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Completed

NCT Number: NCT00362986

Topical Sunscreen in Preventing Skin Rash in Patients Receiving Drugs Such as Erlotinib or Cetuximab for Cancer

RATIONALE: Topical sunscreen may be effective in preventing skin rash caused by treatment with drugs such as erlotinib or cetuximab. It is not yet known whether topical sunscreen is more effective than a placebo in preventing skin rash in patients receiving drugs such as erlotinib or cetuximab for cancer.

PURPOSE: This randomized phase III trial is studying topical sunscreen to see how well it works compared with a placebo in preventing skin rash in patients receiving drugs such as erlotinib or cetuximab for cancer.

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Key information

Conditions

Dermatologic Complications Unspecified Adult Solid Tumor, Protocol Specific

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Mayo Clinic - Jacksonville, Jacksonville, Florida, United States

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About this study

OBJECTIVES:

  • Compare the incidence and severity of erlotinib-, cetuximab-, or other epidermal growth factor receptor inhibitor-induced skin rash development in patients with cancer treated with prophylactic topical sunscreen vs placebo.
  • Determine the toxicity of topical sunscreen vs placebo in these patients.
  • Determine whether discontinuation of treatment intervention is followed by rash development.

OUTLINE: This is a multicenter, randomized, double-blind, placebo-controlled study. Patients are stratified according to chemotherapy regimen (first-line chemotherapy vs other), epidermal growth factor receptor (EGFR) inhibitor therapy (small molecule vs monoclonal antibodies), concurrent medication that increases sun hypersensitivity (yes vs no), and gender. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients apply sunscreen generously to the entire body twice daily for 4 weeks.
  • Arm I: Patients apply placebo generously to the entire body twice daily for 4 weeks.

Patients complete self-reported questionnaires regarding their rash status at baseline and then weekly for 8 weeks.

After completion of study treatment, patients are followed for 8 weeks.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

DISEASE CHARACTERISTICS:

  • Diagnosis of cancer
  • Receiving ≥ 1 of the following epidermal growth factor receptor (EGFR) inhibitor treatments:
  • Gefitinib
  • Cetuximab
  • Erlotinib
  • Panitumumab
  • ICR-62
  • Matuzumab
  • CI-1033
  • EGFR treatment must have begun within the past 3 days
  • No rash (of any etiology) at study entry

PATIENT CHARACTERISTICS:

  • Able to apply sunscreen on face, trunk, and extremities
  • Able to complete questionnaire(s)
  • No history of allergic reactions or severe intolerance to sunscreen or its derivatives
  • No history of skin problems likely to reoccur during treatment
  • Must avoid heavy sun exposure, especially during the hours of noon to 4 pm daily

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No concurrent tanning bed usage
  • No other concurrent topical sunscreens

Treatment and study plan

Sunscreen

Drug

Placebo

Other

Primary outcomes

  1. Incidence and severity of rash development by Skindex questionnaire

    Time frame: Up to 8 weeks

Secondary outcomes

  1. Toxicity by NCI CTCAE v3.0

    Time frame: Up to 8 weeks

  2. Rash incidence at 4 and 8 weeks

    Time frame: Up to 8 weeks

Sponsors and collaborators

Lead sponsor

Alliance for Clinical Trials in Oncology

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

A Phase III, Randomized, Double-Blind, Placebo-Controlled Trial of Prophylactic Topical Sunscreen to Prevent Erlotinib- or Cetuximab-Induced Skin Rash [or Other Epidermal Growth Factor Receptor (EGFR) Inhibitor-Induced Skin Rash]

Important dates

Study start
2006
Primary completion
2007
Study completion
2009
First posted
Aug 15, 2006
Registry last updated
Dec 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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