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

Vanderbilt University Medical Center

Status: Completed

Conditions: Solid Tumor

Treatments: Other: immunohistochemistry staining method; Procedure: biopsy; Drug: enzyme inhibitor therapy; Genetic: protein expression analysis; Other: laboratory biomarker analysis

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT00483457

VU-VICC-GI-0561

VICC GI 0561

VU-VICC-IRB-051020

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 33 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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