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OpenTrials
Completed

NCT Number: NCT00483457

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Enzyme Inhibitor Therapy

Drug

enzyme inhibitor therapy

protein expression analysis

Genetic

protein expression analysis

immunohistochemistry staining method

Other

immunohistochemistry staining method

laboratory biomarker analysis

Other

laboratory biomarker analysis

Biopsy

Procedure

biopsy

Primary outcomes

  1. 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

Secondary outcomes

  1. Comparison of the effects of EGFR tyrosine kinase inhibitors vs monoclonal antibodies on the EGFR pathway in the skin

    Time frame: at 6 weeks

  2. Comparison of changes in the EGFR pathway with grade of rash

    Time frame: at 6 weeks

  3. 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

Sponsors and collaborators

Lead sponsor

Vanderbilt-Ingram Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Jun 7, 2007
Registry last updated
Sep 3, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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