Table 4. Toxicity in feasibility phase for four cycles (N= 40 patients).

Adverse event
Grade of adverse event	0	1	2	3	4
Allergy	34	3	3	0	0
Auditory	37	0	3	0	0
Blood/bone marrow
Hemoglobin	3	14	17	6	0
Neutrophils	0	1	1	4	34 +
Platelets	15	17	6	1	1*
Cardiac	37	2	1	0	0
Coagulation	39	1	0	0	0
Constitutional	6	17	16	1@	0
Dermatologic	5	16	19	0	0
Endocrine	36	3	1	0	0
Gastrointestinal	3	17	15	4@ £ †	1ˆ
Genitourinary	31	6	3	0	0
Hemorrhage	34	6	0	0	0
Hepatic	39	0	0	1#	0
Infection	20	0	11	9	0
Febrile Neutropenia	33	-	-	7@ # &	0
Infection with Grade 0 ANC	39	0	1	0	0
Infection with Grade 3 or 4 ANC	28	-	10	2<	0
Lymphatic	36	4	0	0	0
Metabolic	20	11	5	3 $	1&
Musculoskeletal	38	1	1	0	0
Neurologic	19	18	2	1ˆ	0
Ocular	31	6	3	0	0
Pain	7	20	13	0	0
Pulmonary	30	7	3	0	0
Vascular	38	0	0	2# =	0

ANC- Absolute neutrophil count

Dose-limiting toxicities include:

⁺2 patients with grade 4 neutropenia prolonged >7 days

^*1 patient with grade 4 thrombocytopenia

^@7 patients with neutropenic fever: Of these 7 patients with neutropenic fever, one patient also had grade 3 gastrointestinal/constitutional toxicity

^#one also had grade 3 hepatic toxicity with prolonged LFT elevation /septic pelvic thrombophlebitis

^&one also had grade 4 hyponatremia

^<2 patients with grade 3 port infections and grade 3 neutropenia

⁼1 patient with pulmonary embolism

^£1 patient with grade 3 oral mucositis

^ˆ1 patient with grade 4 dehydration

^†Grade 3 nausea and vomiting

^$Grade 3 metabolic (hypokalemia) were not DLTs in this study.