Table 2.
Dose escalation scheme and DLT
Level | Oxaliplatin (mg/m2) | Irinotecan (mg/m2) | Capecitabine (mg PO BID) | Number of patients | Gender | Type of DLT and Gender |
---|---|---|---|---|---|---|
1A | 60 | 40 | 1,000 | 4 | 3 M/1F | 2 grade 3 diarrhea (1 M/1F) |
1 | 60 | 40 | 300 | 3 | 1 M/2F | None |
2 | 60 | 40 | 450 | 6 | 4 M/2F | None, see note |
3 | 60 | 50 | 450 | 6 | 4 M/2F | 1 grade 3 nausea, vomiting, diarrhea (1 M) |
4 | 60 | 60 | 450 | 3 | 1 M/2F | 3 grade 3 diarrhea (1 M/2F) |
Transient grade 3 hyponatremia in 1 patient led to cohort expansion but was subsequently determined not to be DLT
M male, F female