Study of Lanreotide Autogel in Non-functioning Entero-pancreatic Endocrine Tumours
- Conditions
- Endocrine Tumors
- Interventions
- Drug: Placebo
- Registration Number
- NCT00353496
- Lead Sponsor
- Ipsen
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 264
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description lanreotide (Autogel formulation) lanreotide (Autogel formulation) - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Progression-Free Survival (PFS) 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 Time from randomization to first documentation of disease progression, or death. Disease progression centrally assessed using Response Evaluation Criteria in Solid Tumours (RECIST) v1.0
- Secondary Outcome Measures
Name Time Method Change in the Global Health Status Quality of Life Assessment Week 12 to Week 96 (last visit) Transformed scores from European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire responses (QLQ)-C30. Questionnaire response scores range from 0 to 100. Higher scores indicate best possible Quality of Life.
Percentage of Patients With a Greater Than or Equal to 50% Decrease in Plasma Chromogranin A (CgA) Levels Week 12 to Week 96 (last visit) Pharmacokinetic Profile of Lanreotide Week 4, 12, 24, 36, 48, 72, 96 Pharmacokinetic Profile of Lanreotide assessed by mean serum concentration at specified timepoints
Percentage of Patients Still Alive Based on Available Overall Survival Data Randomisation to death or last visit, up to 321 weeks Overall survival defined as the time from randomisation to death due to any cause. Subjects were followed for overall survival beyond study completion/withdrawal via annual telephone contact until the last subject completed the study.
Percentage of Patients Alive & Without Disease Progression Week 48 & 96 Percentage of patients still ongoing (or completing at Week 96) without centrally assessed disease progression or death at Weeks 48 and 96.
Related Research Topics
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Trial Locations
- Locations (67)
Cedars-Sinai Outpatient Cancer Center
🇺🇸Los Angeles, California, United States
University of Iowa
🇺🇸Iowa City, Iowa, United States
The John Hopkins Hospital
🇺🇸Baltimore, Maryland, United States
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States
University of Wisconsin School of Medicine and Public Health
🇺🇸Madison, Wisconsin, United States
Providence Portland Medical Center
🇺🇸Portland, Oregon, United States
MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
University Hospital
🇸🇪Uppsala, Sweden
UZ Antwerpen
🇧🇪Antwerpen, Belgium
UCL Saint Luc
🇧🇪Bruxelles, Belgium
Fekultni nemocnice Olomouc
🇨🇿Olomouc, Czechia
General faculty
🇨🇿Praha, Czechia
Rigshospitalet
🇩🇰Copenhagen, Denmark
Hôpital Beaujon
🇫🇷Clichy, France
Hôpital A. Paré
🇫🇷Boulogne Billancourt, France
CAC Oscar Lambret
🇫🇷Lille, France
Hôpital Edouard Herriot
🇫🇷Lyon, France
CHU la Timone
🇫🇷Marseille, France
CHI Frejus St Raphael
🇫🇷St Raphael, France
Hôpital R. Debré
🇫🇷Reims, France
Hôpital Rangueil
🇫🇷Toulouse, France
Unité de gastro enterologie IGR
🇫🇷Villejuif, France
Gutenberg University Hospital
🇩🇪Mainz, Germany
Charite Hospital
🇩🇪Berlin, Germany
Lukas Hospital
🇩🇪Neuss, Germany
Tata Memorial Hospital
🇮🇳Mumbai, India
Global Hospital
🇮🇳Hyderabad, India
Centro di Refierimiento Oncologica
🇮🇹Aviano, Italy
INSCT
🇮🇹Milano, Italy
Azienda Malpighi
🇮🇹Bologna, Italy
University of Naples
🇮🇹Naples, Italy
Azienda San Giovanni Battista
🇮🇹Torino, Italy
Hospital S. Chiara
🇮🇹Pisa, Italy
Erasmu MC
🇳🇱Rotterdam, Netherlands
UMC Utrecht
🇳🇱Utrecht, Netherlands
Centrum Onkologii-Instytut im. Marii Sklodowskiej - Curie, oddzial w Gliwicach, Zaklad Medycyny Nuklearnej i Endokrynologii Onkologicznej ul.
🇵🇱Gliwice, Poland
Katedra i Klinika Endokrynologii Przemiany Materii i Chorob Wewnetrznych Uniwersytetu Medycznego w Poznaniu
🇵🇱Poznan, Poland
Samodzielny Publiczny Centralny Szpital Kliniczny, Katedra i Klinika Chorob Wewnetrznych I Endokrynologii ul. Banacha 1 a
🇵🇱Warszawa, Poland
Szpital Bielanski im. Ks. Jerzego Popieluszki, Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Klinika Endokrynologii Centrum Medycznego Ksztalcenia Podyplomowego
🇵🇱Warszawa, Poland
Silesian Medical University
🇵🇱Zabrze, Poland
Narodny onkologicky ustav, Bratislava
🇸🇰Slovakia, Slovakia
Hospital Vall d'Hebron
🇪🇸Barcelona, Spain
Vychodoslovensky onkologicky ustav, Rastislavova
🇸🇰Slovakia, Slovakia
Institut Catala Oncologia
🇪🇸Barcelona, Spain
Hospital G. Maranon
🇪🇸Madrid, Spain
Hospital La Paz
🇪🇸Madrid, Spain
Hospital Nuestra Senora de la Candelaria
🇪🇸Tenerife, Spain
Sahlgrenska Hospital
🇸🇪Goteborg, Sweden
Karolinska University Hospital
🇸🇪Stockholm, Sweden
Basingstoke and North Hampshire Hospital
🇬🇧Basingstoke, United Kingdom
Royal Victoria Hospital
🇬🇧Belfast, United Kingdom
University Hospital Wales
🇬🇧Cardiff, United Kingdom
St James Hospital
🇬🇧Leeds, United Kingdom
Leicester Royal Infirmary
🇬🇧Leicester, United Kingdom
Western General Hospital
🇬🇧Edinburgh, United Kingdom
Beatson West of Scotland Cancer Centre
🇬🇧Glasgow, United Kingdom
Royal Free Hospital
🇬🇧London, United Kingdom
St Bartholomew's Hospital
🇬🇧London, United Kingdom
QMC
🇬🇧Nottingham, United Kingdom
Royal Hallamshire Hospital
🇬🇧Sheffield, United Kingdom
Churchill Hospital
🇬🇧Oxford, United Kingdom
Fakultni nemocnice Na
🇨🇿Bulovce, Prague, Czechia
Sygehus Hospital
🇩🇰Aarhus, Denmark
Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
UZ Gent
🇧🇪Gent, Belgium
Zaklad Diagnosttyki Radiologicznej, Centralny Szpital Klincny, Ministrerstwa Spraw Wewnetrznych i Administratracji w Warzawie
🇵🇱Warszawa, Poland
UMC Gronigen
🇳🇱Gronigen, Netherlands