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

This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), December 2007

Sponsored by: Ingalls Cancer Care Center at Ingalls Memorial Hospital
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00498992
  Purpose

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.


Condition Intervention
Dermatologic Complications
Unspecified Adult Solid Tumor, Protocol Specific
Drug: collagen/aloe vera/vitamin E/lidocaine topical hydrogel
Procedure: observation
Procedure: questionnaire administration

MedlinePlus related topics:   Cancer    Rashes   

ChemIDplus related topics:   Vitamin E    alpha-Tocopherol    alpha-Tocopheryl acetate    Tocopherols    Cetuximab    Epidermal Growth Factor    Lidocaine    Aloe vera   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Supportive Care
Official Title:   Regenecare® in the Treatment of Skin Rash Associated With Cetuximab (Erbitux®) or Other EGFR Treated Cancer Patients

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Efficacy of Regenecare® wound gel, in terms of alleviating pain and itching

Secondary Outcome Measures:
  • 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

Estimated Enrollment:   20
Study Start Date:   July 2006

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00498992

Locations
United States, Illinois
Ingalls Cancer Care Center at Ingalls Memorial Hospital     Recruiting
      Harvey, Illinois, United States, 60426
      Contact: Clinical Trials Office - Ingalls Cancer Care Center at Ingalls     708-915-6747        

Sponsors and Collaborators
Ingalls Cancer Care Center at Ingalls Memorial Hospital

Investigators
Study Chair:     Mark F. Kozloff, MD     Ingalls Cancer Care Center at Ingalls Memorial Hospital    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000553120, IMH-REG-ING-100, MPMM-IMH-REG-ING-100
First Received:   July 10, 2007
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00498992
Health Authority:   Unspecified

Keywords provided by National Cancer Institute (NCI):
dermatologic complications  
unspecified adult solid tumor, protocol specific  

Study placed in the following topic categories:
Tocopherols
Exanthema
Tocopherol acetate
Vitamin E
Cetuximab
Lidocaine
Alpha-Tocopherol

ClinicalTrials.gov processed this record on October 06, 2008




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