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Neoadjuvant IRESSA As Single Agent PreopTherapy for NSCLC With Molecular Correlates

This study has been terminated.
(Early Stopping Rule: Would not meet interim analysis goal to proceed with enrollment)
Sponsor:
Collaborators:
AstraZeneca
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier:
NCT00104728
First received: March 3, 2005
Last updated: October 1, 2012
Last verified: September 2012
Results First Received: October 1, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Lung Cancer
Intervention: Drug: ZD1839

  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
No text entered.

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
Neoadjuvant ZD1839 Preoperative Therapy

The ZD1839 250-mg tablet will be taken once a day, every day about the same time. It can be taken with or without food.

At the time of surgery, investigators will collect tissue from the participant's tumor once it has been removed. This tissue will be used to study the effect of ZD1839 on tumor growth.

ZD1839 :


Participant Flow:   Overall Study
    Neoadjuvant ZD1839 Preoperative Therapy  
STARTED     42 [1]
COMPLETED     23  
NOT COMPLETED     19  
screen failures                 19  
[1] 42 consented on study



  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
Neoadjuvant ZD1839 Preoperative Therapy

The ZD1839 250-mg tablet will be taken once a day, every day about the same time. It can be taken with or without food.

At the time of surgery, investigators will collect tissue from the participant's tumor once it has been removed. This tissue will be used to study the effect of ZD1839 on tumor growth.

ZD1839 :


Baseline Measures
    Neoadjuvant ZD1839 Preoperative Therapy  
Number of Participants  
[units: participants]
  42  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     18  
>=65 years     24  
Gender  
[units: participants]
 
Female     22  
Male     20  
Region of Enrollment  
[units: participants]
 
United States     42  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Overall Response Rate (ORR)   [ Time Frame: 3 years ]

2.  Secondary:   Frequency of Toxicity Related to Study Treatment   [ Time Frame: 3 years ]


  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
Pilot study. At the time of interim analysis, the second early stopping rule was invoked for lack of activity (not enough responses to continue). Study closed to accrual 5/9/08.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Eric Haura
Organization: H. Lee Moffitt Cancer Center and Research Institute
phone: 813-745-6826
e-mail: eric.haura@moffitt.org


No publications provided


Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT00104728     History of Changes
Other Study ID Numbers: MCC-13922, IRUSIRES0256
Study First Received: March 3, 2005
Results First Received: October 1, 2012
Last Updated: October 1, 2012
Health Authority: United States: Food and Drug Administration