Table 1.
Dose escalation and extent of drug exposure.
| Daily × 5 q 2 weeks schedule (n = 8) | |||||
|---|---|---|---|---|---|
| Dose Level | Triapine Dose (mg/m2/day) | Cisplatin Dose (mg/m2 )* | No. of new patients | Total no. of patients treated╤ | Total no. course administered |
| −1b | 84 | 20 | 0 | 2 | 2 |
| −1a | 84 | 25 | 0 | 2 | 8 |
| 1 | 96 | 25 | 5 | 5 | 9 |
| 2 | 96 | 37.5 | 3 | 3 | 6 |
| Daily × 5 q 3 weeks schedule (n = 2) | |||||
| Dose Level | Triapine Dose (mg/m2/day) | Cisplatin Dose (mg/m2 )** | No. of new patients | Total no. of patients treated╤ | Total no. course administered |
| −1 | 84 | 37.5 | 0 | 1 | 3 |
| 1 | 96 | 25 | 0 | 1 | 1 |
| 2 | 96 | 37.5 | 2 | 3 | 5 |
| Daily × 4 q 3 weeks schedule (n = 15) | |||||
| Dose Level | Triapine Dose (mg/m2/day) | Cisplatin Dose (mg/m2 )*** | No. of new patients | Total no. of patients treated╤ | Total no. course administered |
| −2 | 48 | 40 | 0 | 1 | 1 |
| −1b | 72 | 50 | 0 | 1 | 1 |
| −1a | 72 | 75 | 0 | 3 | 9 |
| 1 | 96 | 50 | 5 | 5 | 24 |
| 2 | 96 | 75 | 10† | 10 | 26 |
╤
Some patients were treated at more than one dose level.
*
Cisplatin dose administered on day 3.
**
Cisplatin dose divided over day 3 and day 4.
***
Cisplatin dose divided over day 2 and day 3.
†
Seven of 10 patients at cycle 1 consented to treatment by a single dose of oral triapine.