A Pilot Cross-Over Study to Evaluate the Use of Regenecare™ Topical Gel in Patients With Cutaneous Toxicity Caused by Epidermal Growth Factor Receptor (HER1/EGFR) Inhibitors
18 Years
N/A
Both
Dermatologic Complications, Unspecified Adult Solid Tumor, Protocol Specific
Trial Information
A Pilot Cross-Over Study to Evaluate the Use of Regenecare™ Topical Gel in Patients With Cutaneous Toxicity Caused by Epidermal Growth Factor Receptor (HER1/EGFR) Inhibitors
OBJECTIVES:
Primary
- Determine the efficacy of Regenecare® wound gel in alleviating pain and itching in
patients who develop an acneform rash while undergoing treatment with human epidermal
receptor 1 (HER1)/epidermal growth factor receptor (EGFR) inhibitor therapy for cancer.
Secondary
- Determine the tolerability of this drug in these patients.
- Determine satisfaction of these patients with this drug.
OUTLINE: This is a pilot, prospective, study.
- Observation: Patients undergo facial evaluation by full-face photography (i.e., camera
lens 12-18 inches from the face) prior to development of skin rash (baseline). Patients
then self-monitor for the appearance of acneform skin rash while undergoing concurrent
cancer therapy. Upon initial onset of rash, patients are re-evaluated. Patients with
grade 2 skin rash proceed to treatment.
- Treatment: Patients apply topical Regenecare® wound gel to the right side of the face ≥
4 times daily. After 1 week of treatment, patients apply the gel to both sides of the
face. Treatment continues for ≥ 6 weeks in the absence of unacceptable toxicity or
until the rash disappears.
Patients are evaluated weekly by facial examination, full-face photography, clinical
symptoms self-reported in a patient diary, and questionnaires measuring patient satisfaction
and quality of life.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Diagnosis of cancer
- Concurrently receiving or expected to receive human epidermal receptor 1
(HER1)/epidermal growth factor receptor (EGFR) inhibitor therapy on another study
- No other serious concurrent skin disorders (i.e., scleroderma or psoriasis) that
would interfere with assessment of EGFR inhibitor-induced rash
PATIENT CHARACTERISTICS:
- Not pregnant or nursing
- No known history of hypersensitivity to local anesthetics of the amine type or to
other components of Regenecare® wound gel
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No concurrent medications that can cause skin rash
Type of Study:
Interventional
Study Design:
Primary Purpose: Supportive Care
Outcome Measure:
Severity, in terms of pain and itching, as assessed by NCI CTCAE v3.0
Principal Investigator
Siu-Fun Wong
Investigator Role:
Study Chair
Investigator Affiliation:
Western University of Health Sciences
Authority:
United States: Federal Government
Study ID:
CDR0000542427
NCT ID:
NCT00466427
Start Date:
April 2006
Completion Date:
Related Keywords:
- Dermatologic Complications
- Unspecified Adult Solid Tumor, Protocol Specific
- dermatologic complications
- unspecified adult solid tumor, protocol specific
Name | Location |
|---|---|
| St. Joseph Hospital Regional Cancer Center - Orange | Orange, California 92868-3849 |
| Hematology Oncology Medical Group of Orange County, Incorporated | Orange, California 92868 |
| Western University of Health Sciences | Pomona, California 91766 |
