Table 6.
Demographic and baseline characteristics
| Demographic/baseline variable | Number of patients |
|
|---|---|---|
| Edotecarin +5-FU/LV N=8a |
Edotecarin + 5-FU (w/bolus)/LV N=6b |
|
| Sex | ||
| Male | 7 | 3 |
| Female | 1 | 3 |
| Race | ||
| White | 3 | 2 |
| Black | 0 | 1 |
| Not allowed to ask | 5 | 3 |
| ECOG performance status | ||
| 0 | 4 | 4 |
| 1 | 4 | 2 |
| Age (years) | ||
| Mean (SD) | 60.25 (8.84) | 51 (8.39) |
| Range | 48–73 | 38–61 |
| Weight (kg) | ||
| Mean (SD) | 82.21 (12.95) | 69.13 (14.31) |
| Range | 61–99 | 57–90 |
| Body surface area (ratio) | ||
| Mean (SD) | 1.965 (0.179) | 1.8.01 (0.175) |
| Range | 1.631–2.173 | 1.616–2.017 |
5-FU, 5-fluorouracil; ECOG, Eastern Cooperative Oncology Group; LV, leucovorin; SD, standard deviation.
a
5 patients assigned to edotecarin dose of 6 mg/m2, 3 patients assigned to edotecarin dose of 8 mg/m2.
b
Edotecarin 6 mg/m2, 5-FU administered as bolus and infusion.