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Everolimus and Temozolomide in Advanced Gastroenteropancreatic Neuroendocrine Carcinoma (G3)

Primary Purpose

Neuroendocrine Carcinoma

Status
Completed
Phase
Phase 2
Locations
Norway
Study Type
Interventional
Intervention
Everolimus , temozolomide
Sponsored by
Haukeland University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuroendocrine Carcinoma focused on measuring Gastroenteropancreatic, Neuroendocrine carcinoma, Chemotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Haukeland University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Everolimus/temozolomide

Arm Description

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

Outcomes

Primary Outcome Measures

Disease control rate

Secondary Outcome Measures

Number of patients with adverse events
Especially number of patients with grade 3-4 toxicity.

Full Information

First Posted
July 24, 2014
Last Updated
December 18, 2019
Sponsor
Haukeland University Hospital
Collaborators
Skane University Hospital, Copenhagen University Hospital, Denmark, Rigshospitalet, Denmark, Uppsala University Hospital, Aarhus University Hospital, Sahlgrenska University Hospital, Sweden, Ullevaal University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02248012
Brief Title
Everolimus and Temozolomide in Advanced Gastroenteropancreatic Neuroendocrine Carcinoma (G3)
Official Title
Everolimus and Temozolomide as 1-line Treatment in Advanced Gastroenteropancreatic Neuroendocrine Carcinoma (G3) With a Ki67 of 20-55%
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
December 2014 (Actual)
Primary Completion Date
January 2018 (Actual)
Study Completion Date
December 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Haukeland University Hospital
Collaborators
Skane University Hospital, Copenhagen University Hospital, Denmark, Rigshospitalet, Denmark, Uppsala University Hospital, Aarhus University Hospital, Sahlgrenska University Hospital, Sweden, Ullevaal University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuroendocrine Carcinoma
Keywords
Gastroenteropancreatic, Neuroendocrine carcinoma, Chemotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Everolimus/temozolomide
Arm Type
Experimental
Arm Description
Everolimus 10 mg daily, temozolomide 150 mg/m2 for 7 days every 2 weeks.
Intervention Type
Drug
Intervention Name(s)
Everolimus , temozolomide
Primary Outcome Measure Information:
Title
Disease control rate
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Number of patients with adverse events
Description
Especially number of patients with grade 3-4 toxicity.
Time Frame
During treatment + 30 days
Other Pre-specified Outcome Measures:
Title
Time (months) from start of study treatment to death (survival)
Description
Patients alive at 18 months after last patient entered into the study will be censored.
Time Frame
Average 14 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Halfdan Sorbye, MD
Organizational Affiliation
Haukeland Univ Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Haukeland University Hospital
City
Bergen
ZIP/Postal Code
5021
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
24771552
Citation
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.
Results Reference
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Everolimus and Temozolomide in Advanced Gastroenteropancreatic Neuroendocrine Carcinoma (G3)

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