Everolimus and Temozolomide in Advanced Gastroenteropancreatic Neuroendocrine Carcinoma (G3)

Neuroendocrine Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02248012
• Other study ID #: 2013-002524-16
• Status: Completed
• Phase: Phase 2
• Start date: December 2014
• Est. completion date: December 1, 2019

Study information

• Verified date: December 2019
• Source: Haukeland University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: December 1, 2019
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Neuroendocrine
• Neuroendocrine Carcinoma

Intervention

Drug:
• Everolimus , temozolomide

Locations

Country	Name	City	State
Norway	Haukeland University Hospital	Bergen

Sponsors (8)

Lead Sponsor	Collaborator
Haukeland University Hospital	Aarhus University Hospital, Copenhagen University Hospital, Denmark, Rigshospitalet, Denmark, Sahlgrenska University Hospital, Sweden, Skane University Hospital, Ullevaal University Hospital, Uppsala University Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (1)

Sorbye H, Strosberg J, Baudin E, Klimstra DS, Yao JC. Gastroenteropancreatic high-grade neuroendocrine carcinoma. Cancer. 2014 Sep 15;120(18):2814-23. doi: 10.1002/cncr.28721. Epub 2014 Apr 25. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Time (months) from start of study treatment to death (survival)	Patients alive at 18 months after last patient entered into the study will be censored.	Average 14 months
Primary	Disease control rate		6 months
Secondary	Number of patients with adverse events	Especially number of patients with grade 3-4 toxicity.	During treatment + 30 days