Table 3. Toxicity incidence.
| Course | Phase I portion First course | Phase II portiona All courses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| |
||||||||||
| CPT-11 (mg m−2) | 70 | 80 | 90 | 100 | 80 | |||||
| No.of patients |
3
|
7
|
3
|
3
|
42
|
|||||
| Toxicity/grade | All events | Grade 3/4 | All events | Grade 3/4 | All events | Grade 3/4 | All events | Grade 3/4 | All events | Grade 3/4 |
| Haematological | ||||||||||
| Leucopenia | 1 | 0 | 3 | 0 | 1 | 0 | 3 | 1 | 24 | 5 |
| Neutropenia | 0 | 0 | 3 | 0 | 1 | 0 | 3 | 1 | 20 | 6 |
| Anaemia | 1 | 0 | 0 | 0 | 2 | 0 | 2 | 1 | 20 | 3 |
| Thrombocytopenia | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 5 | 2 |
| Nonhaematological | ||||||||||
| Anorexia | 3 | 0 | 3 | 0 | 2 | 0 | 2 | 1 | 23 | 4 |
| Nausea | 3 | 0 | 4 | 0 | 2 | 0 | 2 | 1 | 25 | 3 |
| Vomiting | 0 | 0 | 1 | 0 | 2 | 0 | 1 | 1 | 16 | 2 |
| Diarrhoea | 0 | 0 | 1 | 1 | 1 | 0 | 1 | 1 | 17 | 4 |
a
Including seven patients at level 2 of phase 1 portion.