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
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
No text entered.

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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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

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®. ]

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. ]

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 reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

4.  Secondary:   Safety   [ Time Frame: Day 1 of treatment to 2 years. ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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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  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.


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