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 |
Including seven patients at level 2 of phase 1 portion.