Table 2.
Phase I combination studies of bortezomib in advanced solid tumors
| Number of patients | 21 | 14 | 25 | 51 | 31 | 29 |
|---|---|---|---|---|---|---|
| Schedule | Starting dose of 0.5 mg/m2 iv twice weekly + 5-FU 500 mg/m2 + leucovorin 20 mg/m2 on day 1 q2 weeks | Starting dose of 0.8 mg/m2 iv on days 2, 5, 9, 12 + docetaxel 25 mg/m2 on days 1, 8 q3 weeks | Starting dose of 0.6 mg/m2 iv on days 2, 5, 9, 12 + paclitaxel 80 mg/m2 on days 1, 8 q3 weeks | Starting dose of 1.3 mg/m2 iv twice a week + irinotecan 125 mg/m2 on days 1, 8 q3 weeks | Starting dose of 1.0 mg/m2 iv twice a week + gemcitabine 1000 mg/m2 on days 1, 8 q3 weeks | Starting dose of 1.0 mg/m2 iv on days 1, 4, 8, 11 + FDr gemcitabine 750, 1000, 1250 mg/m2 on days 1, 8 q3 weeks |
| Best response obtained | 1 PR | 4 SD | 1 PR | 10 SD | 1 PR | 1 PR |
| 8 SD | 7 SD | 6 SD | ||||
| Toxicity observed | Abdominal pain and diarrhea | Hematologic | Neurotoxicity and fatigue | Diarrhea, nausea and vomiting | Abdominal pain and hematologic | Neutropenia and thrombocytopenia |
Abbreviations: FDR, fixed dose rate; PR, partial response; SD, stable disease; 5FU, 5-fluorouracil.