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

Vanderbilt-Ingram Cancer Center33 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Solid Tumor

Interventions

enzyme inhibitor therapyDRUG

enzyme inhibitor therapy

protein expression analysisGENETIC

protein expression analysis

immunohistochemistry staining methodOTHER

immunohistochemistry staining method

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States

Outcomes

Primary Outcomes

Effects of EGFR inhibitors on the EGFR pathway in the skin prior to and after receiving EGFR inhibitors

Time frame: baseline and at 6 weeks

Secondary Outcomes

Comparison of the effects of EGFR tyrosine kinase inhibitors vs monoclonal antibodies on the EGFR pathway in the skin

Time frame: at 6 weeks

Comparison of changes in the EGFR pathway with grade of rash

Time frame: at 6 weeks

Comparison of changes in EGFR pathway effectors in the skin with serum TGFα levels as assessed by immunohistochemistry and western blot

Time frame: at 6 weeks

Data from ClinicalTrials.gov

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