NCT00483457

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 33 (actual)
• Sponsor: Vanderbilt-Ingram Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
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

Timeline

• Start date: 2006-02-01
• Primary completion: 2008-11-01
• Completion: 2008-11-01
• First posted: 2007-06-07
• Last updated: 2012-09-03

Locations

1 site across 1 country: United States