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

Alliance for Clinical Trials in Oncology

Status and phase: Completed; Phase 3

Conditions: Unspecified Adult Solid Tumor, Protocol Specific; Dermatologic Complications

Treatments: Other: placebo; Drug: sunscreen

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00362986

NCI-2012-02700 (Registry Identifier)

CDR0000492254 (Registry Identifier)

NCCTG-N05C4

Details and patient eligibility

About

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.

Full 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.

Enrollment: 116 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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116 participants in 2 patient groups, including a placebo group

sunscreen

Experimental group

Description:

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.

Treatment:

Drug: sunscreen

placebo

Placebo Comparator group

Description:

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.

Treatment:

Other: placebo