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

Sponsor:	Ipsen
Information provided by:	Ipsen
ClinicalTrials.gov Identifier:	NCT00092287

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 III

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:

MedlinePlus related topics: Carcinoid Tumors

Drug Information available for: Somatostatin Octreotide acetate Octreotide Lanreotide acetate

U.S. FDA Resources

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

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
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Drug Toxicity
Poisoning

Substance-Related Disorders
Octreotide
Lanreotide
Angiopeptin
Somatostatin
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Gastrointestinal Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cardiovascular Agents

ClinicalTrials.gov processed this record on February 12, 2012