Clinical Trial: Study of Everolimus as Maintenance Therapy for Metastatic NEC With Pulmonary or Gastroenteropancreatic Origin

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional




Official Title: Phase II Randomized Multicenter Study of Everolimus as Maintenance Therapy for Metastatic Neuroendocrine Carcinoma With Pulmonary or Gastroenteropancreatic Origin

Brief Summary:

Cisplatin and Etoposide is the standard of care in NEC originating from the gastro-intestinal tract and lung, based on retrospective studies.

Nevertheless the prognosis of this group of patients is still poor with median survival of less than 20 months.

Everolimus is an mammilian target of rapamycin (mTOR) inhibitor that has been demonstrated to be active in patients with well and moderately differentiated primitive neuroectodermal tumor (pNET).

Recently, the Investigators demonstrated that the mammilian target of rapamycin (mTOR) pathway is overexpressed in NEC.

Based on the activity of Everolimus in the treatment of patients with well and moderately differentiated p-NET and on the evidence that even poorly differentiated forms express the pathway of m-TOR is conceivable that Everolimus could be active even in NEC.