Clinical trial NCT00498992: Regenecare® Wound Gel in Treating Rash in Patients Receiving Cetuximab or Other Epidermal Growth Factor Receptor Inhibitor Therapy for Cancer
Official title: Regenecare® in the Treatment of Skin Rash Associated With Cetuximab (Erbitux®) or Other EGFR Treated Cancer Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dermatologic Complications
Unspecified Adult Solid Tumor, Protocol Specific
Keywords: dermatologic complications
unspecified adult solid tumor, protocol specific
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2007-07-11
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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 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

Primary outcomes:
measure: Efficacy of Regenecare® wound gel, in terms of alleviating pain and itching
Secondary outcomes:
measure: Efficacy of Regenecare® wound gel, in terms of reducing severity, redness, and appearance of rash
measure: Tolerability of Regenecare® wound gel as assessed by NCI CTCAE v3.0
Other outcomes:
Locations:
city: Harvey
country: United States
facility: Ingalls Cancer Care Center at Ingalls Memorial Hospital
state: Illinois
Study officials:
affiliation: Ingalls Memorial Hospital
name: Mark F. Kozloff, MD
role: STUDY_CHAIR
References: