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

Solid Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00483457
• Other study ID #: VICC GI 0561
• Secondary ID: VU-VICC-GI-0561V
• Status: Completed
• Phase: N/A
• First received: June 6, 2007
• Last updated: August 31, 2012
• Start date: February 2006
• Est. completion date: November 2008

Study information

• Verified date: August 2012
• Source: Vanderbilt-Ingram Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

• 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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Solid Tumor

Intervention

Drug:
• enzyme inhibitor therapy
enzyme inhibitor therapy

Genetic:
• protein expression analysis
protein expression analysis

Other:
• immunohistochemistry staining method
immunohistochemistry staining method
• laboratory biomarker analysis
laboratory biomarker analysis

Procedure:
• biopsy
biopsy

Locations

Country	Name	City	State
United States	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt-Ingram Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effects of EGFR inhibitors on the EGFR pathway in the skin prior to and after receiving EGFR inhibitors		baseline and at 6 weeks	No
Secondary	Comparison of the effects of EGFR tyrosine kinase inhibitors vs monoclonal antibodies on the EGFR pathway in the skin		at 6 weeks	No
Secondary	Comparison of changes in the EGFR pathway with grade of rash		at 6 weeks	No
Secondary	Comparison of changes in EGFR pathway effectors in the skin with serum TGFa levels as assessed by immunohistochemistry and western blot		at 6 weeks	No