Clinical Trials In the News:
On January 12, that the New England Journal of Medicine published the results of the NETTER-1 Phase III study evaluating efficacy and safety of Lutathera® (lutetium-177 dotatate), an investigational drug, in patients with advanced, progressive somatostatin receptor-positive midgut neuroendocrine tumors (“NETs”).
Jonathan Strosberg, MD, Associate Professor, Section Head, Neuroendocrine Tumor Program at Moffitt Cancer Center, and lead author of the publication noted, “The clinically meaningful and statistically significant improvement in PFS and ORR achieved with treatment of Lutathera®, when compared to high dose Octreotide supports its potential utility in the treatment of NET patients. As a clinician treating many patients with this condition, these results bring hope for our ability to improve lives.”
The New England Journal of Medicine publication may be found online by clicking here.
Currently Recruiting Trials of Interests:
Randomized Embolization Trial for NeuroEndocrine Tumor Metastases To The Liver
NCCN, NANETS, and ENETS guidelines all recommend embolotherapy for progressive or symptomatic unresectable NET liver metastases, with no recommendation among the different techniques of embolization. This study compares the efficacy and safety of three types of hepatic embolization. The primary aim of this trial is to estimate the duration of hepatic progression-free survival (HPFS) in participants treated with bland embolization (BE), transcatheter arterial Lipiodol chemoembolization (TACE), and embolization by drug-eluting-eluting beads (DEB). Clinical trials.gov - NCT02724540. If you are interested in opening this trial at your facility, please contact Michael Soulen, MD at email@example.com
Efficacy and Safety of Lanreotide Autogel/ Depot 120 mg vs. Placebo in Subjects With Lung Neuroendocrine Tumors (SPINET)
While surgery remains the treatment of choice for patients with resectable tumors there are limited options for those with advanced or metastatic disease with unresectable tumors. The primary objective of this trial will be to compare the antitumour efficacy of Lanreotide Autogel/Depot 120 mg (LAN) plus Best Supportive Care (BSC) every 28 days versus placebo plus BSC, in terms of progression free survival (PFS), measured by central review using Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 criteria, every 12 weeks, in subjects with unresectable and/or metastatic well differentiated, typical or atypical lung neuroendocrine tumours. Clinical Trials.gov - NCT02683941
Randomized Phase II Study of Cisplatin and Etoposide Versus Temozolomide and Capecitabine in Patients With Advanced G3 Non-small Cell Gastroenteropancreatic Neuroendocrine Carcinomas
A multicenter, randomized phase II trial is comparing cisplatin plus etoposide with temozolomide plus capecitabine in patients with advanced, WHO grade 3 non-small cell gastroenteropancreatic neuroendocrine carcinomas (GEPNEC) (EA2142; NCT02595424). Poorly differentiated GEPNECs are a relatively poorly understood class of tumors that historically have been treated similarly to small cell lung cancer with platinum and etoposide, based on histologic similarities. However, emerging data indicate heterogeneity among grade 3 GEPNECs, suggesting that alternative treatments may be appropriate in certain cases. This study will be the first prospective trial comparing cisplatin plus etoposide with temozolomide plus capecitabine in G3 GEPNECs and correlating response with other clinical parameters. Clinical Trials.gov - NCT02595424