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Trial record 1 of 3 for:    halfdan Sorbye
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Everolimus and Temozolomide in Advanced Gastroenteropancreatic Neuroendocrine Carcinoma (G3)

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ClinicalTrials.gov Identifier: NCT02248012
Recruitment Status : Completed
First Posted : September 25, 2014
Last Update Posted : December 19, 2019
Sponsor:
Collaborators:
Skane University Hospital
Copenhagen University Hospital, Denmark
Rigshospitalet, Denmark
Uppsala University Hospital
Aarhus University Hospital
Sahlgrenska University Hospital, Sweden
Ullevaal University Hospital
Information provided by (Responsible Party):
Haukeland University Hospital

Study Description
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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
Neuroendocrine Carcinoma Drug: Everolimus , temozolomide 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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Everolimus and Temozolomide as 1-line Treatment in Advanced Gastroenteropancreatic Neuroendocrine Carcinoma (G3) With a Ki67 of 20-55%
Actual Study Start Date : December 2014
Actual Primary Completion Date : January 2018
Actual Study Completion Date : December 1, 2019

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Arms and Interventions
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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
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Primary Outcome Measures :
  1. Disease control rate [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Number of patients with adverse events [ Time Frame: During treatment + 30 days ]
    Especially number of patients with grade 3-4 toxicity.


Other Outcome Measures:
  1. Time (months) from start of study treatment to death (survival) [ Time Frame: Average 14 months ]
    Patients alive at 18 months after last patient entered into the study will be censored.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02248012


Locations
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Norway
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
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Principal Investigator: Halfdan Sorbye, MD Haukeland Univ Hospital
More Information
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Publications:

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Responsible Party: Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT02248012    
Other Study ID Numbers: 2013-002524-16
First Posted: September 25, 2014    Key Record Dates
Last Update Posted: December 19, 2019
Last Verified: December 2019
Keywords provided by Haukeland University Hospital:
Gastroenteropancreatic
Neuroendocrine carcinoma
Chemotherapy
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Neuroendocrine
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Adenocarcinoma
Neoplasms, Nerve Tissue
 Everolimus
Temozolomide
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action