Table 1. Dose-escalation scheme and principal toxicities in the phase I portion of the trial (n=33).
| Dose level | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | |
|---|---|---|---|---|---|---|---|---|---|
| Docetaxel (mg m−2) | 20 | 25 | 30 | 30 | 30 | 35 | 40 | 45 | |
| Cisplatin (mg m−2) | 30 | 30 | 30 | 35 | 40 | 40 | 40 | 40 | |
| No. of patients | 6 | 3 | 3 | 3 | 3 | 3 | 6 | 6 | |
| No. of DLTs | 2 | 0 | 0 | 0 | 1 | 0 | 1 | 4 | |
| Principal toxicitya | |||||||||
| Oesophagitis | G3 | 2 (2)b | 1 (1) | 2 (2) | |||||
| Liver | G3 | 1 (1) | |||||||
| Granulocytopenia | G3 | 1 | 1(1) | 1 | 4 (1) | 2 (1) | |||
| G4 | 2 (1) | ||||||||
| Anaemia | G3 | 1 | 1 | ||||||
| G4 | 1 | 1 | |||||||
| Thrombocytopenia | G3 | 1 (1) |
DLT=dose-limiting toxicity; G3=grade 3; G4=grade 4.
a
Toxicity was assessed and graded using ECOG common toxicity criteria (Oken et al, 1982), and grading of acute oesophageal toxicity due to radiation was evaluated in accordance with RTOG/ EORTC radiation acute toxicity criteria (Cox et al, 1995).
b
Number of patients with grade 3 or 4 toxicity (numbers in parentheses indicate number of patients with the DLT).