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

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ClinicalTrials.gov Identifier: NCT00709878
Recruitment Status : Completed
First Posted : July 3, 2008
Results First Posted : September 23, 2010
Last Update Posted : March 17, 2015
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
Northwestern University

Study Description
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Brief Summary:
The purpose of this study is to characterize the microscopic findings of skin rash associated with the use of chemotherapeutic anticancer agents known as epidermal growth factor inhibitors (EGFRIs).

Condition or disease Intervention/treatment
Skin Rash Procedure: Skin Biopsy of Skin Rash Secondary to EGFRI Use

Detailed Description:
Epidermal growth factor (EGF) and its receptor, the EGFR, are known to be key drivers in cellular proliferation and survival. Malignant tumors result from uncontrolled cell proliferation. The use of drugs which target the EGF receptor has offered patients with non-small cell lung cancer, pancreatic cancer, head and neck cancer, and colorectal cancer additional targeted anti-cancer therapy in addition to their chemotherapeutic regimens. As a result of increased use of these EGFR inhibitors, adverse events have emerged involving the skin, hair, nails and eyes. While the EGFR inhibitors block the signal transduction that interfere with cellular proliferation and survival of cancerous cells, they also affect the normal EGF function in the skin (papulopustular rash), hair, and nails. In this study, we seek to histologically characterize the papulopustular rash in patients who have been treated with lapatinib and compare our findings with those associated with three other EGFRIs, cetuximab, erlotinib and panitumumab.

Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy Rashes

Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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
Skin tissue biopsies.

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients selected for this study were treated with lapatinib, erlotinib, panitumumab or cetuximab, developed skin toxicities and were biopsied as standard of care for skin rash at the Department of Dermatology, Northwestern University.
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
GlaxoSmithKline
Investigators
Principal Investigator: Mario Lacouture, MD Northwestern University, Department of Dermatology
More Information
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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
First Posted: July 3, 2008    Key Record Dates
Results First Posted: September 23, 2010
Last Update Posted: March 17, 2015
Last Verified: February 2015

Keywords provided by Northwestern University:
skin rash, lapatinib, cetuximab, erlotinib, panitumumab

Additional relevant MeSH terms:
Exanthema
Skin Diseases
Lapatinib
Cetuximab
Erlotinib Hydrochloride
 Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action