Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information
Regenecare® Wound Gel in Treating Rash in Patients Receiving Cetuximab or Other Epidermal Growth Factor Receptor Inhibitor Therapy for Cancer
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| No phase specified | Supportive care | Active | 18 and over | Other, Pharmaceutical / Industry | IMH-REG-ING-100 REG ING 100, MPMM-IMH-REG-ING-100, NCT00498992 |
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.
Entry Criteria
Disease Characteristics:
- Diagnosis of cancer
- Starting treatment with cetuximab or other EGFR inhibitor (e.g., erlotinib hydrochloride) on another clinical trial
Prior/Concurrent Therapy:
- See Disease Characteristics
- No other concurrent topical facial creams or lotions
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
Expected Enrollment
20Outcomes
Primary Outcome(s)Efficacy of Regenecare® wound gel, in terms of alleviating pain and itching
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
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.
Trial Lead Organizations
Ingalls Cancer Care Center at Ingalls Memorial Hospital
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| Mark Kozloff, MD, Protocol chair | |
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| Ingalls Cancer Care Center at Ingalls Memorial Hospital | |||||||
| Clinical Trials Office - Ingalls Cancer Care Center at Ingalls Memorial Hospital |
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| Registry Information | ||
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| Official Title | Regenecare® in the Treatment of Skin Rash Associated with Cetuximab (Erbitux®) or Other EGFR Treated Cancer Patients | |
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| Trial Start Date | 2006-07-28 | |
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| Registered in ClinicalTrials.gov | NCT00498992 | |
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| Date Submitted to PDQ | 2007-05-24 | |
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| Information Last Verified | 2009-07-05 | |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.
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