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

NCT00498992 | Unknown

• 3 other identifiers: CDR0000553120IMH-REG-ING-100MPMM-IMH-REG-ING-100
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Dermatologic Complications; Unspecified Adult Solid Tumor, Protocol Specific

Keywords

dermatologic complications; unspecified adult solid tumor, protocol specific

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (2)

• 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

Interventions

collagen/aloe vera/vitamin E/lidocaine topical hydrogel DIETARY_SUPPLEMENT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Ingalls Memorial Hospital: lead

Study Sites (1)

Ingalls Cancer Care Center at Ingalls Memorial Hospital

Harvey, Illinois, 60426, United States

RECRUITING

Study Officials

• Mark F. Kozloff, MD

  Ingalls Memorial Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Purpose: SUPPORTIVE CARE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 10, 2007
• First Posted: July 11, 2007
• Study Start: July 1, 2006
• Last Updated: September 20, 2013

Record last verified: 2009-07

Locations

US (1)