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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
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Ipsen:

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

Estimated Enrollment: 196
Study Start Date: July 2004
Study Completion Date: October 2004
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00092287     History of Changes
Other Study ID Numbers: 2-47-52030-722
Study First Received: September 22, 2004
Last Updated: February 25, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Ipsen:
Carcinoid Syndrome
Neuroendocrine Tumuors

Additional relevant MeSH terms:
Carcinoid Tumor
Malignant Carcinoid Syndrome
Serotonin Syndrome
Syndrome
Adenocarcinoma
Carcinoma
Chemically-Induced Disorders
Disease
Drug-Related Side Effects and Adverse Reactions
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
Pathologic Processes
Angiopeptin
Lanreotide
Octreotide
Somatostatin
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Cardiovascular Agents
Gastrointestinal Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014