Regenecare® in the Treatment of Skin Rash Associated With Cetuximab (Erbitux®) or Other EGFR Treated Cancer Patients
18 Years
N/A
Both
Dermatologic Complications, Unspecified Adult Solid Tumor, Protocol Specific
Trial Information
Regenecare® in the Treatment of Skin Rash Associated With Cetuximab (Erbitux®) or Other EGFR Treated Cancer Patients
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.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Primary Purpose: Supportive Care
Outcome Measure:
Efficacy of Regenecare® wound gel, in terms of alleviating pain and itching
Principal Investigator
Mark F. Kozloff, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Ingalls Memorial Hospital
Authority:
Unspecified
Study ID:
CDR0000553120
NCT ID:
NCT00498992
Start Date:
July 2006
Completion Date:
Related Keywords:
- Dermatologic Complications
- Unspecified Adult Solid Tumor, Protocol Specific
- dermatologic complications
- unspecified adult solid tumor, protocol specific
Name | Location |
|---|---|
| Ingalls Cancer Care Center at Ingalls Memorial Hospital | Harvey, Illinois 60426 |
