Table 3.
Toxicities per dose level (2-dose schedule)
Level | N | Gem infusion (min) | Gem dose (mg/m2) | Mucositis | Skin | DLT | ||
---|---|---|---|---|---|---|---|---|
G2 | G3 | G2 | G3 | |||||
1 | 3 | 15 | 225 | 33% | 0 | 0 | 0 | 0% |
2 | 3 | 40 | 475 | 0 | 0 | 0 | 0 | 0% |
3 | 3 | 60 | 675 | 33% | 0 | 0 | 0 | 0% |
4 | 6 | 90 | 975 | 80% | 0 | 0 | 0 | 0% |
5 | 14 | 120 | 1,275 | 59% | 23% | 12% | 0 | 6% |
6 | 22 | 180 | 1,875 | 71% | 6% | 18% | 0 | 2% |
7 | 14 | 210 | 2,175 | 60% | 27% | 33% | 0 | 7% |
8 | 14 | 240 | 2,475 | 64% | 28% | 21% | 7% | 7% |
9 (MTD) | 50 | 270 | 2,775 | 54% | 28% | 18% | 3% | 14% |