Table 3.
Reported and ongoing trials of targeted agents in muscle-invasive bladder cancer
| Table 3a. Reported trials of targeted agents with chemotherapy in muscle-invasive bladder cancer | |||||||
|---|---|---|---|---|---|---|---|
| Author | Year | Agent | Target | Chemotherapy | Study type | n | Path <T2 RR% |
| Chaudhary [40] | 2011 | Bevacizumab | VEGF | Gemcitabine and cisplatin | Phase II neoadjuvant | 15 | 31 |
| Siefker-Radtke [38] | 2012 | Bevacizumab | VEGF | Dose-dense MVAC | Phase II neoadjuvant | 60 | 53 |
| Balar [41] | 2012 | Sunitinib | VEGFR-1/2, C-KIT, PDGFR a/b, FLT3, RET | Gemcitabine and cisplatin | Phase II neoadjuvant | 18 | 33 |
| Galsky [39] | 2013 | Sunitinib | VEGFR-1/2, C-KIT, PDGFR a/b, FLT3, RET | Gemcitabine and cisplatin | Phase II neoadjuvant | 9 | 22 |
| Table 3b. Reported trials of targeted agents as single-agent therapy in muscle-invasive bladder cancer | |||||||
| Author | Year | Agent | Target | Chemotherapy | Study type | n | Path <T2 RR% |
| Pruthi [42] | 2010 | Erlotinib | EGFR | None | Phase II neoadjuvant | 20 | 35 |
| Hahn [43] | 2012 | Dasatinib | BCR/ABL and Src | None | Phase II neoadjuvant | 25 | 14 |
| Table 3c. Ongoing trials of targeted agents with chemotherapy in muscle-invasive bladder cancer | |||||||
| PI/group | Start Year | Agent | Target | Chemotherapy | Study type | Target enrollment | Clinicaltrials.gov ID |
| Michaelson RTOG [54] | 2005 | Trastuzumab | HER2 | Paclitaxel and radiation | Phase I/II adjuvant | 88 | NCT00238420 |
| Kraft [52] | 2005 | Bevacizumab | VEGF | Neoadjuvant gemcitabine and cisplatin adjuvant paclitaxel | Phase II neoadjuvant and adjuvant | 25 | NCT00268450 |
| Bradley [55] | 2010 | CDX-1307 | Dendritic-cell vaccine hCG-B | Gemcitabine and cisplatin | Phase II neoadjuvant and adjuvant | 30 | NCT01094496 |
| Wong [56] | 2011 | ALT-801 | p53 | Gemcitabine and cisplatin; gemcitabine alone | Phase Ib/II neoadjuvant or metastatic | 76 | NCT01326871 |
| Table 3d. Ongoing trials of targeted agents as single therapy in muscle-invasive bladder cancer | |||||||
| PI/group | Start Year | Agent | Target | Chemotherapy | Study type | Target enrollment | Clinicaltrials.gov ID |
| So [57] | 2009 | OGX-427 | Hsp27 | None | Phase I neoadjuvant | 36 | NCT00959868 |
| Bajorin [58] | 2011 | DN24–02 | HER-2 vaccine | None | Randomized phase II adjuvant | 180 | NCT01353222 |
| Mulders [59] | 2011 | recMAGE-A3þAS-15 | MAGE-A3 vaccine | None | Randomized phase II adjuvant | 273 | NCT01435356 |
| Wood [53] | 2013 | Dendritic-cell vaccine | Ad/HER2/neu | None | Phase I adjuvant | 65 | NCT01730118 |
EGFR, epidermal growth factor receptor; HER, human epidermal growth factor receptor; n, number of patients enrolled; PI, principal investigator; RR, pathologic response rate to <pT2; VEGF, vascular endothelial growth factor.