Everolimus and Temozolomide in Advanced Gastroenteropancreatic Neuroendocrine Carcinoma (G3)

Haukeland University Hospital

Status and phase: Completed; Phase 2

Conditions: Neuroendocrine Carcinoma

Treatments: Drug: Everolimus , temozolomide

Study type: Interventional

Funder types: Other

Identifiers

NCT02248012

2013-002524-16

Details and patient eligibility

About

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.

Full 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

Enrollment: 38 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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38 participants in 1 patient group

Everolimus/temozolomide

Experimental group

Description:

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

Treatment:

Drug: Everolimus , temozolomide