Everolimus and Temozolomide in Advanced Gastroenteropancreatic Neuroendocrine Carcinoma (G3)
Conditions
Neuroendocrine Carcinoma
Conditions: official terms
Carcinoma - Carcinoma, Neuroendocrine
Conditions: Keywords
Gastroenteropancreatic, Neuroendocrine carcinoma, Chemotherapy
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Everolimus , temozolomide
Type: Drug
Overall Status
Recruiting
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
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: 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.
Location
Haukeland University Hospital
Bergen, Norway
Status: Recruiting
Contact: Halfdan Sorbye, Prof - halfdan.sorbye@helse-bergen.no
Start Date
December 2014
Completion Date
December 2018
Sponsors
Haukeland University Hospital
Source
Haukeland University Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page