Clinical and Pathologic Studies of Patients Undergoing Treatment With EGFR Inhibitors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01137162
Recruitment Status : Terminated (Low Accrual)
First Posted : June 4, 2010
Last Update Posted : July 22, 2016
Information provided by (Responsible Party):
Stanford University

Brief Summary:
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.

Condition or disease
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 Type : Observational
Actual Enrollment : 10 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical and Pathologic Studies of Patients Undergoing Treatment With EGFR Inhibitors
Study Start Date : August 2008
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

Biospecimen Retention:   Samples Without DNA
skin biopsies and blood

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with adenocarcinoma

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.

Exclusion Criteria:

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01137162

United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Principal Investigator: George Albert Fisher M.D. Ph.D. Stanford University
Principal Investigator: Russell Pachynski Stanford University

Responsible Party: Stanford University Identifier: NCT01137162     History of Changes
Other Study ID Numbers: VAR0041
12418 ( Other Identifier: SU )
First Posted: June 4, 2010    Key Record Dates
Last Update Posted: July 22, 2016
Last Verified: July 2016

Additional relevant MeSH terms:
Lung Neoplasms
Rectal Neoplasms
Head and Neck Neoplasms
Colonic Neoplasms
Small Cell Lung Carcinoma
Colorectal Neoplasms
Anus Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Colonic Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Anus Diseases