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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Laura W. Goff, MD, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier:
NCT00483457
First received: June 6, 2007
Last updated: August 31, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention
Solid Tumor
Drug: enzyme inhibitor therapy
Genetic: protein expression analysis
Other: immunohistochemistry staining method
Other: laboratory biomarker analysis
Procedure: biopsy

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Pilot Study of the Effects of Epidermal Growth Factor Receptor (EGFR) Inhibitors on the EGFR in Skin Lesions

Resource links provided by NLM:


Further study details as provided by Vanderbilt-Ingram Cancer Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Comparison of the effects of EGFR tyrosine kinase inhibitors vs monoclonal antibodies on the EGFR pathway in the skin [ Time Frame: at 6 weeks ] [ Designated as safety issue: No ]
  • Comparison of changes in the EGFR pathway with grade of rash [ Time Frame: at 6 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 33
Study Start Date: February 2006
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: enzyme inhibitor therapy
    enzyme inhibitor therapy
    Other Name: enzyme inhibitor therapy
    Genetic: protein expression analysis
    protein expression analysis
    Other Name: protein expression analysis
    Other: immunohistochemistry staining method
    immunohistochemistry staining method
    Other Name: immunohistochemistry staining method
    Other: laboratory biomarker analysis
    laboratory biomarker analysis
    Other Name: laboratory biomarker analysis
    Procedure: biopsy
    biopsy
    Other Name: biopsy
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00483457

Locations
United States, Tennessee
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
Investigators
Principal Investigator: Laura Goff, MD Vanderbilt-Ingram Cancer Center
  More Information

No publications provided

Responsible Party: Laura W. Goff, MD, Assistant Professor of Medicine; Associate Director, Hematology/Oncology Fellowship Program; Medical Oncologist, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT00483457     History of Changes
Other Study ID Numbers: VICC GI 0561, VU-VICC-GI-0561, VU-VICC-IRB-051020
Study First Received: June 6, 2007
Last Updated: August 31, 2012
Health Authority: United States: Federal Government

Keywords provided by Vanderbilt-Ingram Cancer Center:
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Enzyme Inhibitors
Mitogens
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Mitosis Modulators

ClinicalTrials.gov processed this record on July 22, 2014