We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00092287
Recruitment Status : Terminated
First Posted : September 27, 2004
Last Update Posted : February 27, 2008
Sponsor:
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Malignant Carcinoid Syndrome Drug: lanreotide Autogel (somatostatin analogue) Drug: Sandostatin long acting release (LAR) Depot (somatostatin analogue) Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 196 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : July 2004
Study Completion Date : October 2004


Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Target symptom frequency (flushing or stool frequency).

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00092287


Locations
United States, Florida
Larry Kvols, MD
Tampa, Florida, United States, 33612
Sponsors and Collaborators
Ipsen
Investigators
Study Director: France Catus, MD Ipsen
More Information

ClinicalTrials.gov Identifier: NCT00092287     History of Changes
Other Study ID Numbers: 2-47-52030-722
First Posted: September 27, 2004    Key Record Dates
Last Update Posted: February 27, 2008
Last Verified: February 2008

Keywords provided by Ipsen:
Carcinoid Syndrome
Neuroendocrine Tumuors

Additional relevant MeSH terms:
Malignant Carcinoid Syndrome
Serotonin Syndrome
Syndrome
Carcinoid Tumor
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
Somatostatin
Lanreotide
Angiopeptin
Octreotide
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents
Gastrointestinal Agents
Antineoplastic Agents, Hormonal