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 |