High Dose Somatostatin Analogues in Neuroendocrine Tumors (HIDONET)

• ClinicalTrials.gov Identifier: NCT00990535
• Recruitment Status: Completed
• First Posted: October 7, 2009
• Last Update Posted: October 7, 2009
• Sponsor: Federico II University
• Collaborators: University of Perugia, Faculty of Medicine, Department of Internal Medicine; University of Genova; University Hospital, Udine, Italy
• Information provided by: Federico II University

Study Description

Brief Summary:

Octreotide (OCT) is a somatostatin analogue (SSA) available in a long-acting formulation, conventionally administered every 28 days at the maximum dose of 30 mg. Together with lanreotide, it is considered the therapy of choice in the control of endocrine syndromes associated with neuroendocrine tumors (NET)s. A complete or partial clinical response to SSA therapy is generally achieved in at least 50% of the patients with neuroendocrine syndrome. Many studies reported a clinical response in 70-90% of functioning NETs. In about 36-50% of the patients with progressive advanced well differentiated NET (WDNET), a stabilization of disease occurs after treatment with subcutaneous OCT. By developing long-acting slow-release SSA formulation, long-acting OCT (LAR), lanreotide-SR, lanreotide-Autogel, the patient's compliance to SSA therapy was improved and escape from treatment, which was common with the subcutaneous formulation, was avoided. However, rate of objective response was not significantly improved as compared to short-acting SSA. On the other hand, it has to be remarked that long-acting SSA are being used in NET patients at doses correspondent to the low doses of short-acting formulation. The higher commercially available doses of LAR is 30 mg, which is assumed to be comparable to 300 µg of short-acting OCT in the therapy of acromegaly.

Only one study was designed to investigate the use of high-dose LAR (160 mg every 28 days). In this study, objective and hormonal responses in patients with progressive metastatic ileal NET non-responder to standard doses, was significantly elevated. However, this compound has never been commercialized and, of consequence, this first preliminary observation has not been confirmed by further studies.

No systematic studies were performed with the commercially available long-acting SSA used in high-dose treatments. In patients with progressive locally advanced or metastatic NET, increase of the dose or reduction of the interval between injections is a relatively common "empirical" clinical practice, but no studies have been performed to evaluate safety and efficacy of this treatment schedule.

Condition or disease	Intervention/treatment	Phase
Respiratory Tract Neoplasms; Thymic Neoplasms; Pancreatic Neoplasms; Gastrointestinal Neoplasms; Multiple Endocrine Neoplasia	Drug: Octreotide-LAR	Phase 2

Detailed Description:

The patient population will include the patients with a histologically documented diagnosis of WDNET, defined according to the last WHO Classification criteria for NET of gastro-entero-pancreatic, bronchial, thymic or other origin; and showing tumor progression under a standard dose treatment with LAR (30 mg every 28 days) for at least 6 months. Progressive disease will be defined as increased tumor size according to RECIST definitions.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 28 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Efficacy and Safety of High Dose Regimen of Octreotide LAR in Patients With Neuroendocrine Tumors in Progressive Disease: A Phase II, Open, Multicentric Prospective Study
• Study Start Date: January 2006
• Actual Primary Completion Date: December 2007
• Actual Study Completion Date: December 2008

Arms and Interventions

Arm	Intervention/treatment
Experimental: Octreotide-LAR; Patients will receive every 21 days an injection of octreotide-LAR 30 mg until progression is documented.	Drug: Octreotide-LAR; Octreotide-LAR 30 mg administered every 21 days until progression; Other Names: Sandostatin-LAR; Longastatina-LAR

Outcome Measures

Primary Outcome Measures :

1. Tumor stabilization [ Time Frame: 6 months ]

Secondary Outcome Measures :

1. Symptoms improvement [ Time Frame: 6 months ]
2. Decrease of chromogranin-A [ Time Frame: 6 months ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Well differentiated neuroendocrine tumors in disease progression

Exclusion Criteria:

• Well differentiated neuroendocrine tumors without disease progression
• Patients with intolerance to somatostatin analogues

Contacts and Locations

Locations

Italy

University Federico II of Naples

Naples, Italy, 80131

Sponsors and Collaborators

Federico II University

University of Perugia, Faculty of Medicine, Department of Internal Medicine

University of Genova

University Hospital, Udine, Italy

Investigators

• Principal Investigator: Annamaria Colao, MD, PhD; University Federico II of Naples

More Information

• Responsible Party: Annamaria Colao, Dept of Mol Clin Endocrinol Oncol, University Federico II of Naples
• ClinicalTrials.gov Identifier: NCT00990535
• Other Study ID Numbers: NeuroendoUnit-6
• First Posted: October 7, 2009
• Last Update Posted: October 7, 2009
• Last Verified: October 2009

Keywords provided by Federico II University:

neuroendocrine tumors; octreotide; somatostatin analogues

Additional relevant MeSH terms:

Neoplasms; Neuroendocrine Tumors; Pancreatic Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Endocrine Gland Neoplasms; Multiple Endocrine Neoplasia; Respiratory Tract Neoplasms; Thymus Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Neoplasms by Site; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Gastrointestinal Diseases; Neoplasms, Multiple Primary; Neoplastic Syndromes, Hereditary; Genetic Diseases, Inborn; Thoracic Neoplasms; Respiratory Tract Diseases; Lymphatic Diseases; Octreotide; Gastrointestinal Agents; Antineoplastic Agents, Hormonal; Antineoplastic Agents