Table 3.
Phase I trials combining sorafenib with chemotherapy
| Study population | Patients (n) | Agent | End points | Reference |
|---|---|---|---|---|
| Refractory solid tumors (n = 15) and metastatic melanoma (n = 24) | 39 | Sorafenib (100, 200, 400 mg bid) Carboplatin (AUC6) and paclitaxel (225 mg/m2) | DLT: 6 rash, 1 hypertension Melanoma: 1 CR, 9 PR, PFS 10.2 m, RR 26% | ( 54 ) |
| Refractory solid tumors (n = 27) and CRC (n = 10) | 37 | Sorafenib (200, 400 mg bid) Oxaliplatin (130 mg/m2) | MTD not reached DLT: 2 diarrhea gr 3. 2 PR (6%), SD >10 w 43% solid tumors, 78% CRC | ( 53 ) |
| Refractory solid tumors (n = 19) and pancreatic cancer (n = 23) | 42 | Sorafenib (100, 200, 400 mg bid) Gemcitabine (1000 mg/m2) | MTD not reached DLT: 1 fatigue gr 3 2 PR (11%), 25 SD | ( 52 ) |
| Refractory solid tumors (n = 34) and advanced HCC (n = 18) | 52 | Sorafenib (100, 200, 400 mg bid) Doxorubicin (60 mg/m2) | MTD not reached DLT: 7 HFSR 1 gr 3 diarrhea Solid tumor: 1 PR, 15 SD (48%) HCC: 1 PR (6%), 10 SD (63%) | ( 50, 51, 53 ) |
| Refractory solid tumors (n = 20) and CRC (n = 14) | 34 | Sorafenib (100, 200, 400 mg bid) Irinotecan (125 mg/m2 or 140 mg) | MTD not reached DLT: 1 hemorrhage, 2 HFSR 22 SD (67%), 1 PR | ( 55 ) |
CR, complete response; CRC, colorectal carcinoma; DLT, dose‐limiting toxicity; HCC, hepatocellular carcinoma; HFRS, hand–foot skin reaction; MTD, maximum tolerated dose; PFS, progression‐free survival; PR, partial response; RR, response rate; SD, stable disease.