Everolimus and Temozolomide in Advanced Gastroenteropancreatic Neuroendocrine Carcinoma (G3)

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02248012

Enrollment

Registered

2014-09-25

Start date

2014-12-31

Completion date

2019-12-01

Last updated

2019-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuroendocrine Carcinoma

Keywords

Gastroenteropancreatic, Neuroendocrine carcinoma, Chemotherapy

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

Interventions

DRUGEverolimus , temozolomide

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Histologically proven neuroendocrine carcinoma with a Ki67 of 20-55%.Primary gastroenteropancreatic tumor or cancer of unknown primary where metastases are mainly abdominalMeasurable disease according to RECIST by CT/MR General conditions: * \>18 years; * WHO/ECOG performance status 0-1. * Adequate haematological, renal and hepatic functions: * Written informed consent prior to inclusion Prior therapy: * No prior chemotherapy treatment for advanced disease. * Adjuvant chemotherapy must have ended \> 6 months before inclusion. Prior or current history: * No curatively resectable disease; * No other serious illness or medical conditions (including: unstable angina, myocardial infarction within 6 months, unstable diabetes, immune suppression ) Concomitant treatments : * No concomitant (or within 4 weeks before inclusion) administration of any other experimental drug; * No other concurrent anti-cancer therapy. Other : * Not pregnant or breast feeding. Fertile patients must use adequate contraceptives and fertile females must have a negative pregnancy test.

Design outcomes

Primary

Measure	Time frame
Disease control rate	6 months

Secondary

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

Other

Measure	Time frame	Description
Time (months) from start of study treatment to death (survival)	Average 14 months	Patients alive at 18 months after last patient entered into the study will be censored.

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026