Table 3. Dose escalation toxicity.

Adverse event	Dose level
	Level I				Level II					Level III					Level IV
	N= 5				N= 6					N= 3					N= 8
Grade of adverse event	1	2	3	4	1	2	3	4	5	1	2	3		4	1	2	3	4
Blood/bone marrow
Hemoglobin	2	1			5		1*			1	1				3	1
White blood cells	2	1			2	2		1*					2			3	3
Neutrophils			2		1	1		1*		2							5
Platelets							1*
Cardiac						1		1*								1
Coagulation
Constitutional		3			3	1				2	1				4	1
Dermatology	2				2					2	1				3
Endocrine					2
Gastrointestinal	2				2	2	1ˆ	1*		1	2				4	1
Genitourinary		1
Hemorrhage
Hepatobiliary											1
Infection	1					1			1*							1
Metabolic	2	1			2	1	2 @	1*							2	1
Neurologic	1				2	1				2					1	1
Ocular/visual	2									1
Pain		1			1					1	1				3	1
Pulmonary								1*								1
Sexual		1

Dose Level II:

^*Colo-vesical fistula with pancytopenia, metabolic toxicity (hypocalcemia), hypotension, respiratory distress, and death occurring in a single patient.

Dose Level II:

^ˆGrade 3 Nausea and vomiting and

^@hypokalemia were not DLTs in this study.