Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Phase II Trial to Correlate Radiographic Response Induced By Gefitinib With Mutations in the Protein-Tyrosine Kinase Domain of the EGF Receptor Gene

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00588445
First received: December 26, 2007
Last updated: December 17, 2015
Last verified: December 2015
Results First Received: December 17, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Lung Cancer
Non-small Cell Lung Cancer
Bronchioloalveolar Cancer
Intervention: Drug: Gefitinib

  Participant Flow
  Hide Participant Flow

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
Treatment

Gefitinib: Patients will receive gefitinib 250 mg po daily for at least 21 days preoperatively (depending on the timing of the surgery). Treatment with gefitinib will be stopped 2 days before the date of surgery.

Patients who have had at least a minor response to gefitinib therapy preoperatively (> 25% reduction in tumor measured bidimensionally) and / or have mutations in the protein-tyrosine kinase domain of the EGF receptor gene identified will continue on the study and will resume gefitinib treatment after at least 7 days from surgery providing adequate wound healing has occurred.

Patients who are determined to be candidates for adjuvant chemotherapy and/or radiation therapy by their treating physician may receive treatment with adjuvant chemotherapy and/or radiation therapy. The post-operative gefitinib will be started after completion of the chemotherapy and/or radiation therapy.


Participant Flow:   Overall Study
    Treatment  
STARTED     65  
COMPLETED     50  
NOT COMPLETED     15  
Protocol Violation                 1  
Withdrawal by Subject                 3  
Disease Progression                 1  
Not Treated                 10  



  Baseline Characteristics
  Hide Baseline Characteristics

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
Treatment

Gefitinib: Patients will receive gefitinib 250 mg po daily for at least 21 days preoperatively (depending on the timing of the surgery). Treatment with gefitinib will be stopped 2 days before the date of surgery.

Patients who have had at least a minor response to gefitinib therapy preoperatively (> 25% reduction in tumor measured bidimensionally) and / or have mutations in the protein-tyrosine kinase domain of the EGF receptor gene identified will continue on the study and will resume gefitinib treatment after at least 7 days from surgery providing adequate wound healing has occurred.

Patients who are determined to be candidates for adjuvant chemotherapy and/or radiation therapy by their treating physician may receive treatment with adjuvant chemotherapy and/or radiation therapy. The post-operative gefitinib will be started after completion of the chemotherapy and/or radiation therapy.


Baseline Measures
    Treatment  
Number of Participants  
[units: participants]
  65  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     33  
>=65 years     32  
Gender  
[units: participants]
 
Female     51  
Male     14  
Region of Enrollment  
[units: participants]
 
United States     65  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   The Radiographic Response to Gefitinib   [ Time Frame: 21 days ]

2.  Secondary:   Microarray Analysis to Identify Gene(s) or Gene Clusters That Exhibit Changes in Gene Expression; Time to Relapse and Overall Survival Data   [ Time Frame: 2 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
No text entered.


  More Information
  Hide More Information

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


Results Point of Contact:  
Name/Title: Dr. Charles Rudin
Organization: Memorial Sloan Kettering Cancer Center
phone: 646-888-4527
e-mail: rudinc@mskcc.org


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00588445     History of Changes
Other Study ID Numbers: 04-071
CA113653
Study First Received: December 26, 2007
Results First Received: December 17, 2015
Last Updated: December 17, 2015
Health Authority: United States: Institutional Review Board