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

Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00498992
• Other study ID #: CDR0000553120
• Secondary ID: IMH-REG-ING-100M
• Status: Recruiting
• Phase: N/A
• First received: July 10, 2007
• Last updated: September 19, 2013
• Start date: July 2006

Study information

• Verified date: July 2009
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Dermatologic Complications
• Unspecified Adult Solid Tumor, Protocol Specific

Intervention

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

Locations

Country	Name	City	State
United States	Ingalls Cancer Care Center at Ingalls Memorial Hospital	Harvey	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Ingalls Memorial Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of Regenecare® wound gel, in terms of alleviating pain and itching
Secondary	Efficacy of Regenecare® wound gel, in terms of reducing severity, redness, and appearance of rash
Secondary	Tolerability of Regenecare® wound gel as assessed by NCI CTCAE v3.0