Trials Sponsors Conditions Drugs Pricing

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 therapyDrug

enzyme inhibitor therapy

protein expression analysisGenetic

protein expression analysis

immunohistochemistry staining method

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodProbability 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

Sponsors & Collaborators

Vanderbilt-Ingram Cancer Center
Otherlead
National Cancer Institute (NCI)
NIHcollaborator

Study Sites (1)

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232, United States

MeSH Terms

Interventions

ImmunohistochemistryBiopsy

Intervention Hierarchy (Ancestors)

HistocytochemistryCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisHistological TechniquesInvestigative TechniquesImmunologic TechniquesCytodiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, Operative

Study Officials

Laura Goff, MD
Vanderbilt-Ingram Cancer Center
PRINCIPAL INVESTIGATOR

Enrollment

33 participants (actual enrollment reported by the registry).

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 2006

Date type not reported

This date has not been verified as actual or estimated.

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Interventions

Eligibility Criteria

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Interventions

Eligibility Criteria

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations