Clinical and Pathologic Studies of Patients Undergoing Treatment With EGFR Inhibitors

This study has been terminated.
(Low Accrual)
Sponsor:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01137162
First received: June 1, 2010
Last updated: August 7, 2012
Last verified: August 2012
  Purpose

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
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
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical and Pathologic Studies of Patients Undergoing Treatment With EGFR Inhibitors

Resource links provided by NLM:


Further study details as provided by Stanford University:

Biospecimen Retention:   Samples Without DNA

skin biopsies and blood


Enrollment: 10
Study Start Date: August 2008
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with adenocarcinoma

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01137162

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

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01137162     History of Changes
Other Study ID Numbers: VAR0041, 12418
Study First Received: June 1, 2010
Last Updated: August 7, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 20, 2014