Everolimus and Temozolomide in Advanced Gastroenteropancreatic Neuroendocrine Carcinoma (G3)
Study Details
Study Description
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 rate (non-progressive disease) at 6 months.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
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
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Everolimus/temozolomide Everolimus 10 mg daily, temozolomide 150 mg/m2 for 7 days every 2 weeks. |
Drug: Everolimus , temozolomide
|
Outcome Measures
Primary Outcome Measures
- Disease control rate [6 months]
Secondary Outcome Measures
- Number of patients with adverse events [During treatment + 30 days]
Especially number of patients with grade 3-4 toxicity.
Other Outcome Measures
- Time (months) from start of study treatment to death (survival) [Average 14 months]
Patients alive at 18 months after last patient entered into the study will be censored.
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Haukeland University Hospital | Bergen | Norway | 5021 |
Sponsors and Collaborators
- Haukeland University Hospital
- Skane University Hospital
- Copenhagen University Hospital, Denmark
- Rigshospitalet, Denmark
- Uppsala University Hospital
- Aarhus University Hospital
- Sahlgrenska University Hospital, Sweden
- Ullevaal University Hospital
Investigators
- Principal Investigator: Halfdan Sorbye, MD, Haukeland Univ Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
- 2013-002524-16