Table 3.
Cohort A (non-EIAC), 125 mg/m2 | Cohort B (EIAC), 400 mg/m2 | |||||||
---|---|---|---|---|---|---|---|---|
All patients (n = 15) |
6/6 (n = 5) | 6/7 (n = 8) | 7/7 (n = 2a) |
All patients (n = 12) |
6/6 (n = 3) | 6/7 (n = 7) | 7/7 (n = 2a) |
|
CPT-11 | ||||||||
Cmax (ng/ml) | 1035 ± 272 | 1038 ± 314 | 901 ± 285 | 1318 | 3361 ± 943 | 3837 ± 1001 | 3378 ± 438 | 2589 |
t1/2 (h) | 6.27 ± 2.38 | 7.32 ± 4.26 | 6.05 ± 0.80 | 5.51 | 5.61 ± 0.91 | 5.33 ± 0.16 | 5.52 ± 1.00 | 6.34 |
AUC (ng/ml h) | 6890 ± 2448 | 5458 ± 2030 | 7322 ± 2885 | 9431 | 19449 ± 2966 | 21296 ± 5499 | 18697 ± 1484 | 19170 |
Cl (1/h/m2) | 20.8 ± 8.9 | 26.4 ± 12.1 | 19.0 ± 5.8 | 13.9 | 20.9 ± 2.6 | 19.6 ± 4.8 | 21.5 ± 1.7 | 20.9 |
APC | ||||||||
Cmax (ng/ml) | 104 ± 30 | 112 ± 39 | 101 ± 28 | 92 | 857 ± 312 | 796 ± 324 | 901 ± 336 | 794 |
t1/2 (h) | 6.3 ± 1.5 | 5.7 ± 0.5 | 7.0 ± 1.9 | 5.3 | 6.4 ± 1.7 | 6.4 ± 1.6 | 5.9 ± 1.0 | 8.4 |
AUC (ng/ml h) | 1327 ± 538 | 1063 ± 220 | 1549 ± 656 | 1095 | 10073 ± 3581 | 8466 ± 5095 | 10398 ± 3459 | 11345 |
SN-38 | ||||||||
Cmax (ng/ml) | 15.5 ± 10.0 | 14.9 ± 3.2 | 15.2 ± 13.7 | 18.2 | 20.9 ± 12.3 | 18.7 ± 5.3 | 21.8 ± 15.9 | 21.2 |
t1/2 (h) | 18.8 ± 19.2 | 16.3 ± 5.2 | 21.9 ± 26.4 | 12.7 | 17.3 ± 10.4 | 16.9 ± 4.1 | 14.4 ± 7.4 | 28.0 |
AUC (ng/ml h) | 207 ± 141 | 141 ± 22 | 248 ± 184 | 207 | 212 ± 89 | 180 ± 57 | 203 ± 94 | 291 |
SN-38G | ||||||||
Cmax (ng/ml) | 43.7 ± 22.3 | 56.6 ± 20.4 | 38.6 ± 23.8 | 31.9 | 133 ± 62 | 109 ± 80 | 145 ± 65 | 126 |
t1/2 (h) | 11.7 ± 2.8 | 11.0 ± 2.5 | 12.5 ± 3.2 | 10.4 | 12.7 ± 5.2 | 14.0 ± 3.4 | 11.2 ± 4.9 | 16.0 |
AUC (ng/ml h) | 580 ± 377 | 550 ± 221 | 658 ± 482 | 340 | 1314 ± 604 | 1119 ± 1054 | 1305 ± 487 | 1635 |
Mean value only is listed for 7/7 variant, as n = 2