Table 5.

Summary of ovarian cancer dosing cohorts and DLT events

LevelGemcitabine dose (mg/m2)Pemetrexed dose (mg/m2)Patients (n)DLT event detail
11,5003004*No DLT-evaluable patients experienced DLT
21,5004003No DLT-evaluable patients experienced DLT
31,50050061 of 6 DLT-evaluable patients experienced DLT
    Grade 3 thrombocytopenia, failure to recover ≤1 wk
41,50060092 of 9 DLT-evaluable patients experienced DLT
    2 patients with febrile neutropenia
51,50070022 of 2 DLT-evaluable patients experienced DLT
    Febrile neutropenia
    Grade 3 rash
  • * One patient was removed from the dose level 1 cohort for probable disease progression and a fourth patient was added to meet protocol requirements for DLT assessment.