Status:
COMPLETED
Everolimus and Temozolomide in Advanced Gastroenteropancreatic Neuroendocrine Carcinoma (G3)
Lead Sponsor:
Haukeland University Hospital
Collaborating Sponsors:
Skane University Hospital
Copenhagen University Hospital, Denmark
Conditions:
Neuroendocrine Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ra...
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2019
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT02248012
Start Date
December 1 2014
End Date
December 1 2019
Last Update
December 19 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Haukeland University Hospital
Bergen, Norway, 5021