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Comparison of Lanreotide Autogel® and Sandostatin LAR Depot in the Treatment of Clinical Symptoms Associated With Carcinoid Syndrome

Primary Purpose

Malignant Carcinoid Syndrome

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
lanreotide Autogel (somatostatin analogue)
Sandostatin long acting release (LAR) Depot (somatostatin analogue)
Sponsored by
Ipsen
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malignant Carcinoid Syndrome focused on measuring Carcinoid Syndrome, Neuroendocrine Tumuors

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Histologically confirmed diagnosis of a neuroendocrine tumor of the carcinoid type. Documented evidence of carcinoid syndrome (flushing and/or diarrhea) attributable to a primary tumor of the lung, stomach or mid-gut. Previous positive Octreoscan. World Health Organization (WHO) performance score lower than 2. At the baseline visit patients MUST satisfy the following criteria before they are randomized to receive study treatment: Stool and/or flushing frequency of greater than or equal to 3 episodes/day (average over a minimum five consecutive days). Patients who have previously been treated with somatostatin analogues must have discontinued treatment for a sufficient period of time (a washout period of at least 7 days for immediate release formulations and up to 2 months for prolonged release formulations is usually required). Compared with their "controlled" state on treatment, these patients must show a clinically significant deterioration (at least two episodes) of either symptom. For example, a patient considered to be controlled on their previous treatment with an estimated stool frequency of two episodes per day, must achieve a stool frequency of at least four episodes per day (average over a minimum five consecutive days). WHO performance score lower than 2. Exclusion Criteria: VIPoma or other non-carcinoid tumor. Treatment with interferon, chemotherapy or radiotherapy given within 30 days prior to inclusion, or planned during the study. Radionuclide treatment within three months prior to inclusion, or planned during the study. Presence of other active malignant pathology (except basal cellular carcinoma of the skin and/or in situ carcinoma of the cervix/uterus). Surgical procedure or embolization procedure (with or without cytotoxic agents) of the tumor within three months prior to inclusion, or planned during the study. Life expectancy of less than 6 months. Any investigational drug given within 30 days prior to inclusion or expected to be given during the study. No access to a telephone for completion of the daily telephone diary.

Sites / Locations

  • Larry Kvols, MD

Outcomes

Primary Outcome Measures

Target symptom frequency (flushing or stool frequency).

Secondary Outcome Measures

Full Information

First Posted
September 22, 2004
Last Updated
April 28, 2020
Sponsor
Ipsen
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1. Study Identification

Unique Protocol Identification Number
NCT00092287
Brief Title
Comparison of Lanreotide Autogel® and Sandostatin LAR Depot in the Treatment of Clinical Symptoms Associated With Carcinoid Syndrome
Official Title
A Phase III, Prospective, Multicenter, Randomized, Open, Parallel Group Comparison of Lanreotide Autogel® (90 and 120 mg) Administered by Deep Subcutaneous Injection Every Four Weeks, With Sandostatin LAR Depot (20 and 30 mg) Administered by Intramuscular Injection, Every Four Weeks for Six Months, in the Treatment of Clinical Symptoms Associated With Carcinoid Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Terminated
Study Start Date
July 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ipsen

4. Oversight

5. Study Description

Brief Summary
The aim of this study is to compare the efficacy and safety of lanreotide Autogel and Sandostatin LAR Depot, to see whether these two 28-day prolonged release formulations produce a similar clinical response in patients with carcinoid syndrome.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Carcinoid Syndrome
Keywords
Carcinoid Syndrome, Neuroendocrine Tumuors

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
lanreotide Autogel (somatostatin analogue)
Intervention Type
Drug
Intervention Name(s)
Sandostatin long acting release (LAR) Depot (somatostatin analogue)
Primary Outcome Measure Information:
Title
Target symptom frequency (flushing or stool frequency).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically confirmed diagnosis of a neuroendocrine tumor of the carcinoid type. Documented evidence of carcinoid syndrome (flushing and/or diarrhea) attributable to a primary tumor of the lung, stomach or mid-gut. Previous positive Octreoscan. World Health Organization (WHO) performance score lower than 2. At the baseline visit patients MUST satisfy the following criteria before they are randomized to receive study treatment: Stool and/or flushing frequency of greater than or equal to 3 episodes/day (average over a minimum five consecutive days). Patients who have previously been treated with somatostatin analogues must have discontinued treatment for a sufficient period of time (a washout period of at least 7 days for immediate release formulations and up to 2 months for prolonged release formulations is usually required). Compared with their "controlled" state on treatment, these patients must show a clinically significant deterioration (at least two episodes) of either symptom. For example, a patient considered to be controlled on their previous treatment with an estimated stool frequency of two episodes per day, must achieve a stool frequency of at least four episodes per day (average over a minimum five consecutive days). WHO performance score lower than 2. Exclusion Criteria: VIPoma or other non-carcinoid tumor. Treatment with interferon, chemotherapy or radiotherapy given within 30 days prior to inclusion, or planned during the study. Radionuclide treatment within three months prior to inclusion, or planned during the study. Presence of other active malignant pathology (except basal cellular carcinoma of the skin and/or in situ carcinoma of the cervix/uterus). Surgical procedure or embolization procedure (with or without cytotoxic agents) of the tumor within three months prior to inclusion, or planned during the study. Life expectancy of less than 6 months. Any investigational drug given within 30 days prior to inclusion or expected to be given during the study. No access to a telephone for completion of the daily telephone diary.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ipsen Medical Director
Organizational Affiliation
Ipsen
Official's Role
Study Director
Facility Information:
Facility Name
Larry Kvols, MD
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Comparison of Lanreotide Autogel® and Sandostatin LAR Depot in the Treatment of Clinical Symptoms Associated With Carcinoid Syndrome

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