Topical Sunscreen 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.

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