Clinical trial NCT02075606: Circulating Tumour Cells in Somatuline Autogel Treated NeuroEndocrine Tumours Patients
Official title: A Phase IV, Multicentre, Open Label, Single Group Exploratory Study to Assess the Clinical Value of Enumeration of Circulating Tumour Cells (CTCs) to Predict Clinical Symptomatic Response and Progression Free Survival in Patients Receiving Deep Subcutaneous Administrations of Somatuline® (Lanreotide) Autogel® to Treat the Symptoms of Functioning Midgut NeuroEndocrine Tumours (NET)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: NeuroEndocrine Tumours
Keywords: NET
Symptomatic response
Functioning NeuroEndocrine Tumours
midgut region
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2014-03-03
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Circulating tumour cells (CTCs) are detectable in the blood in around 50% of patients with functioning NeuroEndocrine Tumours (NET) arising in the midgut area (tumours which are secreting hormones and are located in the area in the middle of the digestive system) and their presence usually means that the prognosis for the patient is poor. CTCs have also been shown to be valuable as predictive markers following treatment and there is increasing interest in using CTCs as 'liquid biopsies' that can help to inform treatment decisions. CTC analysis has the benefit of being relatively non- invasive and quick compared with a conventional CT scan and is therefore an attractive method of monitoring the tumour throughout the treatment period.

The purpose of this study is to assess the clinical value that enumeration will have in predicting the clinical symptomatic response and progression free survival in patients receiving Somatuline Autogel for functioning midgut NETs over a one year period.


Eligibility criteria: Inclusion Criteria:

* Provision of written informed consent prior to any study related procedures.
* Patients (either sex) must be 18 years or older.
* Patients must be suffering from symptoms of diarrhoea and/or flushing at the time of study enrolment.
* Patients must have a documented diagnosis of a functioning midgut NET.
* In order to avoid patients with rapidly progressing tumours, only patients with well or moderately differentiated tumours and with a Ki67 proliferation index of \<20% will be recruited.
* The clinically appropriate treatment for the patient must be therapy with a somatostatin analogue.
* Patients must have had either a positive somatostatin receptor scintigraphy result or a positive 68Gallium-DOTATATE PET imaging result.

Exclusion Criteria:

* If the patient is at risk of pregnancy or is breast feeding, unless treatment with Somatuline Autogel is clearly needed (as determined by the clinician).
* The patient is, in the opinion of the investigator, unable to comply fully with the protocol and the study instructions, or present any concomitant condition which could compromise the objectives of the study and/or preclude the protocol-defined procedures (e.g. severe medical conditions, brain metastases, psychiatric disorders, active or uncontrolled infection, known pituitary disease).
* The patient has been treated with any other unlicensed drug within the last 30 days before study entry or will require a concurrent treatment with any other experimental drugs or treatments.
* The patient has been treated with a somatostatin analogue prior to study entry, unless a washout period of at least 2 weeks for subcutaneous octreotide, or at least 6 weeks for a single dose of long acting somatostatin analogue has occurred.
* The patient has received interferon, chemotherapy, chemoembolisation or radionuclide therapy within 3 months prior to study entry.
* The patient has a history of hypersensitivity to drugs with a similar chemical structure.
* Females of childbearing potential must be using oral, double barrier or injectable contraception. Non childbearing potential is defined as being post-menopause for at least 1 year, surgical sterilisation or hysterectomy at least three months before the start of the study.
* The patient has abnormal baseline findings, any other medical condition(s) or laboratory findings that, in the opinion of the Investigator, might jeopardise the patient's safety or decrease the chance of obtaining satisfactory data needed to achieve the objective(s) of the study.

Primary outcomes:
measure: Assessment of Clinical Symptomatic Response
timeFrame: From baseline up to Week 53.
measure: Percentage of Subjects With Time Point Responses According to Response Evaluation Criteria in Solid Tumours (RECIST) Assessments at Weeks 25 and 53
timeFrame: Week 25 and Week 53.
Secondary outcomes:
measure: Mean Change From Baseline in Number of Episodes of Diarrhoea and Flushing
timeFrame: From baseline up to Week 53.
measure: Mode Symptom Severity of Episodes of Flushing
timeFrame: From baseline up to Week 53.
measure: Quality of Life (QoL) Questionnaire: European Organisation for Research and Treatment of Cancer (EORTC) QoL Questionnaire (QLQ)-C30
timeFrame: From baseline up to Week 53.
measure: QoL Questionnaire: EORTC QLQ-G.I.NET21
timeFrame: From baseline up to Week 53.
measure: Percentage of Subjects Alive and Progression Free at One Year
timeFrame: From baseline up to Week 53.
Other outcomes:
Locations:
city: Basingstoke
country: United Kingdom
facility: Basingstoke & North Hampshire Hospital
city: Birmingham
country: United Kingdom
facility: Queen Elizabeth Hospital
city: Cardiff
country: United Kingdom
facility: University Hospital Wales
city: Glasgow
country: United Kingdom
facility: Beatson West of Scotland Cancer Centre
city: Leeds
country: United Kingdom
facility: St James's University Hospital
city: Liverpool
country: United Kingdom
facility: University Hospital Aintree
city: London
country: United Kingdom
facility: Hammersmith Hospital
city: London
country: United Kingdom
facility: King's College Hospital
city: London
country: United Kingdom
facility: Royal Free Hospital
city: Maidstone
country: United Kingdom
facility: Maidstone Hospital
city: Manchester
country: United Kingdom
facility: The Christie Hospital
city: Norwich
country: United Kingdom
facility: Norfolk & Norwich Hospital
city: Sheffield
country: United Kingdom
facility: Royal Hallamshire Hospital
city: Southampton
country: United Kingdom
facility: Southampton University Hospital
Study officials:
affiliation: Ipsen
name: Matthew Hickling, MD
role: STUDY_DIRECTOR
References:
citation: Meyer T, Caplin M, Khan MS, Toumpanakis C, Shetty S, Ramage JK, Houchard A, Higgs K, Shah T. Circulating tumour cells and tumour biomarkers in functional midgut neuroendocrine tumours. J Neuroendocrinol. 2022 Apr;34(4):e13096. doi: 10.1111/jne.13096. Epub 2022 Feb 7.
citation: Childs A, Vesely C, Ensell L, Lowe H, Luong TV, Caplin ME, Toumpanakis C, Thirlwell C, Hartley JA, Meyer T. Expression of somatostatin receptors 2 and 5 in circulating tumour cells from patients with neuroendocrine tumours. Br J Cancer. 2016 Dec 6;115(12):1540-1547. doi: 10.1038/bjc.2016.377. Epub 2016 Nov 22.