Caponigro F et al. - In a study to find the maximum tolerated dose and assess toxicity and activity of gefitinib administered along with standard radiation therapy, it was found that results do not support further trials with gefitinib and radiation therapy in this patient population Methods
2 different doses of gefitinib, administered with standard radiation therapy, were tested in locally advanced inoperable head and neck cancer
The standard '3+3' design was used for the phase I study
Radiation therapy was given according to conventional dose and schedule
Gefitinib dose escalation was stopped if more than one-third of pts of a given cohort had dose-limiting toxicity
Results
Dose-limiting toxicity was observed in 3 of 4 pts treated at the dose of 500 mg, and included grade 3 stomatitis in 3 pts and grade 3 liver toxicities in 1 pt
Dose level of 250 mg was recommended for the phase II study
6 confirmed objective responses were observed among 16 pts
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