An Efficacy and Safety Study of Somatuline Depot (Lanreotide) Injection to Treat Carcinoid Syndrome (ELECT)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT00774930
First received: October 15, 2008
Last updated: February 26, 2014
Last verified: February 2014
  Purpose

The purpose of this study is to determine whether monthly injections of Somatuline Depot are effective and safe in controlling diarrhea and flushing in patients with carcinoid syndrome. In countries where Somatuline Depot is not approved, patients well controlled at the end of the open-label phase will be able to participate in a long-term open-label extension phase.


Condition Intervention Phase
Carcinoid Syndrome
Drug: Somatuline Depot (lanreotide)
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Double-blind, Randomized Placebo-controlled Clinical Trial Investigating the Efficacy and Safety of Somatuline Depot (Lanreotide) Injection in the Treatment of Carcinoid Syndrome

Resource links provided by NLM:


Further study details as provided by Ipsen:

Primary Outcome Measures:
  • Usage of subcutaneous octreotide to control symptoms associated with carcinoid syndrome, measured as the % of days that subcutaneous octreotide is used as rescue medication based on patient Interactive Voice Response System ( IVRS) diary records [ Time Frame: 16 week double-blind phase of the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Frequency of diarrhea events (per day) based on patient IVRS diary records. [ Time Frame: 16-week double-blind phase ] [ Designated as safety issue: No ]
  • Frequency of flushing events (per day) based on patient IVRS diary records. [ Time Frame: 16-week double-blind phase ] [ Designated as safety issue: No ]
  • Usage of other rescue medications for diarrhea and/or flushing events, measured as the percentage of days that the medications were used as rescue medication based on patient IVRS diary records. [ Time Frame: 16-week double-blind phase ] [ Designated as safety issue: No ]
  • Proportion of patients who roll over into the open-label phase before completing the double-blind phase of the study. [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
  • Changes from baseline in Quality of Life (QoL); assessed using the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire C30-Carcinoid/NETs module: EORTC QLQ-G.I. NET 21 [ Time Frame: 16-week double-blind phase ] [ Designated as safety issue: No ]
  • Absolute changes from baseline in biochemical marker - plasma Chromogranin A (CgA). [ Time Frame: 16-week double-blind phase ] [ Designated as safety issue: No ]
  • Absolute changes from baseline in biochemical marker - urinary 5-hydroxyindoleacetic acid (5-HIAA). [ Time Frame: 16-week double-blind phase ] [ Designated as safety issue: No ]

Enrollment: 115
Study Start Date: March 2009
Estimated Study Completion Date: December 2015
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Somatuline Depot 120 mg Drug: Somatuline Depot (lanreotide)
subcutaneous injection, 120 mg, q28d
Other Name: Somatuline Autogel
Placebo Comparator: Placebo Drug: placebo
inactive substance

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • histopathologically confirmed diagnosis of carcinoid tumor or a carcinoid tumor of unknown location with liver metastases
  • history of carcinoid syndrome (flushing and/or diarrhea)
  • either naive to treatment with a Somatostatin analog or responsive to conventional doses of LAR or subcutaneous octreotide
  • confirmation of positive somatostatin receptor status by somatostatin receptor scintigraphy
  • absence of tumor progression

Exclusion Criteria:

  • history of carcinoid syndrome refractory to treatment with conventional doses of Somatostatin analogs
  • treatment with interferon, chemotherapy and/or radiotherapy, a radiolabelled Somatostatin analog and/or tumor debulking < 3 months prior to study entry
  • history of hepatic arterial embolization
  • short bowel syndrome
  • uncontrolled diabetes and/or hypertension
  • severe renal impairment and/or liver impairment
  • diagnosis of cardiac disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00774930

  Hide Study Locations
Locations
United States, California
David Geffen School of Medicine at UCLA
Los Angeles, California, United States, 90095
VA Greater Los Angeles Health Care System
Los Angeles, California, United States, 90073
Stanford Cancer Center
Stanford, California, United States, 94305
Cedars Sinai Outpatient Cancer Center
West Hollywood, California, United States, 90048
United States, Kentucky
Kentuckiana Cancer Institute
Louisville, Kentucky, United States, 40202
United States, Louisiana
Louisiana State University Health Science Center
Kenner, Louisiana, United States, 70065
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
United States, New Mexico
University of New Mexico Cancer Care Center
Albuquerque, New Mexico, United States, 97239
United States, Oregon
Oregon Health Science University
Portland, Oregon, United States, 97239
Providence Portland Medical Center
Portland, Oregon, United States, 97213
United States, Pennsylvania
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
UPMC Liver Cancer Center
Pittsburgh, Pennsylvania, United States, 15213
United States, Virginia
Eastern Virginia Medical School
Norfolk, Virginia, United States, 23510
United States, Wisconsin
Froedtert & Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Brazil
Biocancer - Centro de Pesquisa e Tratamento do Câncer
Belo Horizonte, Brazil
Oxion Medicina Oncológica
Belo Horizonte, Brazil
Hospital LifeCenter
Belo Horizonte, Brazil
Hospital Universitário de Brasilia
Brasilia, Brazil
Hospital Erasto Gaertner
Curitiba, Brazil
Irmandade da Santa Casa de Misericórdia de Porto Alegre
Porto Alegre, Brazil
Hospital de Base de São José do Rio Preto
São José do Rio Preto, Brazil
Czech Republic
VFN Onkologicka klinika
Prague, Czech Republic, 12808
India
Sir Gangaram Hospital
Delhi, India
Indo-American Cancer Institute & Research Centre
Hyderabad, India
Omega Hospitals
Hyderabad, India
Santokaba Durlabhji Memorial Hospital and Research Institute
Jaipur, India, 302015
Bhagwan Mahaveer cancer hospital and research centre
Jaipur, India
Tata Memorial Hospital
Mumbai, India
Shatabdi Super Speciality hospital
Nasik, India, 422005
Latvia
Paul Stradins Clinical University Hospital
Riga, Latvia, 1002
Poland
Klinika Endokrynologii, Diabetologii i Leczenia Izotopami
Wrocław, Poland, 50-367
Russian Federation
Non-Federal Institution of Healthcare "Central Clinical Hospital # 1 of the LLC "Russian Railways (RZD)"
Moscow, Russian Federation
Russian Academy of Medical Sciences "Russian Oncological Research Centre named after N.N. Blokhin RAMS"
Moscow, Russian Federation
Federal Institution of Healthcare "Leningradsky Regional Oncological Dispensary"
Saint-Petersburg, Russian Federation
Serbia
Clinic of Endocrinology, diabetes and metabolic diseases, Clinical Center of Serbia
Belgrade, Serbia, 11000
Oncology Institute of Vojvodina, Sremska Kamenica
Sremska Kamenica, Serbia, 21 204
South Africa
Rondebosch Oncology Unit
Cape Town, South Africa, 7700
Groote Schuur Hospital
Cape Town, South Africa
Westridge Medical Centre
Durban, South Africa
GVI Oncology Clinical Trial Unit
Western Cape, South Africa, 7570
Turkey
Erciyes University Medical Faculty
Kayseri, Turkey, 38039
Ukraine
Cherkassy Regional Oncology Dispensary
Cherkassy, Ukraine
Chernivtsi Regional Oncology Center
Chernivtsi, Ukraine, 58013
Oncology and Medical Radiology Chair of Dnepropetrovsk State Medical Academy
Dnepropetrovsk, Ukraine
Regional Anticancer Center, Department of oncoproctology
Donetsk, Ukraine
Municipal Clinical Hospital #2, Proctology department
Kharkiv, Ukraine
Medical Centre "Mriya"
Kyiv, Ukraine
National Cancer Institute
Kyiv, Ukraine
Kyiv City Oncological Hospital, Thoracic department
Kyiv, Ukraine
Odessa Regional Clinical Hospital
Odessa, Ukraine, 65117
Uzhgorods'ka Tsentral'na Mis'ka Klinichna Likarnya, Mis'kyy Onkologichnyy Tsentr
Uzhgorod, Ukraine
Vinnytsya Regional Clinical Oncological Center, Vinnytsya State Medical University
Vinnytsya, Ukraine
Sponsors and Collaborators
Ipsen
Investigators
Study Director: Edda Gomez-Panzani, M.D. Ipsen
  More Information

No publications provided

Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT00774930     History of Changes
Other Study ID Numbers: 2-55-52030-730, TR321, 2010-019066-92
Study First Received: October 15, 2008
Last Updated: February 26, 2014
Health Authority: United States: Food and Drug Administration
Latvia: State Agency of Medicines
Czech Republic: State Institute for Drug Control
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
India: Drugs Controller General of India
Serbia and Montenegro: Agency for Drugs and Medicinal Devices
South Africa: Medicines Control Council
Ukraine: State Pharmacological Center - Ministry of Health
Brazil: National Health Surveillance Agency
Croatia: Ministry of Health and Social Care
Russia: Ministry of Health of the Russian Federation
Turkey: Ministry of Health

Keywords provided by Ipsen:
carcinoid tumor

Additional relevant MeSH terms:
Carcinoid Tumor
Malignant Carcinoid Syndrome
Serotonin Syndrome
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Drug Toxicity
Poisoning
Substance-Related Disorders
Lanreotide
Angiopeptin
Somatostatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Cardiovascular Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 20, 2014