Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial
Official title:
An Exploratory, Placebo-Controlled Trial of Prophylactic Tetracycline for Gefitinib-or Cetuximab-Induced Skin Rash (or Other Epidermal Growth Factor Receptor (EGFR) Inhibitor-Induced Skin Rash)
RATIONALE: Tetracycline may be effective in preventing skin rash that is caused by treatment
with drugs such as gefitinib or cetuximab.
PURPOSE: This randomized clinical trial is studying tetracycline to see how well it works
compared to placebo in preventing skin rash in patients who are receiving drugs such as
gefitinib or cetuximab for cancer.
OBJECTIVES:
- Compare the 1-month incidence and severity of gefitinib-, cetuximab-, or other
epidermal growth factor receptor inhibitor-induced skin rash development in patients
with cancer treated with tetracycline vs placebo.
- Compare the toxicity of these drugs in these patients.
- Compare the quality of life of patients treated with these drugs who develop vs those
who do not develop a rash.
- Determine whether patients who discontinue tetracycline at 1 month develop a rash.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients
are stratified according to prior chemotherapy regimen (first-line therapy vs other),
concurrent epidermal growth factor receptor inhibitor therapy (gefitinib vs cetuximab vs
other), and concurrent corticosteroid therapy (yes vs no). Patients are randomized to 1 of 2
treatment arms.
- Arm I: Patients receive oral tetracycline twice daily.
- Arm II: Patients receive oral placebo twice daily. In both arms, treatment continues
for 4 weeks in the absence of unacceptable toxicity.
Quality of life is assessed at baseline and then weekly for 8 weeks.
Patients are followed at weeks 4 and 8.
PROJECTED ACCRUAL: A total of 126 patients will be accrued for this study.
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