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Clinical Trials/NCT00709878
NCT00709878
Completed
Not Applicable

Histological Characterization and Differentiation of Rash From Other EGFR Inhibitors

Northwestern University1 site in 1 country32 target enrollmentApril 2008
ConditionsSkin Rash

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Skin Rash
Sponsor
Northwestern University
Enrollment
32
Locations
1
Primary Endpoint
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.
Status
Completed
Last Updated
11 years ago

Overview

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).

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.

Registry
clinicaltrials.gov
Start Date
April 2008
End Date
August 2010
Last Updated
11 years ago
Study Type
Observational
Sex
All

Investigators

Eligibility 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.

Outcomes

Primary Outcomes

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

Study Sites (1)

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