An observational study in Solid Tumor, sponsored by Vanderbilt-Ingram Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-09-03.
Sponsored by Vanderbilt-Ingram Cancer Center · Observational
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:
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.
Vanderbilt-Ingram Cancer Center is the lead sponsor of 220 studies on the registry; 32 are open to participants now.
Of its 23 completed or terminated interventional studies of FDA-regulated products, 18 (78%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients must be ≥ 18 years of age, have the diagnosis of a malignancy for which they are considering therapy with an inhibitor of the EGFR pathway, have no severe underlying skin disorder, must not have a bleeding diathesis that would preclude safe biopsy and patients on coumadin must not have an INR > 3.0 at time of biopsy.
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
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
enzyme inhibitor therapy
protein expression analysis
immunohistochemistry staining method
laboratory biomarker analysis
biopsy
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
This study is completed, as verified in Aug 2012. You cannot join it, but the record below documents what was studied.
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Vanderbilt-Ingram Cancer Center