Dose level | Phase I | Phase II | ||
---|---|---|---|---|
 | I | II | Overall |  |
Irinotecan (mg/m2) | 250 | 300 | 250/300 | 250 |
5-FU (mg/m2) | 425 | 425 | 425 | 425 |
FA (mg/m2) | 20 | 20 | 20 | 20 |
Number of patients | 6 | 8 | 14 | 49 |
Delayed diarrhoea | 4 | 4 | 8 (57%) | 16 (33%) |
Fatigue | 2 | 3 | 5 (36%) | 11 (22%) |
Pain | 3 | 1 | 4 (29%) | 9 (18%) |
Stomatitis | 4 | 1 | 5 (36%) | 13 (26%) |
Alopecia | 1 | 0 | 1 (7%) | 2 (4%) |
Nausea | 2 | 0 | 2 (14%) | 8 (16%) |
Anorexia | 1 | 1 | 2 (14%) | 0 |
Vomiting | 1 | 0 | 1 (7%) | 7 (14%) |
Fever | 0 | 1 | 1 (7%) | 0 |
Infection | 0 | 0 | 0 | 8 (16%) |