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

This study has been terminated.
Sponsor:
Information provided by:
Ipsen
ClinicalTrials.gov Identifier:
NCT00092287
First received: September 22, 2004
Last updated: February 25, 2008
Last verified: February 2008

September 22, 2004
February 25, 2008
July 2004
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Target symptom frequency (flushing or stool frequency).
Same as current
Complete list of historical versions of study NCT00092287 on ClinicalTrials.gov Archive Site
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Comparison of Lanreotide Autogel® and Sandostatin LAR Depot in the Treatment of Clinical Symptoms Associated With Carcinoid Syndrome
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

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.

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Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Malignant Carcinoid Syndrome
  • Drug: lanreotide Autogel (somatostatin analogue)
  • Drug: Sandostatin long acting release (LAR) Depot (somatostatin analogue)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
196
October 2004
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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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00092287
2-47-52030-722
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Ipsen
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Study Director: France Catus, MD Ipsen
Ipsen
February 2008

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