- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01137162
Clinical and Pathologic Studies of Patients Undergoing Treatment With EGFR Inhibitors
July 20, 2016 updated by: Stanford University
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.
Study Overview
Status
Terminated
Conditions
- Head and Neck Cancer
- Colorectal Neoplasms
- Lung Cancer
- Colon Cancer
- Colonic Neoplasms
- Head and Neck Cancers
- Anal, Colon, and Rectal Cancers
- Colon/Rectal Cancer
- Colon/Rectal Cancer Colon Cancer
- Colon/Rectal Cancer Rectal Cancer
- Colon/Rectal Cancer Anal Cancer
- 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
Enrollment (Actual)
10
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Stanford, California, United States, 94305
- Stanford University School of Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with adenocarcinoma
Description
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:
- None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Russell Pachynski, Stanford University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2008
Primary Completion (Actual)
October 1, 2011
Study Completion (Actual)
October 1, 2011
Study Registration Dates
First Submitted
June 1, 2010
First Submitted That Met QC Criteria
June 3, 2010
First Posted (Estimate)
June 4, 2010
Study Record Updates
Last Update Posted (Estimate)
July 22, 2016
Last Update Submitted That Met QC Criteria
July 20, 2016
Last Verified
July 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Respiratory Tract Diseases
- Lung Diseases
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Anus Diseases
- Neoplasms
- Head and Neck Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Colorectal Neoplasms
- Rectal Neoplasms
- Small Cell Lung Carcinoma
- Colonic Neoplasms
- Anus Neoplasms
Other Study ID Numbers
- VAR0041
- 12418 (Other Identifier: SU)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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