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• W904549216 abstract "Proc Amer Assoc Cancer Res, Volume 46, 20053986 Irofulven is a semi-synthetic derivative of the mushroom derived natural product illudin S that has demonstrated preclinical and clinical activity in a variety of tumor types. Pharmacokinetics, metabolism, and routes of excretion of [14C]-irofulven were evaluated in patients with advanced solid tumors. In this Phase I open label study, 3 patients (2 males and 1 female, 48-64 yr) received a dose of 0.55 mg/kg irofulven containing 100 μCi of [14C]-irofulven administered over a 30 min intravenous infusion on Day 1 of Cycle 1. Serial blood, plasma, urine, fecal, saliva, respiratory air, and tear samples were obtained up to 144 hr after the start of infusion. The plasma radioactivity declined with a distribution phase followed by a long elimination and was measurable up to 144 hr. In plasma, parent irofulven represented 0.2% of total radioactivity AUC(0-t). The Cmax (mean±SD) was 1130 ± 174 ng-eq/ml and 82.7±46.0 ng/ml for radioactivity and parent irofulven, respectively and occurred at Tmax of 0.72±0.12 and 0.29±0.1 hr, respectively. AUC(0-∞), CLp, Vdss, and t½ for irofulven were 65.5±2.39 ng•hr/ml, 8.48±0.14 L/hr/kg, 3.12±1.99 L/kg, and 18±6 min, respectively. Blood to plasma AUC(0-t) ratio of radioactivity was 1.6±0.74 indicating little partitioning of irofulven-derived radioactivity into erythrocytes. Urinary excretion (71.2±9.6% of dose) was a major route of elimination of [14C]-irofulven equivalents and 2.9±2.4% of the radioactive dose was recovered in feces. Low levels of radioactivity were measurable in expired air and saliva. Metabolite profiling of urine samples indicated the presence of irofulven and seven metabolic products and two glucuronide conjugates. Plasma radioactivity profiling showed presence of two metabolites, none representing a major metabolite. The safety profile of irofulven was consistent with previous studies. No grade 4 hematotoxicity or biochemical abnormalities occurred. One patient experienced simultaneous grade 4 vomiting and dehydration (one episode of each). These results indicate that irofulven undergoes extensive metabolism and urinary excretion is the principal route of elimination of metabolites from the body." @default.
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• W904549216 date "2005-05-01" @default.
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• W904549216 title "Pharmacokinetics, metabolism, and routes of excretion of intravenous [14C]-irofulven in patients with advanced solid tumors" @default.
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