Table 2.

Summary of solid tumor dosing cohorts and DLT events

LevelGemcitabine dose (mg/m2)Pemetrexed dose (mg/m2)Patients (n)DLT event detail
11,5003003No DLT-evaluable patients experienced DLT
21,50040072 of 6 DLT-evaluable patients experienced DLT
    Grade 3 thrombocytopenia, failure to recover ≤1 wk
    Febrile neutropenia
2*1,50040081 of 6 DLT-evaluable patients experienced DLT
    Grade 3 thrombocytopenia, failure to recover ≤1 wk
31,50050091 of 9 DLT-evaluable patients experienced DLT
    Febrile neutropenia
41,50060032 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.