Table 6

Summary of mean ± SD CPT-11, SN-38, and SN-38G pharmacokinetic parameters

Dose (mg/m2)
240 (n = 3)290 (n = 12)320 (n = 13)340 (n = 6)
CPT-11
t1/2 (h)12.9 ± 3.612.8 ± 1.811.9 ± 1.712.2 ± 1.6
Cmax (ng/ml)2810 ± 3143418 ± 9753432 ± 5873392 ± 874
AUC (ng/ml·h)18091 ± 165722270 ± 588222695 ± 854622998 ± 7336
CL (liters/h/m2)11.6 ± 1.012.1 ± 3.813.6 ± 4.312.1 ± 3.8
Vz (liters/m2)215 ± 60229 ± 91240 ± 95229 ± 91
Vss (liters/m2)120 ± 13122 ± 52122 ± 35122 ± 52
SN-38
Tmax (h)a1.55 ± 0.051.84 ± 0.722.15 ± 0.832.02 ± 0.40
Cmax (ng/ml)41 ± 268 ± 4068 ± 2756 ± 28
AUC (ng/ml·h)638 ± 124797 ± 405712 ± 276714 ± 415
t1/2 (h)27.1 ± 12.521.5 ± 5.719.3 ± 7.021.0 ± 8.2
SN-38G
Tmax (h)a1.83 ± 0.142.07 ± 0.402.37 ± 0.611.84 ± 0.35
Cmax (ng/ml)109 ± 30160 ± 61198 ± 81168 ± 69
AUC (ng/ml·h)1710 ± 4652421 ± 13472663 ± 14132329 ± 1199
t1/2z (h)20.3 ± 3.819.7 ± 7.017.0 ± 4.517.2 ± 3.6
AUC ratiosb
SN-38/CPT-115.0 ± 0.55.2 ± 2.24.8 ± 2.14.3 ± 1.8
SN-38G/CPT-1113.7 ± 4.615.4 ± 7.216.8 ± 8.414.1 ± 4.9
  • a Time relative to the start of the infusion.

  • b Ratio of SN-38 or SN-38G to CPT-11 AUC, expressed as a percentage.