Skip to main content

Table 2 Dose-limiting toxicity during first cycle of irinotecan combined with 5-FU/FA Mayo Clinic schedule according to dose levels in phase I study (n = 14)

From: Phase I/II study of first-line irinotecan combined with 5-fluorouracil and folinic acid Mayo Clinic schedule in patients with advanced colorectal cancer

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%)
  1. *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.