An Efficacy and Safety Study of Somatuline Depot (Lanreotide) Injection to Treat Carcinoid Syndrome (ELECT)
Carcinoid Syndrome
About this trial
This is an interventional treatment trial for Carcinoid Syndrome focused on measuring Carcinoid tumor, Somatuline Depot, Lanreotide Autogel, Neuroendocrine tumor, NET, Diarrhea, Flushing, Carcinoid tumour, Neuroendocrine tumour, Diarrhoea
Eligibility Criteria
Subjects were eligible for participation in the study if they met the following criteria:
- At least 18 years of age at the time of first dosing.
- Subjects must have given signed informed consent before any study related activities were conducted.
- Subjects in the United States of America (USA) must have given written authorisation for the release of protected health information in compliance with the Health Insurance Portability and Accountability Act (HIPAA) regulations; subjects in other countries must have provided appropriate authorisation as needed by regulatory authorities in each country.
- Subjects must have been willing to receive s.c. octreotide injections as rescue medication, as needed to control their symptoms, if any.
If female, the subject must not have been pregnant (confirmed by negative pregnancy test) and must have had the following documented via verbally given history:
- At least 1 year postmenopausal (natural cessation of menses), or
- Surgically sterile (if by tubal ligation, surgery must have been performed more than 3 months prior to entry into the study), or
- If the subject was of childbearing potential and sexually active, she must have been using an acceptable form of contraception (oral, injected, transdermal or implanted contraceptives, diaphragm or barrier method with spermicidal and/or intrauterine device); local methods such as condoms or sponges/vaginal tablets were not acceptable forms of contraception.
- Subjects with a histopathologically confirmed diagnosis of carcinoid tumour or, a carcinoid tumour of unknown location with liver metastases (documented biopsy), and a history of carcinoid syndrome (flushing and/or diarrhoea) who were either naïve to treatment with a somatostatin analogue (SSTa) or responsive (according to the opinion of the principal investigator) to conventional doses of Sandostatin LAR® Depot (LAR; ≤30 mg every 4 weeks) or to daily doses of ≤600 μg of s.c. octreotide.
- Confirmation of positive somatostatin receptor (SSTR) status by somatostatin receptor scintigraphy (SRS; up to 6 months prior to study entry at the Screening Visit).
- Absence of tumour progression documented by two sequential computed tomography (CT) scans or two sequential magnetic resonance imaging (MRI) scans (≥3 months apart); the last CT or MRI scan must have been performed within 6 months of study entry (Screening Visit).
- Subjects previously treated with LAR, must have received their last dose of LAR at least 4 weeks prior to first dose of study treatment (no later than at the Screening Visit).
- Be able to communicate and cooperate with the principal investigator and the staff and willing to comply with the study instructions.
Subjects were excluded from entering the study for the following reasons:
- History of known allergy or hypersensitivity to investigational drug or any components of its formulation, or octreotide.
- History of carcinoid syndrome refractory to treatment with conventional doses of SSTa.
- Treatment with any other investigational drug within 30 days prior to study entry (Screening Visit) and/or at any time during the subject's participation in the study.
- Treatment with interferon, chemotherapy and/or radiotherapy (a radiolabelled SSTa) and/or tumour debulking <3 months prior to study entry (Screening Visit).
- History of hepatic arterial embolisation, hepatic arterial chemoembolisation and/or selective internal radiation therapy (selective internal radiation [SIR] therapy [SIRT]; e.g. SIR Spheres) <6 months prior to study entry (Screening Visit).
- Short bowel syndrome.
- Uncontrolled diabetes and/or hypertension.
- Severe renal impairment (glomerular filtration rate <30 mL/min/1.73 m2) and/or severe liver impairment as evidenced by serum total bilirubin >1.5 mg/dL associated with bile duct blockage or with alkaline phosphatase (ALP), aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >5.0 upper limit of normal (ULN).
- Diagnosis of cardiac disease New York Heart Association (NYHA) functional classification >Class I. (Subject has limitation of physical activity. Ordinary physical activity causes undue fatigue, palpitation, or dyspnoea).
- Life expectancy less than 1 year.
