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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT00774930
First received: October 15, 2008
Last updated: January 7, 2016
Last verified: December 2015
  Purpose
The purpose of this study is to determine whether monthly injections of Somatuline Depot are effective and safe in controlling diarrhea and flushing by reducing the usage of short acting octreotide as rescue medication 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:
  • Percentage of Days That Subcutaneous Octreotide is Used as Rescue Medication [ Time Frame: 16 week double-blind phase of the study ] [ Designated as safety issue: No ]
    Usage of subcutaneous octreotide to control symptoms associated with carcinoid syndrome, measured as the percentage of days that subcutaneous octreotide is used as rescue medication based on patient Interactive Voice Response System (IVRS) diary records


Secondary Outcome Measures:
  • Average Frequency of Diarrhea Events (Per Day) Based on Patient IVRS Diary Records. [ Time Frame: 16-week double-blind phase ] [ Designated as safety issue: No ]
  • Average Frequency of Flushing Events (Per Day) Based on Patient IVRS Diary Records. [ Time Frame: 16-week double-blind phase ] [ Designated as safety issue: No ]
  • Percentage of Days of Use of Other Rescue Medication [ 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.

  • Percentage of Subjects 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 Global Health Status/Quality of Life (QoL) Scores [Based on Items 29 and 30 of the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ) C30] [ Time Frame: Baseline and Week 12 double-blind phase ] [ Designated as safety issue: No ]

    Baseline is defined as the last non-missing observation obtained prior to the initiation of study treatment.

    Q29 & Q30 range from 1(=Very poor) to 7(=Excellent) with 1 being worst case & 7 most favourable answer. Scores will be derived according to EORTC scoring manual. All of the scores range in score 0-100.A high score for global health status/QoL represents high QoL. The principle for scoring the scale is: Estimate the average of the items (I1, I2, ..., In) that contribute to the scale; this is the raw score. Raw score = RS = (I1 + I2 +…+ In)/n.

    For global health status/QOL: Score = {(RS - 1)/range} x 100, where range is the difference between the maximum possible value of RS and the minimum possible value of RS.


  • Changes From Baseline in "G.I. Symptoms" Score [Assessed Based on Items Q34, Q35, Q36, Q37, Q38 of EORTC Gastrointestinal (GI) NET 21] [ Time Frame: Baseline and Week 12 double blind phase ] [ Designated as safety issue: No ]

    Baseline is defined as the last non-missing observation obtained prior to the initiation of study treatment.

    The QLQ-G.I.NET21 questionnaire contains 21 single items (Q31 to Q51) which are supplemental items to the EORTC QLQ-C30 questionnaire. Q31 to Q51 range from 1 to 4 with 1 being the most favourable answer and 4 the worst case (1 = Not at all, 2 = A little, 3 = Quite a bit, 4 = Very much). Based on these items the scores will be generated. All of the scores range in score 0-100.A high score for a symptom scale represents a high level of symptomatology. The principle for scoring the scale is: Estimate the average of the items (I1, I2, ..., In) that contribute to the scale; this is the raw score. Raw score = RS = (I1 + I2 +…+ In)/n.

    For symptom scales: Score = {(RS - 1)/range} x 100, where range is the difference between the maximum possible value of RS and the minimum possible value of RS.


  • Changes From Baseline in QoL in "Endocrine Symptoms" Score [Assessed Based on Items Q31, Q32, Q33 Using EORTC QLQ- G.I. Neuroendocrine Tumour (NET) 21 Questionnaires] [ Time Frame: Baseline and Week 12 double blind phase ] [ Designated as safety issue: No ]

    Baseline is defined as the last non-missing observation obtained prior to the initiation of study treatment.

    The QLQ-G.I.NET21 questionnaire contains 21 single items (Q31 to Q51) which are supplemental items to the EORTC QLQ-C30 questionnaire. Q31 to Q51 range from 1 to 4 with 1 being the most favourable answer and 4 the worst case (1 = Not at all, 2 = A little, 3 = Quite a bit, 4 = Very much). Based on these items the scores will be generated. All of the scores range in score 0-100.A high score for a symptom scale represents a high level of symptomatology. The principle for scoring the scale is: Estimate the average of the items (I1, I2, ..., In) that contribute to the scale; this is the raw score. Raw score = RS = (I1 + I2 +…+ In)/n.

    For symptom scales: Score = {(RS - 1)/range} x 100, where range is the difference between the maximum possible value of RS and the minimum possible value of RS.


  • Absolute Changes From Baseline in Biochemical Markers - Plasma Chromogranin A (CgA) [ Time Frame: Baseline and Week 12 double blind phase ] [ Designated as safety issue: No ]
    Baseline is defined as the last non missing observation obtained prior to the initiation of study treatment

  • Absolute Changes From Baseline in Biochemical Markers - Urinary 5-hydroxyindoleacetic Acid (5-HIAA) [ Time Frame: Baseline and Week 12 double blind phase ] [ Designated as safety issue: No ]
    Baseline is defined as the last non missing observation obtained prior to the initiation of study treatment


Enrollment: 115
Study Start Date: May 2009
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   (Adult, Senior)
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 (long-acting release) 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

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
Results First Received: August 5, 2015
Last Updated: January 7, 2016
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
Lanreotide
Angiopeptin
Somatostatin
Antineoplastic Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on December 02, 2016