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


N/A
18 Years
N/A
Not Enrolling
Both
Solid Tumor

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Trial Information

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


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.

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

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Effects of EGFR inhibitors on the EGFR pathway in the skin prior to and after receiving EGFR inhibitors

Outcome Time Frame:

baseline and at 6 weeks

Safety Issue:

No

Principal Investigator

Laura Goff, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Vanderbilt-Ingram Cancer Center

Authority:

United States: Federal Government

Study ID:

VICC GI 0561

NCT ID:

NCT00483457

Start Date:

February 2006

Completion Date:

November 2008

Related Keywords:

  • Solid Tumor
  • unspecified adult solid tumor, protocol specific

Name

Location

Vanderbilt-Ingram Cancer CenterNashville, Tennessee  37232-6838