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

September 19, 2013 updated by: Ingalls Memorial Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Harvey, Illinois, United States, 60426
        • Recruiting
        • Ingalls Cancer Care Center at Ingalls Memorial Hospital
        • Contact:
          • Clinical Trials Office - Ingalls Cancer Care Center at Ingalls
          • Phone Number: 708-915-4673

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Efficacy of Regenecare® wound gel, in terms of alleviating pain and itching

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ingalls Memorial Hospital

Investigators

  • Study Chair: Mark F. Kozloff, MD, Ingalls Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Study Registration Dates

First Submitted

July 10, 2007

First Submitted That Met QC Criteria

July 10, 2007

First Posted (Estimate)

July 11, 2007

Study Record Updates

Last Update Posted (Estimate)

September 20, 2013

Last Update Submitted That Met QC Criteria

September 19, 2013

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000553120
  • IMH-REG-ING-100
  • MPMM-IMH-REG-ING-100

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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