Table 4.
Non-hematological toxicities
| Dose level irinotecan/MMC (mg/m2) | No. of patients (cycles) | Number of cycles with
|
||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Nausea/vomiting |
Diarrhea |
Asthenia |
a Liver function abnormalities |
|||||||
| G1–2 | G3–4 | G1–2 | G3–4 | G1–2 | G3–4 | G1–2 | b G3–4 | |||
| 1. | 50/6, 6 weeks | 7 (11) | 0 | 1 | 3 | 1 | 1 | 0 | 14 | 1 |
| 50/4, 6 weeks | 1 (4) | |||||||||
| 2. | 75/6, 6 weeks | 9 (20) | 1 | 1 | 2 | 3 | 0 | 0 | 9 | 4 |
| 3. | 75/6, 4 weeks | 4 (14) | 0 | 0 | 5 | 0 | 3 | 1 | 0 | 0 |
| 50/6, 4 weeks | 2 (4) | |||||||||
| 4. | 100/6, 4 weeks | 8 (23) | 0 | 0 | 4 | 2 | 2 | 0 | 8 | 0 |
| 100/4, 4 weeks | 1 (3) | |||||||||
| 5. | 125/6, 4 weeks | 9 (34) | 0 | 0 | 7 | 1 | 1 | 1 | 0 | 0 |
| 125/4, 4 weeks | 1 (1) | 1 | 1 | 2 | 0 | |||||
| 6. | 150/6, 4 weeks | 3 (4) | 0 | 0 | 0 | 3 | 0 | 0 | 1 | 0 |
| 7. | 125/6/celecoxib | 2 (2) | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| 8. | 75/6/celecoxib | 5 (7) | 3 | 1 | 1 | 1 | 2 | 1 | 0 | 0 |
| 50/4/celecoxib | 2 (3) | 2 | 1 | 2 | ||||||
Italic indicates protocol amendment resulting in changes of cycle duration
a
Numbers in liver function abnormality indicate the sum of patients with elevations in alkaline phosphatase, total bilirubin, AST or ALT, one patient may be counted twice for two abnormalities
b
All patients had grade 3 toxicity, no one had grade 4 toxicity