An Italian multicenter trial with Temozolomide taken daily at low doses continuously in patients with well differentiated neuroendocrine neoplasia (NENs) and in a clinical frailty status
- Conditions
- Patients with well differentiated neuroendocrine neoplasia (NENs) not eligible for active antitumoral treatments due to their clinical conditions.MedDRA version: 20.0Level: PTClassification code 10057270Term: Neuroendocrine carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2020-005393-10-IT
- Lead Sponsor
- ISTITUTO EUROPEO DI ONCOLOGIA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 46
• Age > 18 years;
• Histologically proven diagnosis of low grade GEP-NENs (in accordance with WHO 2019 classification), bronchial carcinoids (in accordance with the Travis classification), low grade of unknown primary sites NENs;
• Advanced disease (unresectable locally advanced or metastatic);
• ECOG performance status 2 and/or moderate medullary impairment (Hb concentration <10-8 gr/dl; WBC <3000-2000/mm3; platelets <75000-50000/mm3; neutrophil count <1500- 1000/mm3); renal failure (eGFR o CrCl 30-59 ml/min – G2) and/or moderate liver failure (Child B 7-9) and/or severe comorbidities and/or > 3 prior systemic antitumor therapies (apart from SSA);
• Functioning/non functioning;
• Morphological progressive disease (CT scan or MRI);
• Clinical progression (as judged by the investigator).
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 26
• Patients pretreated with Temozolomide
• Are Women of Child-Bearing Potential (WOCBP) and men who are able to father a child, unwilling to use adequate contraception prior to trial entry, for the duration of trial participation and for at least 28 days 2 weeks after treatment has ended. Adequate methods of contraception and Women of Child-Bearing Potential; WOCBP childbearing potential who are nursing or are pregnant or do not agree to submit to pregnancy testing required by this protocol
• Patients that did not sign written informed consent prior to admission into the trial that is consistent with International Conference on Harmonisation (ICH)- Good Clinical Practice (GCP) guidelines and local law
• Known active hepatitis B infection (defined as presence of Hepatitis B (HepB) sAg and/or HepB DNA), active Hepatitis C (HEP C) infection (defined as presence of Hep C RNA) and/or known Human Immunodeficiency Virus (HIV) carrier.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Progression free survival (PFS).;Secondary Objective: • Objective response rate (ORR) that means complete response (CR) + partial response (PR) in progressive, metastatic, low grade NENs.<br>• Duration of response.<br>• Overall survival (OS).<br>• Safety.<br>• Quality of life (QoL)<br>• Centralized evaluation of O6-methylguanine-DNA-methyltransferase (MGMT) status in tumor tissue to correlate clinical outcomes and MGMT status and validate the method of MGMT determination.;Primary end point(s): • Progression free survival (PFS);Timepoint(s) of evaluation of this end point: Every month during treatment period, every 3 months for the first 1 year after the end of the treatment, and then every 6 months for 1 year.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): • Objective response rate (ORR) that means complete response (CR) + partial response (PR) in<br>progressive, metastatic, low grade NENs.<br>• Duration of response.<br>• Overall survival (OS).<br>• Safety.<br>• Quality of life (QoL)<br>• Centralized evaluation of O6-methylguanine-DNA-methyltransferase (MGMT) status in tumor tissue to correlate clinical outcomes and MGMT status and validate the method of MGMT determination;Timepoint(s) of evaluation of this end point: Every month during treatment period, every 3 months for the first 1 year after the end of the treatment, and then every 6 months for 1 year.