Effects of Epidermal Growth Factor Receptor Inhibitor Therapy in the Skin of Cancer Patients
|ClinicalTrials.gov Identifier: NCT00483457|
Recruitment Status : Completed
First Posted : June 7, 2007
Last Update Posted : September 3, 2012
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.
|Condition or disease||Intervention/treatment|
|Solid Tumor||Drug: enzyme inhibitor therapy Genetic: protein expression analysis Other: immunohistochemistry staining method Other: laboratory biomarker analysis Procedure: biopsy|
- 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|
|Actual Enrollment :||33 participants|
|Official Title:||Pilot Study of the Effects of Epidermal Growth Factor Receptor (EGFR) Inhibitors on the EGFR in Skin Lesions|
|Study Start Date :||February 2006|
|Primary Completion Date :||November 2008|
|Study Completion Date :||November 2008|
Drug: enzyme inhibitor therapy
- 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 ]
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00483457
|United States, Tennessee|
|Vanderbilt-Ingram Cancer Center|
|Nashville, Tennessee, United States, 37232|
|Principal Investigator:||Laura Goff, MD||Vanderbilt-Ingram Cancer Center|