evaluation of the activity of Everolimus as maintenance therapy for metastatic neuroendocrine carcinoma with pulmonary or gastroenteropancreatic origin.
- Conditions
- The aim of this study is to evaluate the activity of a maintenance therapy with everolimus 10 mg daily in patients with stable disease, partial response or complete response after 6 cycles of induction chemotherapy with cisplatin or carboplatin plus etoposide administered according to clinical practice.Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2014-003951-72-IT
- Lead Sponsor
- Gruppo Oncologico Italiano Ricerca Cancro (GOIRC)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Patients may be included in the study if they meet all of the following 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
•non functional NEC
•locally advanced inoperable or metastatic disease
•measurable or evaluable disease according to RECIST criteria (version 1.1)
•Age> 18;
•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 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10
•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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary endpoint is progression free survival (PFS) defined as <br> the time between randomization and the first evidence of progressive disease or date of death, whichever occurs first. Documentation of disease progression will be defined as per RECIST 1.1 criteria based on investigator assessment. The censoring date for a patient who is known to be progression-free would be the date of the last tumor assessment. <br>;Secondary Objective: Overall survival (OS) defined as the time from randomization to death from any cause<br>Safety profile: Safety of the treatment will be evaluated by serious and non serious adverse events (AEs). AEs will be graded according to the CTCAE v4.03<br>Evaluation of prognostic/predictive factors on tumoral tissue and blood samples of patients treated with maintenance Everolimus:;Primary end point(s): Progression free survival (PFS);Timepoint(s) of evaluation of this end point: 3 months
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Overall survival (OS), safety profile, evaluation of prognostic/predictive factors on tumoral tissue and blood samples <br>;Timepoint(s) of evaluation of this end point: 10 months for OS and during maintenace treatment for safety profile and <br>evaluation of prognostic/predictive factors on tumoral tissue and blood samples