Table 2 Incidence of DLTs during dose escalation

From: A phase I clinical and pharmacokinetic study of capecitabine (Xeloda®) and irinotecan combination therapy (XELIRI) in patients with metastatic gastrointestinal tumours

   

No. of patients

Dose level

Capecitabine (mg m −2 twice daily)

Irinotecan (mg m−2)

Treated

With DLT

DLTs

1

700

200

4

0

 

2

850

200

3

0

 

3

1000

200

4

0

 

4

1000

250

10

1

Grade 3 diarrhoea, Grade 4 neutropenia/septicaemia

5

1150

250

6

3

Grade 3 diarrhoea/abdominal pain

     

Grade 3 diarrhoea/Grade 4 neutropenia

     

Grade 4 diarrhoea/Grade 3 vomiting

  1. DLTs=dose-limiting toxicities.