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
  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
Drug: sunscreen
Other: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
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 Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:
  • Incidence and severity of rash development by Skindex questionnaire [ Time Frame: Up to 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 116
Study Start Date: October 2006
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

Other: placebo

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.

  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
Alliance for Clinical Trials in Oncology
Investigators
Study Chair: Aminah Jatoi, MD Mayo Clinic
  More Information

Additional Information:
Publications:
Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00362986     History of Changes
Other Study ID Numbers: NCCTG-N05C4, NCI-2012-02700, CDR0000492254
Study First Received: August 10, 2006
Last Updated: July 7, 2015
Health Authority: United States: Federal Government

Keywords provided by Alliance for Clinical Trials in Oncology:
dermatologic complications
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Sunscreening Agents
Dermatologic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Radiation-Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 30, 2015