Topical Sunscreen in Preventing Skin Rash in Patients Receiving Drugs Such as Erlotinib or Cetuximab for Cancer
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.
Unspecified Adult Solid Tumor, Protocol Specific
Drug: canertinib dihydrochloride
Drug: erlotinib hydrochloride
Drug: titanium dioxide/zinc oxide sunscreen cream SPF 60
|Study Design:||Allocation: Randomized
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]|
- Incidence and severity of rash development by Skindex questionnaire
- Toxicity by NCI CTCAE v3.0
- Rash incidence at 4 and 8 weeks
|Study Start Date:||October 2006|
|Primary Completion Date:||October 2009 (Final data collection date for primary outcome measure)|
- 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.
PROJECTED ACCRUAL: A total of 110 patients will be accrued for this study.
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|Study Chair:||Aminah Jatoi, MD||Mayo Clinic|
|Investigator:||Abby R. Thrower, MD, PhD||Cedar Rapids Oncology Associates|