Table 2

Dose levels

Dose level/scheduleNo. of patients (no. who completed first cycle)Total no. of cyclesMedian no. of cycles (range)DLTs
DL 1: 4 mg/m2 × 2/4 wk 5 (5) 2 (1-4)* 1 
DL 2: 6 mg/m2 × 2/4 wk 5 (4) 9* 
DL 3: 8 mg/m2 × 2/4 wk 3 (3) 
DL 4: 8 mg/m2 × 4/6 wk 15 (9) 27 1 (1-5) 
DL 5: 10 mg/m2 × 4/6 wk 10 (5) 12 1 (1-2) 5 
Dose level/scheduleNo. of patients (no. who completed first cycle)Total no. of cyclesMedian no. of cycles (range)DLTs
DL 1: 4 mg/m2 × 2/4 wk 5 (5) 2 (1-4)* 1 
DL 2: 6 mg/m2 × 2/4 wk 5 (4) 9* 
DL 3: 8 mg/m2 × 2/4 wk 3 (3) 
DL 4: 8 mg/m2 × 4/6 wk 15 (9) 27 1 (1-5) 
DL 5: 10 mg/m2 × 4/6 wk 10 (5) 12 1 (1-2) 5 
*

Two patients enrolled at level 1 each received 2 subsequent cycles at level 2.

Fatigue.

Infections (3), neurologic toxicity (1), and abnormal laboratory parameters (1).

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