Everolimus and Temozolomide in Advanced Gastroenteropancreatic Neuroendocrine Carcinoma (G3)

Phase 2

Completed

• Conditions: Neuroendocrine Carcinoma
• Interventions: Drug: Everolimus , temozolomide

• Registration Number: NCT02248012
• Lead Sponsor: Haukeland University Hospital

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 Description

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

Study Timeline

• Study First Submitted: 2014-07-24
• Study First Submitted QC: 2014-09-19
• Study First Posted: 2014-09-25
• Study Start: 2014-12
• Primary Completion: 2018-01
• Status Verified: 2019-12
• Study Completion: 2019-12-01
• Last Update Submitted: 2019-12-18
• Last Update Posted: 2019-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Everolimus/temozolomide	Everolimus , temozolomide	Everolimus 10 mg daily, temozolomide 150 mg/m2 for 7 days every 2 weeks.

Primary Outcome Measures

Name	Time	Method
Disease control rate	6 months

Secondary Outcome Measures

Name	Time	Method
Number of patients with adverse events	During treatment + 30 days	Especially number of patients with grade 3-4 toxicity.

Trial Locations

Locations (1)

Haukeland University Hospital; 🇳🇴 Bergen, Norway