. Author manuscript; available in PMC: 2010 Jan 15.

Published in final edited form as: Clin Cancer Res. 2009 Jan 15;15(2):701–707. doi: 10.1158/1078-0432.CCR-08-1923

Table 2.

Summary of Toxicities During the Dose-Limiting Toxicity-Evaluation Period

	70mg/m² (n=7) ^§				90mg/m² (n=3)		120mg/m² (n=7) ^‡				160mg/m² (n=6)

Range of Actual Dosage (mg/m²)	68–83				85–87.5		107–128				151.5–167

Toxicity (Grade)	1	2	3	4	1	2	1	2	3	4	1	2	3	4

Lymphopenia	1	3	1 ^¶	2 ^¶	1	2	2	2	1 ^¶	1 ^¶	-	-	3 ^¶	1 ^¶
Rash	1	5	-	-	1	2	5	2	-	-	1	2	1 ^†	-
Diarrhea	2	-	-	-	3	-	5	-	1 ^†	-	4	-	-	-
Nausea	5	-	-	-	2	-	2	1	-	-	3	-	-	-
Vomiting	3	1	-	-	1	-	-	2	-	-	2	-	-	-
Hypokalemia	1	-	2 ^¶	-	-	-	1	-	1 ^¶	-	2	-	-	-
Hypophosphatemia	2	1	1 ^¶	-	-	1	-	-	-	-	1	1	-	-
Indirect hyperbilirubinemia	-	-	-	-	1	-	2	-	-	-	-	2	-	-
Mucositis	-	-	-	-	1	2	1	1	-	-	-	1	-	-
Fatigue	2	1	-	-	-	-	1	-	-	-	2	-	-	-
Anorexia	2	-	-	-	1	1	1	1	-	-	1	2	-	-
Elevation of SGPT	2	-	-	-	2	-	3	-	-	-	1	-	-	-
Infection without neutropenia	-	3	1 ^¶	-	1	-	1	4	-	-	1	3	-	-
Increase of serum lipase	-	-	-	-	-	-	-	-	-	-	-	-	1 ^†	-

^§

Four patients were treated before and three patients after the study was amended to exclude grade 3 and 4 electrolyte abnormalities that resolved to at least grade 2 within 7 days

^‡

One patient was not assessable for toxicity because of early tumor progression

^†

dose-limiting toxicity

^¶

These toxicities were not considered dose-limiting toxicities according to the study criteria