Phase I/II study of first-line irinotecan combined with 5-fluorouracil and folinic acid Mayo Clinic schedule in patients with advanced colorectal cancer

Table 2 Dose-limiting toxicity during first cycle of irinotecan combined with 5-FU/FA Mayo Clinic schedule according to dose levels in phase I study (n = 14)

Dose level	I	II	Overall
Irinotecan (mg/m²)	250	300	250/300
5-FU (mg/m²)	425	425	425
FA (mg/m²)	20	20	20
No. of cycles:
Total number	18	42	60
Median [range]	3 [1–6]	6 [2–8]	4 [1–-8]
No. of patients	6	8	14
Dose limiting toxicity (grade)*:
Any grade 3–4 non-haematological toxicity:	4	4	8
Pain (3)	-	1	1
Stomatitis (3)	1	-	1
Nausea (3)	2	-	2
Fatigue (3)	2	1	3
Pulmonary (4)	1	-	1
Diarrhoea (3–4)	2	3	5
Febrile neutropenia**	1	0	1
Grade 3–4 infection	0	0	0
Grade 3–4 neutropenia with severe infection	0	1	1
No. patients with at least one DLT	4 (67%)	4 (50%)	8 (57%)

*Patient may have more than one dose-limiting toxicity (DLT). **Fever ≥38.0°C with concomitant grade 3–4 neutropenia in the absence of documented infection.