- Any malignancies except carcinoid tumour, basocellular carcinoma of the skin, in situ carcinoma of the cervix and ≥5 years disease free after curative cancer treatment.
- Any serious medical condition that could jeopardise the safety of the subject and/or the efficacy assessments of the study.
- Subject is being treated with a proton pump inhibitor (PPI) and has been at a stable dose (no change in dose or frequency of administration) for less than 4 weeks at study entry (Screening Visit).
Sites / Locations
- VA Greater Los Angeles Health Care System
- David Geffen School of Medicine at UCLA
- Stanford Cancer Center
- Cedars Sinai Outpatient Cancer Center
- Kentuckiana Cancer Institute
- Louisiana State University Health Science Center
- University of Michigan
- University of Mississippi Medical Center
- University of New Mexico Cancer Care Center
- Providence Portland Medical Center
- Oregon Health Science University
- Penn State Milton S. Hershey Medical Center
- University of Pennsylvania
- UPMC Liver Cancer Center
- Eastern Virginia Medical School
- Froedtert & Medical College of Wisconsin
- Biocancer - Centro de Pesquisa e Tratamento do Câncer
- Hospital LifeCenter
- Oxion Medicina Oncológica
- Hospital Universitário de Brasilia
- Hospital Erasto Gaertner
- Irmandade da Santa Casa de Misericórdia de Porto Alegre
- Hospital de Base de São José do Rio Preto
- VFN Onkologicka klinika
- Sir Gangaram Hospital
- Indo-American Cancer Institute & Research Centre
- Omega Hospitals
- Santokaba Durlabhji Memorial Hospital and Research Institute
- Bhagwan Mahaveer cancer hospital and research centre
- Shatabdi Super Speciality hospital
- Tata Memorial Hospital
- Paul Stradins Clinical University Hospital
- Klinika Endokrynologii, Diabetologii i Leczenia Izotopami
- Non-Federal Institution of Healthcare "Central Clinical Hospital # 1 of the LLC "Russian Railways (RZD)"
- Russian Academy of Medical Sciences "Russian Oncological Research Centre named after N.N. Blokhin RAMS"
- Federal Institution of Healthcare "Leningradsky Regional Oncological Dispensary"
- Clinic of Endocrinology, diabetes and metabolic diseases, Clinical Center of Serbia
- Oncology Institute of Vojvodina, Sremska Kamenica
- Rondebosch Oncology Unit
- Groote Schuur Hospital
- Westridge Medical Centre
- GVI Oncology Clinical Trial Unit
- Erciyes University Medical Faculty
- Cherkassy Regional Oncology Dispensary
- Chernivtsi Regional Oncology Center
- Oncology and Medical Radiology Chair of Dnepropetrovsk State Medical Academy
- Regional Anticancer Center, Department of oncoproctology
- Municipal Clinical Hospital #2, Proctology department
- Kyiv City Oncological Hospital, Thoracic department
- Medical Centre "Mriya"
- National Cancer Institute
- Odessa Regional Clinical Hospital
- Uzhgorods'ka Tsentral'na Mis'ka Klinichna Likarnya, Mis'kyy Onkologichnyy Tsentr
- Vinnytsya Regional Clinical Oncological Center, Vinnytsya State Medical University
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Lanreotide Autogel (Somatuline Depot) 120 mg
Placebo (DB) and lanreotide Autogel 120 mg in IOL and LTOLE
Subjects received deep s.c. lanreotide Autogel 120 mg every 4 weeks (±3 days) for 16 weeks (DB phase). After completing the DB phase (or if they met criteria for early roll over [ERO]) the subjects entered the IOL phase during which they received lanreotide Autogel 120 mg deep s.c. every 4 weeks for 32 weeks. During the LTOLE phase, subjects continued treatment with lanreotide Autogel 120 mg deep s.c. every 4 weeks until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]).
Subjects received deep s.c. placebo every 4 weeks (±3 days) for 16 weeks (DB phase). After completing the DB phase (or if they met criteria for ERO) the subjects entered the IOL phase during which they received lanreotide Autogel 120 mg deep s.c. every 4 weeks for 32 weeks. During the LTOLE phase, subjects continued treatment with lanreotide Autogel 120 mg deep s.c. every 4 weeks until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]).