Clinical trial NCT00353496: Study of Lanreotide Autogel in Non-functioning Entero-pancreatic Endocrine Tumours
Official title: Phase III, Randomised, Double-blind, Stratified Comparative, Placebo Controlled, Parallel Group, Multi-centre Study to Assess the Effect of Deep Subcutaneous Injections of Lanreotide Autogel 120mg Administered Every 28 Days on Tumour Progression Free Survival in Patients With Non-functioning Entero-pancreatic Endocrine Tumour
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Endocrine Tumors
Keywords: Non functioning entero-pancreatic tumours
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2006-07-18
Enrollment: 264
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will compare the difference between lanreotide Autogel and placebo on progression free survival in patients who have an endocrine tumour in the pancreas or intestines.


Eligibility criteria: Inclusion Criteria:

* Endocrine tumour in the intestine or pancreas and with locally advanced or metastatic disease
* No hormone related symptoms
* Well or moderately differentiated tumour confirmed by histology
* Tumour lesions which are measurable by a CT or MRI scan

Exclusion Criteria:

* Previously treated with a somatostatin analogue unless more than 6 months ago and given for no more than 15 days
* Treated within the last 6 months with interferon, chemoembolisation or chemotherapy or at any time with a radionuclide
* Had a previous cancer except basal cell carcinoma and/or in situ carcinoma of the cervix/uterus and/or patients treated with curative intent and free from disease for 5 years
* Pregnant or lactating
* Females must use adequate contraception during the study

