Everolimus and Temozolomide in Advanced Gastroenteropancreatic Neuroendocrine Carcinoma (G3)

• Status: Completed
• Trial end date: 2019-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Haukeland University Hospital
• Collaborators: Aarhus University Hospital; Copenhagen University Hospital, Denmark; Rigshospitalet, Denmark; Sahlgrenska University Hospital, Sweden; Skane University Hospital; Ullevaal University Hospital; Uppsala University Hospital
• Treatments: Dacarbazine; Everolimus; Sirolimus; Temozolomide

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.