|
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%)
|
- *Patient may have more than one dose-limiting toxicity (DLT). **Fever ≥38.0°C with concomitant grade 3–4 neutropenia in the absence of documented infection.
