Dermatologic Complications, Unspecified Adult Solid Tumor, Protocol Specific
Conditions
Keywords
dermatologic complications, unspecified adult solid tumor, protocol specific
Brief summary
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
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.
Interventions
DRUGsunscreen
OTHERplacebo
Sponsors
National Cancer Institute (NCI)
Alliance for Clinical Trials in Oncology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and severity of rash development by Skindex questionnaire | Up to 8 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Toxicity by NCI CTCAE v3.0 | Up to 8 weeks |
| Rash incidence at 4 and 8 weeks | Up to 8 weeks |
Countries
United States
Outcome results
None listed