Primary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: From randomisation up to the last tumour assessment (scheduled at 96 weeks). Radiological scans were performed every 12 weeks during the first year and every 24 weeks during the second year
Secondary outcomes:
measure: Percentage of Patients Alive & Without Disease Progression
timeFrame: Week 48 & 96
measure: Pharmacokinetic Profile of Lanreotide
timeFrame: Week 4, 12, 24, 36, 48, 72, 96
measure: Change in the Global Health Status Quality of Life Assessment
timeFrame: Week 12 to Week 96 (last visit)
measure: Percentage of Patients With a Greater Than or Equal to 50% Decrease in Plasma Chromogranin A (CgA) Levels
timeFrame: Week 12 to Week 96 (last visit)
measure: Percentage of Patients Still Alive Based on Available Overall Survival Data
timeFrame: Randomisation to death or last visit, up to 321 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Outpatient Cancer Center
state: California
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Baltimore
country: United States
facility: The John Hopkins Hospital
state: Maryland
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
city: Portland
country: United States
facility: Providence Portland Medical Center
state: Oregon
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Madison
country: United States
facility: University of Wisconsin School of Medicine and Public Health
state: Wisconsin
city: Vienna
country: Austria
facility: University Hospital
city: Antwerpen
country: Belgium
facility: UZ Antwerpen
city: Bruxelles
country: Belgium
facility: UCL Saint Luc
city: Gent
country: Belgium
facility: UZ Gent
city: Bulovce
country: Czechia
facility: Fakultni nemocnice Na
state: Prague
city: Olomouc
country: Czechia
facility: Fekultni nemocnice Olomouc
city: Praha
country: Czechia
facility: General faculty
city: Aarhus
country: Denmark
facility: Sygehus Hospital
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Boulogne Billancourt
country: France
facility: Hôpital A. Paré
city: Clichy
country: France
facility: Hôpital Beaujon
city: Lille
country: France
facility: CAC Oscar Lambret
city: Lyon
country: France
facility: Hôpital Edouard Herriot
city: Marseille
country: France
facility: CHU la Timone
city: Reims
country: France
facility: Hôpital R. Debré
city: St Raphael
country: France
facility: CHI Frejus St Raphael
city: Toulouse
country: France
facility: Hôpital Rangueil
city: Villejuif
country: France
facility: Unité de gastro enterologie IGR
city: Berlin
country: Germany
facility: Charite Hospital
city: Erlangen
country: Germany
facility: University Hospital
city: Lubeck
country: Germany
facility: University Hospital
city: Mainz
country: Germany
facility: Gutenberg University Hospital
city: Munchen
country: Germany
facility: University Hospital
city: Neuss
country: Germany
facility: Lukas Hospital
city: Hyderabad
country: India
facility: Global Hospital
city: Mumbai
country: India
facility: Tata Memorial Hospital
city: Aviano
country: Italy
facility: Centro di Refierimiento Oncologica
city: Bologna
country: Italy
facility: Azienda Malpighi
city: Milano
country: Italy
facility: INSCT
city: Naples
country: Italy
facility: University of Naples
city: Pisa
country: Italy
facility: Hospital S. Chiara
city: Torino
country: Italy
facility: Azienda San Giovanni Battista
city: Gronigen
country: Netherlands
facility: UMC Gronigen
city: Rotterdam
country: Netherlands
facility: Erasmu MC
city: Utrecht
country: Netherlands
facility: UMC Utrecht
city: Gliwice
country: Poland
facility: Centrum Onkologii-Instytut im. Marii Sklodowskiej - Curie, oddzial w Gliwicach, Zaklad Medycyny Nuklearnej i Endokrynologii Onkologicznej ul.
city: Poznan
country: Poland
facility: Katedra i Klinika Endokrynologii Przemiany Materii i Chorob Wewnetrznych Uniwersytetu Medycznego w Poznaniu
city: Warszawa
country: Poland
facility: Samodzielny Publiczny Centralny Szpital Kliniczny, Katedra i Klinika Chorob Wewnetrznych I Endokrynologii ul. Banacha 1 a
city: Warszawa
country: Poland
facility: Szpital Bielanski im. Ks. Jerzego Popieluszki, Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Klinika Endokrynologii Centrum Medycznego Ksztalcenia Podyplomowego
city: Warszawa
country: Poland
facility: Zaklad Diagnosttyki Radiologicznej, Centralny Szpital Klincny, Ministrerstwa Spraw Wewnetrznych i Administratracji w Warzawie
city: Zabrze
country: Poland
facility: Silesian Medical University
city: Slovakia
country: Slovakia
facility: Narodny onkologicky ustav, Bratislava
city: Slovakia
country: Slovakia
facility: Vychodoslovensky onkologicky ustav, Rastislavova
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron
city: Barcelona
country: Spain
facility: Institut Catala Oncologia
city: Madrid
country: Spain
facility: Hospital G. Maranon
city: Madrid
country: Spain
facility: Hospital La Paz
city: Tenerife
country: Spain
facility: Hospital Nuestra Senora de la Candelaria
city: Goteborg
country: Sweden
facility: Sahlgrenska Hospital
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
city: Uppsala
country: Sweden
facility: University Hospital
city: Basingstoke
country: United Kingdom
facility: Basingstoke and North Hampshire Hospital
city: Belfast
country: United Kingdom
facility: Royal Victoria Hospital
city: Cardiff
country: United Kingdom
facility: University Hospital Wales
city: Edinburgh
country: United Kingdom
facility: Western General Hospital
city: Glasgow
country: United Kingdom
facility: Beatson West of Scotland Cancer Centre
city: Leeds
country: United Kingdom
facility: St James Hospital
city: Leicester
country: United Kingdom
facility: Leicester Royal Infirmary
city: London
country: United Kingdom
facility: Royal Free Hospital
city: London
country: United Kingdom
facility: St Bartholomew's Hospital
city: Nottingham
country: United Kingdom
facility: QMC
city: Oxford
country: United Kingdom
facility: Churchill Hospital
city: Sheffield
country: United Kingdom
facility: Royal Hallamshire Hospital
Study officials:
affiliation: Ipsen
name: Medical Director, Endocrinology
role: STUDY_DIRECTOR
References:
citation: Caplin ME, Pavel M, Cwikla JB, Phan AT, Raderer M, Sedlackova E, Cadiot G, Wolin EM, Capdevila J, Wall L, Rindi G, Langley A, Martinez S, Blumberg J, Ruszniewski P; CLARINET Investigators. Lanreotide in metastatic enteropancreatic neuroendocrine tumors. N Engl J Med. 2014 Jul 17;371(3):224-33. doi: 10.1056/NEJMoa1316158.
citation: Caplin ME, Pavel M, Phan AT, Cwikla JB, Sedlackova E, Thanh XT, Wolin EM, Ruszniewski P; CLARINET Investigators. Lanreotide autogel/depot in advanced enteropancreatic neuroendocrine tumours: final results of the CLARINET open-label extension study. Endocrine. 2021 Feb;71(2):502-513. doi: 10.1007/s12020-020-02475-2. Epub 2020 Oct 14.
citation: Lybaert W, Van Hul E, Woestenborghs H. Long-term disease control of a pancreatic neuroendocrine tumor with lanreotide autogel((R)): a case report. Case Rep Oncol. 2014 Sep 26;7(3):673-80. doi: 10.1159/000368207. eCollection 2014 Sep.