Effects of Epidermal Growth Factor Receptor Inhibitor Therapy in the Skin of Cancer Patients

Study Overview
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Brief Summary
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RATIONALE: Studying samples of tissue and blood in the laboratory from patients with cancer receiving epidermal growth factor receptor (EGFR) inhibitors may help doctors understand the effects of EGFR inhibitor therapy in the skin. PURPOSE: This laboratory study is looking at the effects of EGFR inhibitors in the skin of cancer patients.

Detailed Description
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OBJECTIVES: Determine the effects of EGFR inhibitors on the EGFR pathway in the skin of cancer patients prior to and after receiving EGFR inhibitors (i.e., tyrosine kinase inhibitors and monoclonal antibodies). Compare the effects of EGFR tyrosine kinase inhibitors vs monoclonal antibodies on the EGFR pathway in the skin of these patients. Compare changes in the EGFR pathway with grade of rash in these patients. Compare changes in EGFR pathway effectors in the skin with serum TGFα levels in these patients. OUTLINE: This is a pilot study. Patients undergo skin punch biopsies and blood sample collection at baseline, within 1 week of developing skin rash, and 6 weeks after beginning treatment. Samples are analyzed by immunohistochemistry and western blot for phosphorylated MAP kinase, AKT, and EGF levels and TGFα levels. Patients also complete diagrams to indicate locations of the rash once weekly during the first 6 weeks of treatment.

Official Title
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Pilot Study of the Effects of Epidermal Growth Factor Receptor (EGFR) Inhibitors on the EGFR in Skin Lesions

Conditions
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Solid Tumor

Intervention / Treatment
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* Drug: enzyme inhibitor therapy
* Genetic: protein expression analysis
* Other: immunohistochemistry staining method
* Other: laboratory biomarker analysis
* Procedure: biopsy


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Diagnosis of a malignancy for which therapy on or off a clinical trial with an inhibitor of the EGFR pathway is under consideration The therapy under consideration may be monotherapy or combined with other therapies as long as other therapies do not typically cause a rash PATIENT CHARACTERISTICS: INR ≤ 3.0 (for patients receiving concurrent warfarin) No severe underlying skin disorder (e.g., toxic epidermal necrolysis or severe dermatitis) that would preclude study treatment No bleeding diatheses that would preclude safe biopsy No allergy to lidocaine or similar local anesthetics PRIOR CONCURRENT THERAPY: See Disease Characteristics

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: enzyme inhibitor therapy|enzyme inhibitor therapy|
|Genetic: protein expression analysis|protein expression analysis|
|Other: immunohistochemistry staining method|immunohistochemistry staining method|
|Other: laboratory biomarker analysis|laboratory biomarker analysis|
|Procedure: biopsy|biopsy|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects of EGFR inhibitors on the EGFR pathway in the skin prior to and after receiving EGFR inhibitors |  | baseline and at 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of the effects of EGFR tyrosine kinase inhibitors vs monoclonal antibodies on the EGFR pathway in the skin |  | at 6 weeks | 
| Comparison of changes in the EGFR pathway with grade of rash |  | at 6 weeks | 
| Comparison of changes in EGFR pathway effectors in the skin with serum TGFα levels as assessed by immunohistochemistry and western blot |  | at 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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unspecified adult solid tumor, protocol specific