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

NCT ID: NCT00483457

Last Updated: 2012-09-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 33 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-02-28
• Study Completion Date: 2008-11-30

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.

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.

Conditions

Solid Tumor

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

enzyme inhibitor therapy

enzyme inhibitor therapy

Intervention Type: DRUG

protein expression analysis

protein expression analysis

Intervention Type: GENETIC

immunohistochemistry staining method

immunohistochemistry staining method

Intervention Type: OTHER

laboratory biomarker analysis

laboratory biomarker analysis

Intervention Type: OTHER

biopsy

biopsy

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Vanderbilt-Ingram Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Laura W. Goff, MD

Assistant Professor of Medicine; Associate Director, Hematology/Oncology Fellowship Program; Medical Oncologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Laura Goff, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt-Ingram Cancer Center

Locations

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

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