Summary of solid tumor dosing cohorts and DLT events
| Level | Gemcitabine dose (mg/m2) | Pemetrexed dose (mg/m2) | Patients (n) | DLT event detail |
|---|---|---|---|---|
| 1 | 1,500 | 300 | 3 | No DLT-evaluable patients experienced DLT |
| 2 | 1,500 | 400 | 7 | 2 of 6 DLT-evaluable patients experienced DLT |
| Grade 3 thrombocytopenia, failure to recover ≤1 wk | ||||
| Febrile neutropenia | ||||
| 2* | 1,500 | 400 | 8 | 1 of 6 DLT-evaluable patients experienced DLT |
| Grade 3 thrombocytopenia, failure to recover ≤1 wk | ||||
| 3 | 1,500 | 500 | 9 | 1 of 9 DLT-evaluable patients experienced DLT |
| Febrile neutropenia | ||||
| 4 | 1,500 | 600 | 3 | 2 of 3 DLT-evaluable patients experienced DLT |
| Grade 4 hyponatremia | ||||
| Grade 2 herpes zoster infection, failure to resolve ≤1 wk |
↵* After the initial cohort treated at dose level 2, the protocol was amended to limit enrollment to patients with ≤2 prior regimens of cytotoxic chemotherapy and to exclude patients with prior whole-brain radiation therapy. Treatment was continued starting at dose level 2. Although 8 patients were enrolled on dose level 2*, 2 patients were replaced in that cohort because they were not considered evaluable for DLT. Please see text for details.