Dose level | Irinotecan (mg/m2) | No. of patients | Neutropenia grade | Thrombocytopenia grade | Anaemia grade | Febrile neutropenia | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
1 | 2 | 3 | 4 | 1 | 2 | 3 | 4 | 1 | 2 | 3 | 4 | |||||
Phase I | I | 250 | 6 | 0 | 1 | 1 | 4 | 2 | 0 | 1 | 0 | 2 | 3 | 0 | 0 | 1 |
II | 300 | 8 | 1 | 0 | 3 | 2 | 1 | 0 | 0 | 0 | 0 | 2 | 0 | 1 | 0 | |
Overall | 14 | 1 (7%) | 1 (7%) | 4 (29%) | 6 (43%) | 3 (21%) | 0 | 1 (7%) | 0 | 2 (14%) | 5 (36%) | 0 | 1 (7%) | 1 (7%) | ||
Phase II | 250 | 49 | 3 (6%) | 6 (12%) | 7 (14%) | 31 (63%) | 8 (16%) | 1 (2%) | 0 | 1 (2%) | 11 (22%) | 9 (18%) | 2 (4%) | 0 | 3 (6%) |