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Histological Characterization and Differentiation of Rash From Other Epidermal Growth Factor Receptor (EGFR) Inhibitors

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
Northwestern University
ClinicalTrials.gov Identifier:
NCT00709878
First received: July 1, 2008
Last updated: December 6, 2010
Last verified: December 2010
History of Changes
Results First Received: August 27, 2010  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Retrospective
Condition: Skin Rash
Intervention: Procedure: Skin Biopsy of Skin Rash Secondary to EGFRI Use

  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
A total of 8 samples per patient/inhibitor were collected, with a total of 32 patient specimens analyzed for this study.

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
Patients Treated With Lapatinib (L) Patients treated with lapatinib who developed skin toxicities and have been biopsied for skin rash.
Patients Treated With Cetuximab (C) Patients treated with cetuximab who developed skin toxicities and have been biopsied for skin rash.
Patients Treated With Panitumumab (P) Patients treated with panitumumab who developed skin toxicities and have been biopsied for skin rash.
Patients Treated With Erlotinib (E) Patients treated with erlotinib who developed skin toxicities and have been biopsied for a skin rash.

Participant Flow:   Overall Study
    Patients Treated With Lapatinib (L)     Patients Treated With Cetuximab (C)     Patients Treated With Panitumumab (P)     Patients Treated With Erlotinib (E)  
STARTED     8     8     8     8  
COMPLETED     8     8     8     8  
NOT COMPLETED     0     0     0     0  



  Baseline Characteristics
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Reporting Groups
  Description
Patients Treated With Lapatinib (L) Patients treated with lapatinib who developed skin toxicities and have been biopsied for skin rash.
Patients Treated With Cetuximab (C) Patients treated with cetuximab who developed skin toxicities and have been biopsied for skin rash.
Patients Treated With Panitumumab (P) Patients treated with panitumumab who developed skin toxicities and have been biopsied for skin rash.
Patients Treated With Erlotinib (E) Patients treated with erlotinib who developed skin toxicities and have been biopsied for a skin rash.
Total Total of all reporting groups

Baseline Measures
    Patients Treated With Lapatinib (L)     Patients Treated With Cetuximab (C)     Patients Treated With Panitumumab (P)     Patients Treated With Erlotinib (E)     Total  
Number of Participants  
[units: participants]
 		  8     8     8     8     32  
Age  
[units: years]
Mean ( Full Range ) 		  55.7  
  ( 17 to 62 )   		  54.5  
  ( 34 to 72 )   		  65  
  ( 39 to 81 )   		  66.7  
  ( 46 to 81 )   		  60.35  
  ( 17 to 81 )  
Gender  
[units: participants]
 		         
Female     7     4     5     2     18  
Male     1     4     3     6     14  
Region of Enrollment  
[units: participants]
 		         
United States     8     8     8     8     32  



  Outcome Measures

1.  Primary:   Differences in Histologic Alterations in Rash Caused by Lapatinib, a Dual HER1/2 Inhibitor (HER1/2i), and the Single HER1 Inhibitors (HER1i) Cetuximab, Erlotinib,and Panitumumab.   [ Time Frame: 6 months ]
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  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
Small sample size  


Results Point of Contact:  
Name/Title: Mario Lacouture, MD
Organization: Northwestern University
phone: 212-610-0079
e-mail: LacoutuM@mskcc.org


Publications of Results:

Other Publications:


Responsible Party: Mario Lacouture, MD, Northwestern University, Department of Dermatology
ClinicalTrials.gov Identifier: NCT00709878     History of Changes
Other Study ID Numbers: GSK-Lapatinib
Study First Received: July 1, 2008
Results First Received: August 27, 2010
Last Updated: December 6, 2010
Health Authority: United States: Institutional Review Board