Effects of Epidermal Growth Factor Receptor Inhibitor Therapy in the Skin of Cancer Patients
NCT ID: NCT00483457
Last Updated: 2012-09-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
33 participants
OBSERVATIONAL
2006-02-28
2008-11-30
Brief Summary
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PURPOSE: This laboratory study is looking at the effects of EGFR inhibitors in the skin of cancer patients.
Detailed Description
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* 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
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Keywords
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Study Design
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CASE_ONLY
PROSPECTIVE
Interventions
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enzyme inhibitor therapy
enzyme inhibitor therapy
protein expression analysis
protein expression analysis
immunohistochemistry staining method
immunohistochemistry staining method
laboratory biomarker analysis
laboratory biomarker analysis
biopsy
biopsy
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Vanderbilt-Ingram Cancer Center
OTHER
Responsible Party
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Laura W. Goff, MD
Assistant Professor of Medicine; Associate Director, Hematology/Oncology Fellowship Program; Medical Oncologist
Principal Investigators
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Laura Goff, MD
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt-Ingram Cancer Center
Locations
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Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Countries
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Other Identifiers
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VU-VICC-GI-0561
Identifier Type: -
Identifier Source: secondary_id
VU-VICC-IRB-051020
Identifier Type: -
Identifier Source: secondary_id
VICC GI 0561
Identifier Type: -
Identifier Source: org_study_id