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Single doses of XELODA were not lethal to miceratsand monkeys at doses up to 2000 mg/kg2.44.8and 9.6 times the recommended human daily dose on a mg/m 2 basis
Table 4 shows the adverse reactions occurring in5of patients from one phase 3 trial in patients with DukesC colon cancer who received at least one dose of study medication and had at least one safety assessmentA total of 995 patients were treated with 1250 mg/m 2 twice a day of XELODA administered for 2 weeks followed by a 1-week rest periodand 974 patients were administered 5-FU and leucovorin20 mg/m 2 leucovorin IV followed by 425 mg/m 2 IV bolus 5-FU on days 1-5 every 28 daysThe median duration of treatment was 164 days for capecitabine-treated patients and 145 days for 5-FU/LV-treated patientsA total of 11211and 737capecitabine and 5-FU/LV-treated patientsrespectivelydiscontinued treatment because of adverse reactionsA total of 18 deaths due to all causes occurred either on study or within 28 days of receiving study drug80.8patients randomized to XELODA and 101.0randomized to 5-FU/LV.
Following oral administration of 825 mg/m 2 capecitabine twice daily for 14 daysJapanese patientsn=18had about 36lower Cmax and 24lower AUC for capecitabine than the Caucasian patientsn=22Japanese patients had also about 25lower Cmax and 34lower AUC for FBAL than the Caucasian patientsThe clinical significance of these differences is unknownNo significant differences occurred in the exposure to other metabolites5DFCR5DFURand 5-FU
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