Phase II randomized multicenter study of Everolimus as maintenance therapy for metastatic neuroendocrine carcinoma with pulmonary or gastroenteropancreatic origin. - MAVERIC

Gruppo Oncologico Italiano Ricerca Cancro (GOIRC)0 个研究点开始时间: 2015年1月15日最近更新: 2015年10月12日

适应症

试验速览

暂无简介。

•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)
•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

发起方

Gruppo Oncologico Italiano Ricerca Cancro (GOIRC)