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


N/A
18 Years
N/A
Open (Enrolling)
Both
Dermatologic Complications, Unspecified Adult Solid Tumor, Protocol Specific

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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 HospitalHarvey, Illinois  60426