Clinical Trial: Cisplatinum and Everolimus in Patients With Metastatic or Unresectable NEC of Extrapulmonary Origin

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Phase II Study of Cisplatinum and Everolimus in Patients With Metastatic or Unresectable Neuroendocrine Carcinomas (NEC) of Extrapulmonary Origin

Brief Summary: Phase II, open-label, multicentre national study. Patients with metastatic neuroendocrine carcinomas of extrapulmonary origin will be eligible. Treatment will be performed as indicated in the section "Investigational drug and reference therapy". Cisplatinum and everolimus dosing is based upon earlier phase 1 studies (Fury et al. 2012). CTs will be done at 9 weekly intervals (after 3 courses of chemotherapy;). Patients will be treated until documented progression according to RECIST 1.1. Enrolment is expected to take between 14 - 16 months. The total study duration is estimated to be 2 to 3 years until publication. Three NET centres in The Netherlands will participate, (Erasmus Medical Center in Rotterdam, Netherlands Cancer Institute in Amsterdam and , the University Medical Center of Groningen) A pre-treatment (and optional post-treatment) tumour biopsy will be included for DNA/RNA analyses and organoid culture. An additional 5cc of blood will be withdrawn as a germline DNA reference. A second 5 cc of blood will be included for measuring circulating tumour transcripts to identify all types of GEP-NET (NETTest).

Detailed Summary:
Sponsor: The Netherlands Cancer Institute

Current Primary Outcome: disease control rate [ Time Frame: every 9 weeks until up to 16 months ]

patients having a complete response, partial response or stable disease are considered successes


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • time to relapse [ Time Frame: From date of registration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months ]
  • overall survival [ Time Frame: Time from registration until the date of death from any cause, assessed up to 60 months ]
  • Effect on the markers chromogranin A (CgA) and neuron-specific enolase (NSE); [ Time Frame: from registration in the study markers will be taken every cycle until a maximum of 6 cycles is reached (cycle is every 3 weeks), until a maximum of 18 weeks. ]
  • Safety of everolimus in combination with cisplatin (AEs according to CTCAE v4.0) [ Time Frame: up to 30 days after end of treatment ]
    Number of participants with treatment-related adverse events as assessed by CTCAE v4.0


Original Secondary Outcome: Same as current

Information By: The Netherlands Cancer Institute

Dates:
Date Received: February 18, 2016
Date Started: March 2016
Date Completion: January 2018
Last Updated: January 11, 2017
Last Verified: January 2017