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TerminatedNCT01137162Updated Jul 22, 2016

Clinical and Pathologic Studies of Patients Undergoing Treatment With EGFR Inhibitors

An observational study in Anal, Colon, and Rectal Cancers, Head and Neck Cancer and Lung Cancer, sponsored by Stanford University. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-07-22.

Sponsored by Stanford University · Observational

Why this study was terminated
Low Accrual
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
10
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • 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)
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's enrollment of 10 is below the median of 189 across 1,514 observational studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Stanford University is the lead sponsor of 2,117 studies on the registry; 425 are open to participants now.

Of its 259 completed or terminated interventional studies of FDA-regulated products, 197 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

Exclusion Criteria:

  • None
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
10 participants (actual)
Biospecimen retention
Samples without dna
06

Study locations

1 site
  • Stanford University School of Medicine
    Stanford, California 94305, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 22, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT01137162
Lead sponsor
Stanford University
Responsible party
Sponsor
First posted
Jun 4, 2010
Start date
Aug 2008
Primary completion
Oct 2011
Completion
Oct 2011
Last update
Jul 22, 2016

Study contacts

George Albert Fisher M.D. Ph.D.
principal investigator · Stanford University
Russell Pachynski
principal investigator · Stanford University
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.

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