Clinical trial NCT00709878: Histological Characterization and Differentiation of Rash From Other Epidermal Growth Factor Receptor (EGFR) Inhibitors
Official title: Histological Characterization and Differentiation of Rash From Other EGFR Inhibitors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Skin Rash
Keywords: skin rash, lapatinib, cetuximab, erlotinib, panitumumab
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2008-07-03
Enrollment: 32
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: 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.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Northwestern University, Department of Dermatology
name: Mario Lacouture, MD
role: PRINCIPAL_INVESTIGATOR
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