Table 1. Dose Escalation Scheme.
| Dose level |
Dose (mg/m2) |
UGT1A1
*28/*28 |
UGT1A1
*1/*28 |
UGT1A1
*1/*1 |
|---|---|---|---|---|
| −2 | Iri 75 Oxal 85 Cap 400 |
6 | ||
| −1 | Iri 100 Oxal 85 Cap 400 |
3 (2) | ||
| 1* | Iri 150 Oxal 85 Cap 400 |
2 (1) | 3 + 9 | |
| 2** | Iri 150 Oxal 85 Cap 800 |
6 (2) | 3 | |
| 3 | Iri 150 Oxal 120 Cap 800 |
3 | ||
| 4 | Iri 150 Oxal 120 Cap 1600 |
3 + 9 (5) | ||
| 5 | Iri 175 Oxal 120 Cap 1600 |
3 (2) |
Table 2: Dose escalation schema for irinotecan (Iri), oxaliplatin (oxal) and capecitabine (cap).
*
Starting dose level for UGT1A1 *28/*28 and *1/*28 patients
**
Starting dose level for UGT1A1 *1/*1 patients
( ) Dose limiting toxicity