Clinical and Pathologic Studies of Patients Undergoing Treatment With EGFR Inhibitors
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| City: |
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Stanford |
| State: |
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California |
| Zip Code: |
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94305 |
| Conditions: |
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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 - |
| Purpose: |
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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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| Study Summary: |
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| Criteria: |
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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
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| NCT ID: |
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NCT01137162 |
| Primary Contact: |
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Principal Investigator
George Albert Fisher M.D. Ph.D.
Stanford University
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| Backup Contact: |
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N/A |
| Location Contact: |
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Stanford, California 94305
United States
There is no listed contact information for this specific location.
Site Status: N/A |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 24, 2013 |
| Modifications to this listing: |
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