Histological Characterization and Differentiation of Rash From Other Epidermal Growth Factor Receptor (EGFR) Inhibitors
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00709878 |
Recruitment Status :
Completed
First Posted : July 3, 2008
Results First Posted : September 23, 2010
Last Update Posted : March 17, 2015
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment |
---|---|
Skin Rash | Procedure: Skin Biopsy of Skin Rash Secondary to EGFRI Use |
Study Type : | Observational |
Actual Enrollment : | 32 participants |
Observational Model: | Cohort |
Time Perspective: | Retrospective |
Official Title: | Histological Characterization and Differentiation of Rash From Other EGFR Inhibitors |
Study Start Date : | April 2008 |
Actual Primary Completion Date : | August 2010 |
Actual Study Completion Date : | August 2010 |

Group/Cohort | Intervention/treatment |
---|---|
L
Patients treated with lapatinib who developed skin toxicities and have been biopsied for skin rash.
|
Procedure: Skin Biopsy of Skin Rash Secondary to EGFRI Use
Patients who were treated with lapatinib, cetuximab, panitumumab or erlotinib who subsequently developed a skin rash have been biopsied as standard of care. The biopsies will be used for this study. |
C
Patients treated with cetuximab who developed skin toxicities and have been biopsied for skin rash.
|
Procedure: Skin Biopsy of Skin Rash Secondary to EGFRI Use
Patients who were treated with lapatinib, cetuximab, panitumumab or erlotinib who subsequently developed a skin rash have been biopsied as standard of care. The biopsies will be used for this study. |
P
Patients treated with panitumumab who developed skin toxicities and have been biopsied for skin rash.
|
Procedure: Skin Biopsy of Skin Rash Secondary to EGFRI Use
Patients who were treated with lapatinib, cetuximab, panitumumab or erlotinib who subsequently developed a skin rash have been biopsied as standard of care. The biopsies will be used for this study. |
E
Patients treated with erlotinib who developed skin toxicities and have been biopsied for a skin rash.
|
Procedure: Skin Biopsy of Skin Rash Secondary to EGFRI Use
Patients who were treated with lapatinib, cetuximab, panitumumab or erlotinib who subsequently developed a skin rash have been biopsied as standard of care. The biopsies will be used for this study. |
- 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 ]
Biospecimen Retention: Samples With DNA

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Patients treated with lapatinib who developed skin toxicities and were biopsied.
- Patients treated with erlotinib, cetuximab, or panitumumab who have been biopsied for skin rash.
Exclusion Criteria:
- Patients who do not fit above criteria.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00709878
United States, Illinois | |
Northwestern University | |
Chicago, Illinois, United States, 60611 |
Principal Investigator: | Mario Lacouture, MD | Northwestern University, Department of Dermatology |
Other Publications:
Responsible Party: | Mario Lacouture, MD, Northwestern University, Department of Dermatology |
ClinicalTrials.gov Identifier: | NCT00709878 |
Other Study ID Numbers: |
GSK-Lapatinib |
First Posted: | July 3, 2008 Key Record Dates |
Results First Posted: | September 23, 2010 |
Last Update Posted: | March 17, 2015 |
Last Verified: | February 2015 |
skin rash, lapatinib, cetuximab, erlotinib, panitumumab |
Exanthema Skin Diseases |