Clinical and Pathologic Studies of Patients Undergoing Treatment With EGFR Inhibitors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-08-31

Study Completion Date

2011-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Cetuximab, erlotinib, and panitumumab are all recently FDA approved epidermal growth factor receptor (EGFR) inhibitors that treat a wide variety of tumor types, such as colon, lung, and head and neck. Blockade of the EGFR results in inhibition of multiple downstream pathways, leading to slowed tumor growth. In addition, these inhibitors may enhance anti-tumor immune responses through uncharacterized mechanisms. While producing significant responses in many settings, EGFR inhibitors also result in significant skin toxicity (rash) in a high percentage of patients. Multiple studies have correlated the presence and severity of rash with clinical response. Unfortunately, severe rash can often lead to dose delays, reductions, or even discontinuation of EGFR inhibitors, thus limiting their efficacy. The mechanism of both the rash and its correlation with tumor response is poorly understood. Skin biopsies display a robust leukocyte infiltrate, but a systematic analysis of the type of infiltrating leukocytes, activation state, or homing receptor expression has not been performed. Chemokines and chemokine receptors control leukocyte trafficking to the skin and other tissue sites, and defined receptor profiles for skin-, gut-, and lung-homing leukocytes are well established. In this study, the investigators propose to evaluate the homing phenotype of leukocytes from peripheral blood and skin biopsies of patients receiving EGFR inhibitors. The investigators will use RNA microarrays to evaluate the expression of chemokines and other key genes regulated in skin during treatment. The investigators will utilize in vitro methods to investigate effects of EGFR inhibitors on imprinting of T cell tissue-specific homing receptors. The investigators will examine correlations among the pathologic data, clinical findings, and tumor response. If validated, peripheral blood evaluation could potentially be used as a predictive indicator for patients receiving EGFR inhibitors. This study may also identify novel targets for limiting skin toxicity while receiving EGFR inhibitors, thus allowing maximal dosing and clinical response from these agents.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Stereotactic Radiosurgery or Other Local Ablation Then Erlotinib in Epidermal Growth Factor Receptor (EGFR)

NCT01573702

Non Small Cell Lung Cancer

COMPLETED PHASE2

Combination of Cetuximab With Afatinib for Patient With EGFR Mutated Lung Cancer

NCT02716311

Non Small Cell Lung Cancer

COMPLETED PHASE2

Study of Erlotinib (Tarceva®) in Combination With OSI-906 in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) With Activating Mutations of the Epidermal Growth Factor Receptor (EGFR) Gene

NCT01221077

NSCLC Non Small Cell Lung Cancer

COMPLETED PHASE2

Erlotinib in Patients With Resected, Early Stage NSCLC With Confirmed Mutations in the EGFR

NCT00567359

Non-small Cell Lung Cancer

COMPLETED PHASE2

Rapid Plasma Genotyping For Early Initiation Of Erlotinib In EGFR Mutant Lung Cancer

NCT02770014

Epidermal Growth Factor Receptor Non-Small Cell Lung Cancer

TERMINATED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anal, Colon, and Rectal Cancers Head and Neck Cancer Lung Cancer Colon Cancer Colonic Neoplasms Colorectal Neoplasms Colon/Rectal Cancer Colon/Rectal Cancer Colon Cancer Colon/Rectal Cancer Rectal Cancer Colon/Rectal Cancer Anal Cancer Head and Neck Cancers Head and Neck Cancers Lip Head and Neck Cancers Oral Cavity Head and Neck Cancers Nasopharynx Head and Neck Cancers Oropharynx Head and Neck Cancers Hypopharynx Head and Neck Cancers Larynx Head and Neck Cancers Trachea Lung Cancer Non-Small Cell Cancer (NSCLC) Lung Cancer Small Cell Lung Cancer (SCLC)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients are eligible if they have histologically proven adenocarcinoma, are planning to or currently undergoing treatment with an anti-EGFR (epidermal growth factor receptor) therapy, and are 18 years of age or older.