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

October 15, 2008
January 7, 2016
May 2009
May 2013   (final data collection date for primary outcome measure)
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
Usage of subcutaneous octreotide required to control symptoms associated with carcinoid syndrome, during the 16-week double-blind phase of the study based on patient IVRS diary records [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00774930 on ClinicalTrials.gov Archive Site
  • 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
Not Provided
Not Provided
Not Provided
 
An Efficacy and Safety Study of Somatuline Depot (Lanreotide) Injection to Treat Carcinoid Syndrome
A Double-blind, Randomized Placebo-controlled Clinical Trial Investigating the Efficacy and Safety of Somatuline Depot (Lanreotide) Injection in the Treatment of Carcinoid Syndrome
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Carcinoid Syndrome
  • Drug: Somatuline Depot (lanreotide)
    subcutaneous injection, 120 mg, q28d
    Other Name: Somatuline Autogel
  • Drug: placebo
    inactive substance
  • Experimental: Somatuline Depot 120 mg
    Intervention: Drug: Somatuline Depot (lanreotide)
  • Placebo Comparator: Placebo
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
115
December 2015
May 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Brazil,   Czech Republic,   India,   Latvia,   Poland,   Russian Federation,   Serbia,   South Africa,   Turkey,   Ukraine
Croatia
 
NCT00774930
2-55-52030-730, TR321, 2010-019066-92
Yes
Not Provided
Not Provided
Ipsen
Ipsen
Not Provided
Study Director: Edda Gomez-Panzani, M.D. Ipsen
Ipsen
December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP