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Study of Everolimus as Maintenance Therapy for Metastatic NEC With Pulmonary or Gastroenteropancreatic Origin

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ClinicalTrials.gov Identifier: NCT02687958
Recruitment Status : Recruiting
First Posted : February 22, 2016
Last Update Posted : February 8, 2017
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Gruppo Oncologico Italiano di Ricerca Clinica

Brief Summary:

Cisplatin and Etoposide is the standard of care in NEC originating from the gastro-intestinal tract and lung, based on retrospective studies.

Nevertheless the prognosis of this group of patients is still poor with median survival of less than 20 months.

Everolimus is an mammilian target of rapamycin (mTOR) inhibitor that has been demonstrated to be active in patients with well and moderately differentiated primitive neuroectodermal tumor (pNET).

Recently, the Investigators demonstrated that the mammilian target of rapamycin (mTOR) pathway is overexpressed in NEC.

Based on the activity of Everolimus in the treatment of patients with well and moderately differentiated p-NET and on the evidence that even poorly differentiated forms express the pathway of m-TOR is conceivable that Everolimus could be active even in NEC.


Condition or disease Intervention/treatment Phase
Neuroendocrine Carcinoma Drug: Everolimus Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Randomized Multicenter Study of Everolimus as Maintenance Therapy for Metastatic Neuroendocrine Carcinoma With Pulmonary or Gastroenteropancreatic Origin
Study Start Date : May 2015
Actual Primary Completion Date : January 2017
Estimated Study Completion Date : May 2017


Arm Intervention/treatment
Experimental: A Everolimus 10mg (every cycle) until PD
Patients with stable disease, partial response or complete response after 4- 6 cycles of induction chemotherapy with Cisplatin or Carboplatin plus Etoposide or alternative first line chemotherapy according with local practice will receive maintenance therapy with Everolimus 10mg every cycle (28days) until PD or unacceptable toxicity.
Drug: Everolimus
Maintenance therapy
Other Name: Afinitor
No Intervention: B Observational
Patients in this arm will meet observation criteria



Primary Outcome Measures :
  1. PFS [ Time Frame: 24 months ]
    progression free survival (PFS)


Secondary Outcome Measures :
  1. OS [ Time Frame: 24 months ]
    Overall survival (OS)

  2. ctDNA [ Time Frame: 24 months ]
    circulating DNA



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histological / cytological diagnosis of GEP Neuroendocrine Carcinoma (NEC) with Ki67< 55% (WHO 2010)
  • Histological/cytological diagnosis of large-cells neuroendocrine carcinoma of the lung with Ki67 <55%;
  • Stable disease, partial response or complete response (Recist 1.1) after 6 cycles of first line chemotherapy with Cisplatin plus Etoposide or alternative first line chemotherapy according with local practice
  • non functional NEC
  • locally advanced inoperable or metastatic disease
  • measurable or evaluable disease according to RECIST criteria (version 1.1)
  • Age> 18;
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2;
  • Adequate bone marrow function (Hb> 9.0 g / dL, absolute neutrophil count> 1.5 x 109 / L, platelets> 100 x 109 / L), renal function (serum creatinine <2 mg / dL x upper limit of normal (ULN) or creatinine clearance, Cockroft formula, ≥ 30 ml / min), hepatic function (serum bilirubin <1.5 x ULN, serum transaminases <2.5 x ULN in the absence of liver metastases or <5x ULN in the presence of liver metastases);
  • Negative pregnancy test or breastfeeding women during childbearing age;
  • Written informed consent;
  • Approval of the Ethics Committee that will be required.

Exclusion Criteria:

  • clinically significant cardiovascular disorders in the 6 months prior to randomization (congestive heart failure, myocardial infarction, unstable angina, severe uncontrolled cardiac arrhythmia, arterial thrombosis, cerebrovascular accidents, pulmonary thromboembolism);
  • Functional Neuroendocrine Carcinoma NEC
  • Neuroendocrine carcinoma with ki 67 > 55%
  • ongoing uncontrolled infection;
  • Concomitant intake of:

    • Drugs incompatible with concomitant everolimus;
    • Any other drug in clinical trials;
  • History of other malignancy except carcinoma in situ of the cervix or basal / squamous cell carcinoma of the skin adequately treated;
  • Presence of brain metastases;
  • Any other serious or uncontrolled concurrent disease conditions that the safe administration of medications

Information from the National Library of Medicine

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): NCT02687958


Contacts
Contact: Luisa Di Cerbo, SC +390557947298 luisa.dicerbo@libero.it
Contact: Alessandro Di Costanzo, SC +390557947298 adicostanzo.oncmed@hotmail.com

Locations
Italy
S.C. Oncologia - Policlinico Active, not recruiting
Modena, Emilia - Romagna, Italy, 41124
U.O. Oncologia Medica 1 - AOU Pisana Recruiting
Pisa, Tuscany, Italy, 56126
Contact: Cinzia Orlandini, SC         
Principal Investigator: Sergio Ricci, MD         
Azienda Ospedaliera "Spedali Civili di Brescia" Active, not recruiting
Brescia, Italy, 25123
Azienda Ospedaliera Universitaria Careggi Recruiting
Florence, Italy, 50134
Contact: Luisa Di Cerbo, SC    +390557947298    luisa.dicerbo@libero.it   
Contact: Alessandro Di Costanzo, SC    +390557947298    adicostanzo.oncmed@hotmail.com   
Principal Investigator: Francesco Di Costanzo, MD         
Principal Investigator: Lorenzo Antonuzzo, MD         
Istituto Europeo di Oncologia Active, not recruiting
Milano, Italy, 20141
Sponsors and Collaborators
Gruppo Oncologico Italiano di Ricerca Clinica
Novartis
Investigators
Principal Investigator: Francesco Di Costanzo, MD AOU Careggi
Principal Investigator: Lorenzo Antonuzzo, MD AOU Careggi

Responsible Party: Gruppo Oncologico Italiano di Ricerca Clinica
ClinicalTrials.gov Identifier: NCT02687958     History of Changes
Other Study ID Numbers: GOIRC 02/2014
First Posted: February 22, 2016    Key Record Dates
Last Update Posted: February 8, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Gruppo Oncologico Italiano di Ricerca Clinica:
GEP/ NEC

Additional relevant MeSH terms:
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
Sirolimus
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents