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.
Primary Outcome Measures:
- Efficacy of Regenecare® wound gel, in terms of alleviating pain and itching
Secondary Outcome Measures:
- Efficacy of Regenecare® wound gel, in terms of reducing severity, redness, and appearance of rash
- Tolerability of Regenecare® wound gel as assessed by NCI CTCAE v3.0
Estimated Enrollment: |
20 |
Study Start Date: |
July 2006 |
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.