Table 5.
Timings for PK collection
Edotecarin PK | Pre-edotecarin infusion | During edotecarin infusion | Post-end edotecarin infusion |
---|---|---|---|
Cycle 1 (12 samples) | Within 30 min before start of infusion | 15, 30 and 50 min after start of infusion | 5, 15, 30 min and 1, 1.25, 1.5, 2, 3, 4, 6, 8, 24, 48, 72 and 96 h |
Cycle 2 (10 samples) | Within 30 min before start of infusion | 50min after start of infusion | 5min and 1, 2, 4, 24, 48, and 72 h |
5-FU PK | During 5-FU infusion | Post-end 5-FU infusion | |
Cycle 1 (5 samples) | 3 h, 24 h, and 45 h+ 50 min, after start of infusion | 10 min and 1 h | |
Cycle 2 (5 samples) | 3 h, 24 h, and 45 h+ 50 min, after start of infusion | 10 min and 1 h |
5-FU, 5-fluorouracil; PK, pharmacokinetics.
Each blood sample was placed on ice immediately after collection and, within 60 min for edotecarin samples and 30 min for 5-FU samples, centrifuged for harvesting of plasma. Centrifugation was done either at room temperature or at 4°C. Plasma was stored frozen (at or below −20°C).