Table 3.
Phase I/III trials of gemcitabine in combination with novel targeted therapies
| Combination | OS (mo) | P | PFS (mo) | P | ORR (%) | SD (%) | |
| Phase II trial | |||||||
| Xiong et al[41] (n = 61) | Gem + Cetuximab | 7.1 | 3.8 | 12.2 | 63.4 | ||
| Fogelman et al[47] (n = 50) | GemOx + BEV | 12.1 | NR | NR | 39 | ||
| Kim et al[48] (n = 82) | GemOx + BEV | 8.1 | 5.7 | 11.3 | NR | ||
| Ko et al[49] (n = 57) | Gem + Cetuximab + BEV | NR | 3.5 | 10.7 | 29 | ||
| Cetuximab + BEV | 1.8 | 0 | 24 | ||||
| Kindler et al[50] (n = 139) | Gem + BEV + Erlotinib | 7.8 | 5.0 | 23 | 49 | ||
| Gem + BEV + Cetuximab | 7.2 | 5.1 | 18 | 45 | |||
| Phase III trial | |||||||
| Moore et al[40] (n = 569) | Gem + Erlotinib | 6.37 | 0.038 | NR | 0.004 | ||
| Gem | 5.91 | ||||||
| Philip et al[43] (n = 735) | Gem + Cetuximab | 6.5 | 0.14 | 3.5 | 0.058 | ||
| Gem | 6.0 | 3.0 | |||||
| Kindler et al[45] (n = 602) | Gem + BEV | 5.7 | NS | 4.8 | NS | ||
| Gem | 6.0 | 4.3 | |||||
| Vervenne et al[46] (n = 607) | Gem + BEV | 7.1 | NS | 4.6 | 0.0002 | ||
| Gem | 6.0 | 3.6 |
ORR: Overall response rate; SD: Stable disease; NR: Not reported; NS: Not significant; BEV: Bevacizumab; Gem: Gemcitabine; Gem FDR: Gemcitabine fixed-dose rate; GemOx: Gemcitabine 1000 mg/m2 iv over 100 min on day 1 plus oxaliplatin 100 mg/m2 on day 2 every 14 d.