Clinical Trial: Everolimus and Temozolomide in Advanced Gastroenteropancreatic Neuroendocrine Carcinoma (G3)

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

Official Title: Everolimus and Temozolomide as 1-line Treatment in Advanced Gastroenteropancreatic Neuroendocrine Carcinoma (G3) With a Ki67 of 20-55%

Brief Summary: To study the efficacy of everolimus combined with temozolomide as first-line treatment in advanced gastroenteropancreatic neuroendocrine carcinoma with a Ki67 of 20-55%, measured as disease control rate (non-progressive disease) at 6 months.

Detailed Summary: Guidelines for treating advanced gastroenteropancreatic neuroendocrine carcinomas (GEP-NECs) advocate the use of combination chemotherapy with a platinum-based chemotherapy combined with etoposide. No other regimen has consistently shown a benefit over this combination. NECs do not respond to treatments usually applied in other neuroendocrine tumours such as somatostatin analogues and interferon. In contrast to metastatic neuroendocrine tumours with a low Ki67, debulking surgery and surgery for liver metastasis is generally not recommended. Cisplatin /carboplatin and etoposide is established as standard treatment of advanced disease based on two small retrospective studies showing a response rate between 41- 67% and median survival of 15-19 months. In the current trial we propose an alternative treatment for a subgroup of patients with GEP-NEC based on new data, with the intention to improve response rates and clinical benefit rate without increasing toxicity
Sponsor: Haukeland University Hospital

Current Primary Outcome: Disease control rate [ Time Frame: 6 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Number of patients with adverse events [ Time Frame: During treatment + 30 days ]

Especially number of patients with grade 3-4 toxicity.


Original Secondary Outcome: Same as current

Information By: Haukeland University Hospital

Dates:
Date Received: July 24, 2014
Date Started: December 2014
Date Completion: December 2018
Last Updated: August 16, 2016
Last Verified: August 2016