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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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]

Conditions
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Dermatologic Complications, Unspecified Adult Solid Tumor, Protocol Specific

Intervention / Treatment
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* Drug: sunscreen
* Other: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: sunscreen<br>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<br> <br> |
| Placebo Comparator: placebo<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and severity of rash development by Skindex questionnaire |  | Up to 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity by NCI CTCAE v3.0 |  | Up to 8 weeks | 
| Rash incidence at 4 and 8 weeks |  | Up to 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dermatologic complications, unspecified adult solid tumor, protocol specific