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 (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00362986
First received: August 10, 2006
Last updated: July 7, 2015
Last verified: July 2015

August 10, 2006
July 7, 2015
October 2006
October 2009   (final data collection date for primary outcome measure)
Incidence and severity of rash development by Skindex questionnaire [ Time Frame: Up to 8 weeks ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00362986 on ClinicalTrials.gov Archive Site
  • Toxicity by NCI CTCAE v3.0 [ Time Frame: Up to 8 weeks ] [ Designated as safety issue: Yes ]
  • Rash incidence at 4 and 8 weeks [ Time Frame: Up to 8 weeks ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
Not Provided
 
Topical Sunscreen in Preventing Skin Rash in Patients Receiving Drugs Such as Erlotinib or Cetuximab for Cancer
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]

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.

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.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
  • Dermatologic Complications
  • Unspecified Adult Solid Tumor, Protocol Specific
  • Drug: sunscreen
  • Other: placebo
  • Experimental: sunscreen

    Patients apply sunscreen 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.

    Intervention: Drug: sunscreen
  • Placebo Comparator: placebo

    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.

    Intervention: Other: placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
116
October 2009
October 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00362986
NCCTG-N05C4, NCI-2012-02700, CDR0000492254
No
Alliance for Clinical Trials in Oncology
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Study Chair: Aminah Jatoi, MD Mayo Clinic
Alliance for Clinical Trials in Oncology
July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP