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

NCT00483457 | Completed DMC

• 3 other identifiers: VICC GI 0561VU-VICC-GI-0561VU-VICC-IRB-051020
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Solid Tumor

Keywords

unspecified adult solid tumor, protocol specific

Outcome Measures

Primary Outcomes (1)

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

  baseline and at 6 weeks

Secondary Outcomes (3)

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

  at 6 weeks

• Comparison of changes in the EGFR pathway with grade of rash

  at 6 weeks

• Comparison of changes in EGFR pathway effectors in the skin with serum TGFα levels as assessed by immunohistochemistry and western blot

  at 6 weeks

Interventions

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Vanderbilt-Ingram Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Interventions

Immunohistochemistry; Biopsy

Intervention Hierarchy (Ancestors)

Histocytochemistry; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Investigative Techniques; Immunologic Techniques; Cytodiagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative

Study Officials

• Laura Goff, MD

  Vanderbilt-Ingram Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine; Associate Director, Hematology/Oncology Fellowship Program; Medical Oncologist

Study Record Dates

• First Submitted: June 6, 2007
• First Posted: June 7, 2007
• Study Start: February 1, 2006
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: September 3, 2012

Record last verified: 2012-08

Locations

US (1)