Table 4b. Mean (s.d.) pharmacokinetic parameters of gemcitabine, dFdU and dFdCTP with or without tipifarnib (100–300 mg).
Variable | Units | Gem/cis (s.d.) n=23 | Gem/cis+tipifarnib (s.d.) n=29 | P-valuea |
---|---|---|---|---|
Plasma gemcitabine | ||||
Median tmax | Hours | 0.50 | 0.50 | — |
Cmaxb | μg ml−1 | 12.5 (3.53) | 12.6 (2.31) | 0.197c |
AUC0–48b | h μg ml−1 | 6.71 (2.12)d | 6.67 (1.07)e | 0.200f |
t1/2 | Hours | 0.18 (0.06)d | 0.55 (1.77)g | — |
Plasma dFdU | ||||
Median tmax | Hours | 0.6g | 0.61h | — |
Cmaxb | μg ml−1 | 25.6 (5.47)g | 27.0 (4.89)h | 0.028g |
AUC0–48b | h μg ml−1 | 237 (89.4)d | 274 (119)e | 0.032f |
t1/2 | Hours | 32.4 (26.2)g | 10.2 (6.37)h | — |
Mononuclear blood cell dFdCTP | ||||
AUC0–24b | h nanomol mg protein−1 | 18.3 (40.9)i | 14.7 (22.9)j | 0.303d |
Two-sided P-value for testing a difference between the two treatments. Only data from patients who completed the study were included.
Parameter values adjusted to 750 mg m−2 dose of gemcitabine.
n=22.
n=19.
n=20.
n=14.
n=24.
n=30.
n=21.
n=26.
Gem=gemcitabine; cis=cisplatin.