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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

June 1, 2010
August 7, 2012
August 2008
October 2011   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01137162 on ClinicalTrials.gov Archive Site
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Clinical and Pathologic Studies of Patients Undergoing Treatment With EGFR Inhibitors
Clinical and Pathologic Studies of Patients Undergoing Treatment With EGFR Inhibitors

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.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Retention:   Samples Without DNA
Description:

skin biopsies and blood

Non-Probability Sample

Patients with adenocarcinoma

  • 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)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
10
October 2011
October 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01137162
VAR0041, 12418
Not Provided
Stanford University
Stanford University
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Principal Investigator: George Albert Fisher M.D. Ph.D. Stanford University
Principal Investigator: Russell Pachynski Stanford University
Stanford University
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP