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

  Show 54 Study Locations
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:
Syndrome
Carcinoid Tumor
Malignant Carcinoid Syndrome
Serotonin Syndrome
Disease
Pathologic Processes
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Angiopeptin
Lanreotide
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 October 01, 2014