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

NCT00092287 | Terminated Phase 3

• 2 other identifiers: 2-47-52030-7222004-001091-40
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Malignant Carcinoid Syndrome

Keywords

Carcinoid Syndrome; Neuroendocrine Tumuors

Outcome Measures

Primary Outcomes (1)

• Target symptom frequency (flushing or stool frequency).

Interventions

lanreotide Autogel (somatostatin analogue) DRUG

Sandostatin long acting release (LAR) Depot (somatostatin analogue) DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• VIPoma or other non-carcinoid tumor.
• Presence of other active malignant pathology (except basal cellular carcinoma of the skin and/or in situ carcinoma of the cervix/uterus).
• Life expectancy of less than 6 months.
• No access to a telephone for completion of the daily telephone diary.

Sponsors & Collaborators

• Ipsen: lead

Study Sites (1)

Larry Kvols, MD

Tampa, Florida, 33612, United States

Location

MeSH Terms

Conditions

Malignant Carcinoid Syndrome; Serotonin Syndrome

Interventions

Receptor-Like Protein Tyrosine Phosphatases, Class 2

Condition Hierarchy (Ancestors)

Carcinoid Tumor; 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

Intervention Hierarchy (Ancestors)

Receptor-Like Protein Tyrosine Phosphatases; Protein Tyrosine Phosphatases; Phosphoric Monoester Hydrolases; Esterases; Hydrolases; Enzymes; Enzymes and Coenzymes; Intracellular Signaling Peptides and Proteins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Ipsen Medical Director

  Ipsen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2004
• First Posted: September 27, 2004
• Study Start: July 1, 2004
• Study Completion: October 1, 2004
• Last Updated: April 30, 2020

Record last verified: 2020-04

Locations

US (1)