Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2025-12-30 @ 8:03 AM
Study NCT ID:
NCT00483457
Status:
COMPLETED
Last Update Posted:
2012-09-03
First Post:
2007-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Epidermal Growth Factor Receptor Inhibitor Therapy in the Skin of Cancer Patients
Sponsor:
Vanderbilt-Ingram Cancer Center
Organization:
Study Overview
Official Title:
Pilot Study of the Effects of Epidermal Growth Factor Receptor (EGFR) Inhibitors on the EGFR in Skin Lesions
Status:
COMPLETED
Status Verified Date:
2012-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
* 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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: