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
  Purpose

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 Intervention
Skin Rash
Procedure: Skin Biopsy of Skin Rash Secondary to EGFRI Use

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Histological Characterization and Differentiation of Rash From Other EGFR Inhibitors

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Skin tissue biopsies.


Enrollment: 32
Study Start Date: April 2008
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.

  Eligibility

Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

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

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

ClinicalTrials.gov processed this record on October 29, 2014