An Efficacy and Safety Study of Somatuline Depot (Lanreotide) Injection to Treat Carcinoid Syndrome

This study is currently recruiting participants.

Verified by Tercica, March 2009

First Received: October 15, 2008 Last Updated: March 20, 2009 History of Changes

Sponsors and Collaborators:	Tercica Ipsen
Information provided by:	Tercica
ClinicalTrials.gov Identifier:	NCT00774930

Purpose

The purpose of this study is to determine whether monthly injections of Somatuline Depot are effective and safe in controlling diarrhea and flushing in patients with carcinoid syndrome.

Condition	Intervention	Phase
Carcinoid Syndrome	Drug: lanreotide Drug: placebo	Phase III

MedlinePlus related topics: Cancer Carcinoid Tumors

Drug Information available for: Lanreotide acetate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	A Double-Blind, Randomized Placebo-Controlled Clinical Trial Investigating the Efficacy and Safety of Somatuline Depot (Lanreotide) Injection in the Treatment of Carcinoid Syndrome

Further study details as provided by Tercica:

Primary Outcome Measures:

Usage of subcutaneous octreotide required to control symptoms associated with carcinoid syndrome, during the 16-week double-blind phase of the study based on patient IVRS diary records [ Time Frame: Week 16 ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	March 2009
Estimated Study Completion Date:	September 2011
Estimated Primary Completion Date:	September 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Somatuline Depot 120 mg	Drug: lanreotide subcutaneous injection, 120 mg, q28d
2: Placebo Comparator Placebo	Drug: placebo inactive substance

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

histopathologically confirmed diagnosis of carcinoid tumor
history of carcinoid syndrome (flushing and/or diarrhea)
either naive to treatment with a Somatostatin analog or responsive to conventional doses of LAR or subcutaneous octreotide
confirmation of positive somatostatin receptor status by somatostatin receptor scintigraphy
absence of tumor progression

Exclusion Criteria:

history of carcinoid syndrome refractory to treatment with conventional doses of Somatostatin analogs
treatment with interferon, chemotherapy and/or radiotherapy, a radiolabelled Somatostatin analog and/or tumor debulking < 3 months prior to study entry
history of hepatic arterial embolization
short bowel syndrome
uncontrolled diabetes and/or hypertension
severe renal impairment and/or liver impairment
diagnosis of cardiac disease

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00774930

Contacts

Contact: Rodney van Syoc	650-238-1598	rodney.vanSyoc@tercica.com
Contact: Katrin Chondros	650-238-1565	katrin.chondros@tercica.com

Locations

United States, Oregon
Providence Portland Medical Center	Recruiting
Portland, Oregon, United States, 97213
Contact: Katie Strauss 503-215-2619
Principal Investigator: Todd Crocenzi, MD
United States, Virginia
Eastern Virginia Medical School	Recruiting
Norfolk, Virginia, United States, 23510
Contact: Patricia Barlow 757-446-5293
Principal Investigator: Aaron Vinik, MD

Sponsors and Collaborators

Tercica

Ipsen

Investigators

Study Chair:

Edda Gomez-Panzani, M.D.

Tercica

More Information

No publications provided

Responsible Party:	Tercica ( Edda Gomez-Panzani, MD )
Study ID Numbers:	TR321
Study First Received:	October 15, 2008
Last Updated:	March 20, 2009
ClinicalTrials.gov Identifier:	NCT00774930 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Tercica:

carcinoid tumor

Study placed in the following topic categories:

Carcinoid Syndrome
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Serotonin Syndrome
Poisoning
Angiopeptin
Disorders of Environmental Origin
Cardiovascular Agents
Malignant Carcinoid Syndrome
Hormones
Somatostatin

Neuroendocrine Tumors
Carcinoma
Neuroectodermal Tumors
Lanreotide
Drug Toxicity
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Carcinoid Tumor
Adenocarcinoma
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Antineoplastic Agents
Physiological Effects of Drugs
Neoplasms, Nerve Tissue
Hormones, Hormone Substitutes, and Hormone Antagonists
Disorders of Environmental Origin
Angiopeptin
Hormones
Pathologic Processes
Neoplasms, Germ Cell and Embryonal
Syndrome
Therapeutic Uses
Neoplasms by Histologic Type
Disease
Serotonin Syndrome

Poisoning
Malignant Carcinoid Syndrome
Cardiovascular Agents
Somatostatin
Pharmacologic Actions
Carcinoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms
Lanreotide
Drug Toxicity
Carcinoid Tumor
Adenocarcinoma
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 07, 2009