Beyond first-line chemotherapy for advanced pancreatic cancer: An expanding array of therapeutic options?

Table 4 Ongoing randomized phase II/III trials of refractory pancreatic cancer chemotherapy

Clinical trial	Design	Study arms	Goal enrollment	Primary measure	Previous therapy	Status
NCT00674973	Phase II	Erlotinib vs placebo	207	PFS, biomarkers	1 prior CT regimen	Active, not recruiting
NCT01074996	Phase II	S-1 vs S-1, leucovorin	96	OS	Gem-based	Recruiting
NCT01417000	Phase II	GVAX pancreas, cyclophosphamide, CRS-207 vs GVAX pancreas, cyclophosphamide	90	OS	≥ 1 prior CT regimen	Active, not recruiting
NCT01423604	Phase II	Capecitabine, ruxolitinib vs capecitabine, placebo	138	OS	Gem-based	Active, not recruiting
NCT01658943	Phase II	Selumetinib, MK2206 vs FOLFOX	133	OS, PFS	Gem-based	Recruiting
NCT01796782	Phase II	QYHJ granules vs Capecitabine	60	OS	Non-capecitabine containing CT	Active, not recruiting
NCT01121848	Phase III	Capecitabine or 5-FU, leucovorin vs XELOX or mFOLFOX-6	128	PFS	Gem-based	Active, not recruiting
NCT01494506	Phase III	MM-398 vs MM-398, 5-FU, leucovorin vs 5-FU, leucovorin	405	OS	Gem-based	Active, not recruiting
NCT01954992	Phase III	Glufosfamide vs 5-FU	480	OS	Gem-based	Recruiting
NCT01956812	Phase III	Gemcitabine, IMMU-107 vs Gemcitabine, placebo	440	OS	2 prior CT regimens, ≥ 1 Gem-based	Not yet open for recruitment

GVAX pancreas: Allogeneic pancreatic cancer cell vaccine, induces GM-CSF production; CRS-207: Attenuated listeria monocytogenes vaccine, induces immune response to mesothelin; MK2206: Akt inhibitor; FOLFOX: 5-Fluorouracil, leucovorin, oxaliplatin; QYHJ: Qingyihuaji formulation; 5-FU: 5-Fluorouracil; XELOX: Capecitabine, oxaliplatin; mFOLFOX-6: Modified schedule 5-fluorouracil, leucovorin, oxaliplatin; MM-398: Liposomal irinotecan; IMMU-07: Yttrium-90 radiolabeled humanized monoclonal antibody against mucin1 (CD227); PFS: Progression free survival; OS: Overall survival; CT: Chemotherapy; Gem-based: Gemcitabine-containing chemotherapy regimen.