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

Ingalls Memorial Hospital

Status: Unknown

Conditions: Unspecified Adult Solid Tumor, Protocol Specific; Dermatologic Complications

Treatments: Dietary Supplement: collagen/aloe vera/vitamin E/lidocaine topical hydrogel

Study type: Interventional

Funder types: Other

Identifiers

NCT00498992

CDR0000553120

IMH-REG-ING-100

MPMM-IMH-REG-ING-100

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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