Clinical Trials Logo
  1. Home
  2. Neuroendocrine Carcinoma
  3. NCT02248012

Everolimus and Temozolomide in Advanced Gastroenteropancreatic Neuroendocrine Carcinoma (G3)

Neuroendocrine Carcinoma Clinical Trial

Official title:
Everolimus and Temozolomide as 1-line Treatment in Advanced Gastroenteropancreatic Neuroendocrine Carcinoma (G3) With a Ki67 of 20-55%

Clinical Trial 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02248012
Study type Interventional
Source Haukeland University Hospital
Contact
Status Completed
Phase Phase 2
Start date December 2014
Completion date December 1, 2019
View Details
See also
  Status Clinical Trial Phase
Completed NCT01642251 - Cisplatin and Etoposide With or Without Veliparib in Treating Patients With Extensive Stage Small Cell Lung Cancer Phase 1/Phase 2
Recruiting NCT04069299 - Use of 68Ga-dotatate PET Scan in Neuroendocrine Carcinoma of the GI Tract
Recruiting NCT04464122 - Rediscovering Biomarkers for the Diagnosis and Early Treatment Response in NEN (REBORN)
Recruiting NCT04325425 - Chemotherapy For Metastatic Grade 3 Poorly Differentiated NEuroendocrine Carcinoma Of GastroEnteroPancreatic And Unknown Primary Phase 2
Completed NCT03834701 - Endoscopic Ultrasound-guided RadioFrequency Ablation for the Treatment Pancreatic NeuroEndocrine Neoplasms N/A
Recruiting NCT03279614 - Study to Evaluate the Efficiency of SOX as Seconde-line Chemotherapy in Neuroendocrine Carcinoma Phase 2
Recruiting NCT05978284 - Study of ZG006 in Participants With Small Cell Lung Cancer or Neuroendocrine Carcinoma Phase 1/Phase 2
Recruiting NCT05076786 - Chidamide Plus Etoposide and Cisplatin/Carboplatin as First-line Treatment for Extrapulmonary Neuroendocrine Carcinoma Phase 2
Completed NCT00388063 - Safety and Efficacy of Atiprimod Treatment for Patients With Low to Intermediate Grade Neuroendocrine Carcinoma Phase 2
Withdrawn NCT03901378 - Pembrolizumab With Chemotherapy in Metastatic or Unresectable High Grade Gastroenteropancreatic or Lung Neuroendocrine Carcinoma Phase 2
Recruiting NCT02970786 - Phase I Trial: 68Ga-NODAGA-E(c[RGDyK])2 Positron Emission Tomography for Imaging Angiogenesis in Primary and Metastatic Tumor Lesions in Humans Phase 1
Completed NCT00663429 - Extension Study of the Safety and Efficacy of Atiprimod Treatment in Neuroendocrine Carcinoma Phase 2
Recruiting NCT05113355 - Chidamide Plus Sintilimab for Chemotherapy-refractory Advanced High-grade Neuroendocrine Neoplasm Phase 2
Completed NCT03278405 - Avelumab in G3 NEC Phase 1/Phase 2
Active, not recruiting NCT03837977 - Second-line Therapy for Patients With Progressive Poorly Differentiated Extra-pulmonary Neuroendocrine Carcinoma Phase 2
Recruiting NCT06372626 - Study of ZG005 in Combination With Etoposide and Cisplatin in Participants With Advanced Neuroendocrine Carcinoma. Phase 1/Phase 2
Not yet recruiting NCT06333314 - Dostarlimab for Locally Advanced or Metastatic Cancer (Non-colorectal/Non-endometrial) With Tumor dMMR/MSI Phase 2
Active, not recruiting NCT02687958 - Study of Everolimus as Maintenance Therapy for Metastatic NEC With Pulmonary or Gastroenteropancreatic Origin Phase 2
Completed NCT01121939 - Combination of Bevacizumab, Pertuzumab, and Sandostatin for Adv. Neuroendocrine Cancers Phase 2
Recruiting NCT03168607 - Study to Evaluate the Efficiency of FOLFIRI as Seconde-line Chemotherapy in Neuroendocrine Carcinoma Phase 2