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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00362986
First received: August 10, 2006
Last updated: September 20, 2011
Last verified: October 2009
  Purpose

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.


Condition Intervention Phase
Dermatologic Complications
Unspecified Adult Solid Tumor, Protocol Specific
Biological: cetuximab
Biological: matuzumab
Biological: panitumumab
Drug: canertinib dihydrochloride
Drug: erlotinib hydrochloride
Drug: gefitinib
Drug: titanium dioxide/zinc oxide sunscreen cream SPF 60
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Supportive Care
Official 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]

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Incidence and severity of rash development by Skindex questionnaire

Secondary Outcome Measures:
  • Toxicity by NCI CTCAE v3.0
  • Rash incidence at 4 and 8 weeks

Estimated Enrollment: 110
Study Start Date: October 2006
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Detailed Description:

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.

PROJECTED ACCRUAL: A total of 110 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00362986

  Show 208 Study Locations
Sponsors and Collaborators
North Central Cancer Treatment Group
Investigators
Study Chair: Aminah Jatoi, MD Mayo Clinic
Investigator: Abby R. Thrower, MD, PhD Cedar Rapids Oncology Associates
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00362986     History of Changes
Other Study ID Numbers: CDR0000492254, NCCTG-N05C4
Study First Received: August 10, 2006
Last Updated: September 20, 2011
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Exanthema
Skin Diseases
Sunscreening Agents
Zinc Oxide
Titanium dioxide
CI 980
Gefitinib
Cetuximab
Erlotinib
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dermatologic Agents
Therapeutic Uses
Photosensitizing Agents
Radiation-Sensitizing Agents
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Cardiotonic Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on July 26, 2014