UnknownPhase 2

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

Italy30 participantsStarted 2015-05

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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, cerebrovasc…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

PFS

Timeframe: 24 months

Trial details

NCT IDNCT02687958

SponsorGruppo Oncologico Italiano di Ricerca Clinica

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-12

View on ClinicalTrials.gov More Neuroendocrine Carcinoma trials