View Clinical Trial (Medical Research Study)
Regenecare® in the Treatment of Skin Rash Associated With Cetuximab (Erbitux®) or Other EGFR Treated Cancer Patients
| City: |
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Harvey |
| State: |
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Illinois |
| Zip Code: |
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60426 |
| Conditions: |
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Dermatologic Complications - Unspecified Adult Solid Tumor, Protocol Specific |
| Purpose: |
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RATIONALE: Regenecare® wound gel may help relieve pain and itching in patients who develop
an acne-like rash while undergoing treatment with cetuximab or another epidermal growth
factor receptor inhibitor for cancer.
PURPOSE: This clinical trial is studying how well Regenecare® wound gel works in treating
rash in patients receiving cetuximab or another epidermal growth factor receptor inhibitor
therapy for cancer.
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| Study Summary: |
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OBJECTIVES:
Primary
- Determine the efficacy of Regenecare® wound gel in alleviating pain and itching in
patients who develop an acneiform rash while undergoing treatment with cetuximab or
other EGFR inhibitor therapy for cancer.
Secondary
- Determine the efficacy of this drug in reducing the severity of rash in these patients.
- Determine the efficacy of this drug in reducing the redness and appearance of the rash
in these patients.
- Determine the tolerability of this drug in these patients.
OUTLINE: This is a prospective study.
- Observation: Patients undergo evaluation by full-face photography prior to development
of skin rash (baseline). While undergoing concurrent cancer therapy, patients
self-monitor for the appearance of an acneiform rash. Upon initial onset of rash,
patients proceed to treatment.
- Treatment: Patients apply topical Regenecare® wound gel to the face ≥ 4 times daily.
Treatment continues for 4 weeks in the absence of unacceptable toxicity.
Patients are evaluated weekly by facial examination, full-face photography, and patient
satisfaction questionnaires.
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| Criteria: |
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DISEASE CHARACTERISTICS:
- Diagnosis of cancer
- Starting treatment with cetuximab or other EGFR inhibitor (e.g., erlotinib
hydrochloride) on another clinical trial
PATIENT CHARACTERISTICS:
- Not pregnant or nursing
- No known history of hypersensitivity to amine-type local anesthetics or to other
components of MPM Regenecare® wound gel
- No other concurrent, serious skin disorders (i.e., scleroderma or psoriasis) that
would interfere with assessment of EGFR inhibitor-induced rash
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No other concurrent topical facial creams or lotions
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| NCT ID: |
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NCT00498992 |
| Primary Contact: |
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Study Chair
Mark F. Kozloff, MD
Ingalls Cancer Care Center at Ingalls Memorial Hospital
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| Backup Contact: |
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N/A |
| Location Contact: |
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Harvey, Illinois 60426
United States
Clinical Trials Office - Ingalls Cancer Care Center at Ingalls
Phone: 708-915-4673
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 19, 2013 |
| Modifications to this listing: |
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