Abstract
8521 Background: Gefitinib (Iressa), an oral Epidermal Growth Factor receptor (EGFR) inhibitor that has been well tolerated in adults, modulates intracellular drug effects through inhibition of efflux pumps (e.g., BCRP). In xenograft models of pediatric solid tumors it has additive/synergistic activity with IRN, which was independent of EGFR status. We are conducting a Phase I study of this combination in children with refractory solid tumors. Methods: Our objectives are to estimate the maximum tolerated dose and dose-limiting toxicities (DLT) of gefitinib administered daily × 21 days in combination with protracted intravenous IRN [day 1- 5, day 8 - 12]. Pharmacokinetic (PK) studies of IRN and metabolites were obtained with and without concurrent gefitinib. PK studies of gefitinib were obtained on days –1 and 8. Courses are repeated every 21 days in the absence of DLT or disease progression. Results: At present, 2 cohorts have been evaluated (age 3 –15 yrs, median 5 yrs). Cohort 1 (n = 5) received continu...
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