to-progression and Disease-free Survival. [ Time Frame: Every 3 months for the first 6 months, then yearly for 2 years. ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: Yes

4. Secondary:

Safety [ Time Frame: Day 1 of treatment to 2 years. ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: Yes

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Nasser Altorki, MD
Organization: Weill Cornell Medical College
phone: 212-746-5156
e-mail: nkaltork@med.cornell.edu

No publications provided

Responsible Party:	Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:	NCT00385996 History of Changes
Other Study ID Numbers:	OSI TAR 728
Study First Received:	October 9, 2006
Results First Received:	October 12, 2012
Last Updated:	December 13, 2012
Health Authority:	United States: Institutional Review Board

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