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%) |