IRINOTECAN IN REFRACTORY SOLID TUMOR PATIENTS W HEPATIC

$0M01FY2001RRNIH

Mayo Clinic Coll Of Medicine, Rochester, Rochester MN

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Abstract

Our hypothesis is that Irinotecan (CPT-11) is a potent and effective antitumor agent in refractory solid tumor patients with hepatic dysfunction. The specific aims of this study are to determine the initial maximum tolerated dose (MTD) of CPT-11 when administered to patients with varying degrees of hepatic dysfunction; to ascertain the pharmacokinetics/pharmacodynamics of CPT-11 and its metabolites (SN-38 and SN-38 glucuronide) in patients with refractory solid tumors and hepatic dysfunction; to evaluate the qualitative and quantitative toxicities of CPT-11 in this patient population; and to assess the antitumor activity of CPT-11 in this patient population.

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