Table 3

Summary of ongoing gastrointestinal tract and pancreas (GEP) neuroendocrine tumour (NET) systemic therapy clinical trials

Sponsor/trial lead trial phase Trial design Target population Primary end point
Novartis, Bayer Dana-Farber/Harvard Cancer Center Ph I NCT00942682 Sorafenib plus RAD001 Advanced low- or intermediate-grade unresectable carcinoid or pancreatic NET Safety maximum tolerated dose (MTD)
Novartis Dana-Farber/Harvard Cancer Center Ph I NCT00804336 Pasireotide (somatostatin analogue with affinity for somatostatin receptor 1,2,3,5) plus RAD001 Unresectable or metastatic low- or intermediate-grade NET Safety MTD
NCI UCSF Helen Diller Family Comprehensive Cancer Center Ph I/II NCT00227617 Fluorouracil, leucovorin and oxaliplatin (FOLFOX) plus bevacizumab Advanced NETs, carcinoid, pancreatic islet cell, poorly differentiated NETs of any primary site Safety RR
Dana-Faber Cancer Institute Ph I/II NCT00576680 RAD001 plus temozolomide Advanced pancreatic NETs Safety RR
Stanford Cancer Center Ph II NCT00398320 Capecitabine, oxaliplatin and bevacizumab Metastatic/unresectable NETs TTP
Hoffman-LaRoche Ph II NCT00448136 Streptozotocin/5FU plus bevacizumab (duodeno-pancreatic) Well-differentiated GI or duodeno-pancreatic NETs Safety RR
Capecitabine plus bevacizumab (GI)
MD Anderson Cancer Center, Texas Ph II NCT00454363 Pazopanib Low- or intermediate-grade advanced carcinoid or pancreatic islet cell carcinoma RR
Cambridge, UK Randomised Ph II NCT00602082 Cap-strep versus Cap-cist NETs of foregut, unknown primary, progressing disease RR
Stanley S Scott Cancer Center, New Orleans Ph II NCT00590343 PTK787/ZK222584 (vatalanib) Metastatic NETs with biochemical evidence of disease Biochemical RR and symptom relief
Toronto Western Hospital Ph I/II NCT00605566 Sorafenib plus cyclophosphamide Advanced progressive NETs Toxicity
Pharmaco-dynamic end points
Memorial Sloan-Kettering Cancer Center Ph II NCT00610129 MK-0646 humanised monoclonal antibody to IGF1R Metastatic well-differentiated NETs
Holden Comprehensive Cancer Center, Iowa Ph II NCT00627198 PTK787/ZK222584 (vatalanib) plus Sandostatin LAR Progressing NETs with biochemical evidence of disease RR and biochemical RR
ImClone LLC Ph II NCT00781911 Cixutumumab (IMC-A12, targeting IGF1R) plus depot octreotide Well- or moderately differentiated metastatic NET 6-month PFS
UCSF Helen Diller Family Comprehensive Cancer Center Ph II NCT00843531 RAD001 plus erlotinib Well- to moderately-differentiated NET: low- or intermediate-grade, islet cell carcinoma, pancreatic NET, carcinoid, atypical carcinoid, paraganglioma, pheochromocytoma Safety RR
Herbert Irving Comprehensive Cancer Center, Columbia Ph II NCT00869050 Temozolomide plus capecitabine Progressive metastatic NET RR Safety
Genentech Stanford Cancer Center Ph II NCT00947167 Pertuzumab (HER2 inhibiting monoclonal antibody) as monotherapy plus erlotinib Unresectable or metastatic well-differentiated NET RR
Novartis Ph III Sandostatin LAR +/−RAD001 Carcinoids PFS
Novartis Ph II 5FU+strep+Sandostatin LAR versus 5FU+strep+Pasireotide LAR Non-functional pancreatic RR, TTP
Beaufour Ipsen International Ph III NCT00353496 Lanreotide versus placebo Locally advanced or metastatic well- or moderately differentiated GEP NETs with no hormone-related symptoms PFS

This Article

  1. Endocr Relat Cancer vol. 17 no. 1 R75-R90