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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00498992
First received: July 10, 2007
Last updated: September 19, 2013
Last verified: July 2009
  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
Dietary Supplement: collagen/aloe vera/vitamin E/lidocaine topical hydrogel

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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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    708-915-4673      
Sponsors and Collaborators
Ingalls Memorial Hospital
Investigators
Study Chair: Mark F. Kozloff, MD Ingalls Memorial Hospital
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00498992     History of Changes
Other Study ID Numbers: CDR0000553120, IMH-REG-ING-100, MPMM-IMH-REG-ING-100
Study First Received: July 10, 2007
Last Updated: September 19, 2013
Health Authority: Unspecified

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

Additional relevant MeSH terms:
Lidocaine
Vitamin E
Vitamins
Cetuximab
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Antioxidants
Protective Agents
Micronutrients
Growth Substances
Antineoplastic Agents

ClinicalTrials.gov processed this record on August 01, 2014