Regenecare® Wound Gel in Treating Rash in Patients Receiving Cetuximab or Other Epidermal Growth Factor Receptor Inhibitor Therapy for Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Regenecare® in the Treatment of Skin Rash Associated With Cetuximab (Erbitux®) or Other EGFR Treated Cancer Patients

Conditions
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Dermatologic Complications, Unspecified Adult Solid Tumor, Protocol Specific

Intervention / Treatment
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* Dietary Supplement: collagen/aloe vera/vitamin E/lidocaine topical hydrogel


Participation Criteria
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Eligibility 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care


Arms and Interventions

| Intervention/Treatment |
| --- |
|Dietary Supplement: collagen/aloe vera/vitamin E/lidocaine topical hydrogel|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of Regenecare® wound gel, in terms of alleviating pain and itching |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dermatologic complications, unspecified adult solid tumor, protocol specific