Table 3.
Dose-limiting toxicities
| Sunitinib dose (mg) | Pemetrexed dose (mg/m2) | Carboplatin dose (AUC mg·min/ml) | n | DLT detailsa |
|---|---|---|---|---|
| Schedule 2/1 (n = 21) | ||||
| 37.5 | 400 | 5 | 3 | – |
| 37.5b | 500b | 5b | 6 | Grade 3 neutropenia (n = 1) |
| 50 | 500 | 5 | 6 |
Grade 3 thrombocytopenia (n = 1) Grade 4 neutropenia (n = 2) |
| CDD schedule (n = 3) | ||||
| 37.5 | 400 | 5 | 3 |
Grade 3 hand–foot syndrome (n = 1) Grade 4 neutropenia (n = 1) |
CDD continuous daily dosing; DLT dose-limiting toxicity
aIf a DLT was experienced by only one of the three patients at any dose level, the cohort was expanded to six patients. If none of the additional three patients experienced a DLT, the dose was escalated to the next level. If DLTs occurred in ≥2 patients at any dose level, the dose level was deemed as having exceeded the MTD and the prior, lower dose level was further expanded (if only three patients were previously treated at that dose level). The MTD was defined as the dose level at which no more than one patient in a cohort of six experienced a DLT during the first 22 days of treatment of each schedule
bMaximum tolerated dose (MTD)