Table 4.

Nonhematologic toxicity (grade 2 or more)

Dose level 1 (4 patients) 1st cycle (all cycles)
Dose level 2 (3 patients) 1st cycle (all cycles)
Dose level 3 (10 patients) 1st cycle (all cycles)
Dose level 4 (4 patients) 1st cycle (all cycles)
G2G3G4G2G3G4G2G3G4G2G3G4
Fatigue0 (3)0 (1)0 (0)0 (2)0 (0)0 (0)3 (4)1 (1)0 (0)1 (1)2 (2)*0 (0)
Anorexia1 (2)0 (0)0 (0)0 (0)0 (0)0 (0)3 (4)1 (1)0 (0)1 (1)0 (0)0 (0)
Nausea/vomiting0 (1)0 (0)0 (0)1 (1)0 (0)0 (0)4 (4)1 (1)0 (0)3 (3)0 (0)0 (2)
Mucositis1 (3)0 (0)0 (0)1 (1)0 (0)0 (0)1 (1)0 (0)0 (0)1 (2)0 (0)0 (0)
Diarrhea1 (1)0 (0)0 (0)0 (0)0 (0)0 (0)2 (4)0 (0)0 (0)0 (0)1 (1)*0 (0)
Dehydration0 (0)0 (0)0 (0)0 (0)0 (1)0 (0)2 (2)1 (1)0 (0)0 (0)0 (0)0 (0)
Neuropathy0 (0)0 (0)0 (0)0 (2)0 (1)0 (0)0 (0)0 (1)0 (0)0 (0)0 (0)0 (0)
Infection0 (0)0 (0)0 (0)0 (0)0 (1)0 (0)0 (0)0 (0)0 (0)1 (1)0 (0)0 (0)
Weight loss0 (0)0 (0)0 (0)0 (0)0 (0)0 (0)1 (1)0 (0)0 (0)0 (1)0 (0)0 (0)
LFT elevation0 (0)0 (0)0 (0)0 (0)0 (0)0 (0)2 (2)0 (0)0 (0)0 (0)0 (0)0 (0)
Headaches0 (0)0 (0)0 (0)0 (0)0 (0)0 (0)0 (0)0 (0)0 (0)0 (2)0 (0)0 (0)
  • NOTE: All cycles toxicities are listed in between parenthesis.

    Abbreviation: LFT, liver function test.

  • * Three patients experienced dose-limiting toxicity: one patient on dose level 3 experienced grade 3 nausea/vomiting, fatigue, anorexia, and dehydration; and two patients at dose level 4 experienced grade 3 fatigue, one of who had an associated grade 3 diarrhea.