Table 2. Gemcitabine/Dasatinib and Gemcitabine/Dasatinib/Cetuximab Dosing.
Shown here are the dose levels for GD and GDC cohorts. The dose and frequency of gemcitabine (GD and GDC arms), dasatinib (GD and GDC arms), and cetuximab (GDC arm) are listed. The number of evaluable patients treated at each level (n treated) and number of DLTs (n DLTs) are listed.
| Dose Level | Gemcitabine (mg/m2) IV over 30 minutes, days 1, 8, 15 | Dasatinib (mg) PO BID continuous | Cetuximab IV days 1, 8, 15, 22a (mg/m2) | n treated | n DLTs |
|---|---|---|---|---|---|
| GD-1 | 1000 | 40 | 0 | 0 | 0 |
| GDC-1 | 250 | 0 | 0 | ||
| GD1 | 1000 | 50 | 0 | 6 | 0 |
| GDC1 | 250 | 6 | 1 | ||
| GD2 | 1000 | 70 | 0 | 3 | 2 |
| GDC2 | 250 | 5b | 1 | ||
| GD3 | 1000 | 100 | 0 | 0 | 0 |
| GDC3 | 250 | 0 | 0 |
a
GDC arms only. First dose of cetuximab will be a loading dose of 400 mg/m2 IV day 1 cycle 1 only. The remainder of the doses will be 250 mg/m2 IV.
b
Three of five patients on GDC2 came off treatment due to toxicity.