A Phase I, Single-centre, Non-randomized, Open-label Study to Determine the Lowest Effective Theophylline Dose That Decreased Erlotinib's Diarrhea at the Standard Dose of 150 mg/Day and to Determine the Highest Erlotinib Dose in Combination With Theophylline That Can be Administered to Patients
This study is to determine the use of theophylline in patients with NSCLC and advanced solid
malignancies and whether treatment with theophylline will help lower or diminish the side
effect of diarrhea in patients taking erlotinib. Patients will be enrolled in one of two
parts of the study to verify the lowest dose of theophylline that is effective and the
highest dose of erlotinib that can be tolerated with theophylline. If this study shows that
theophylline is able to inhibit erlotinib induced diarrhea, it will help demonstrate that
patients using the tyrosine kinase inhibitor (TKIs), erlotinib, can use it effectively at
higher doses without experiencing severe diarrhea.
View this trial on ClinicalTrials.gov
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