Trial record 9 of 15 for:    "multiple endocrine neoplasia"

High Dose Somatostatin Analogues in Neuroendocrine Tumors (HIDONET)

This study has been completed.
Sponsor:
Collaborators:
University of Perugia, Faculty of Medicine, Department of Internal Medicine
University of Genova
University Hospital, Udine, Italy
Information provided by:
Federico II University
ClinicalTrials.gov Identifier:
NCT00990535
First received: October 5, 2009
Last updated: October 6, 2009
Last verified: October 2009
  Purpose

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 Intervention Phase
Respiratory Tract Neoplasms
Thymic Neoplasms
Pancreatic Neoplasms
Gastrointestinal Neoplasms
Multiple Endocrine Neoplasia
Drug: Octreotide-LAR
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Federico II University:

Primary Outcome Measures:
  • Tumor stabilization [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Symptoms improvement [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Decrease of chromogranin-A [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 28
Study Start Date: January 2006
Study Completion Date: December 2008
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
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: NCT00990535

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

No publications provided

Responsible Party: Annamaria Colao, Dept of Mol Clin Endocrinol Oncol, University Federico II of Naples
ClinicalTrials.gov Identifier: NCT00990535     History of Changes
Other Study ID Numbers: NeuroendoUnit-6
Study First Received: October 5, 2009
Last Updated: October 6, 2009
Health Authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Italy: The Italian Medicines Agency

Keywords provided by Federico II University:
neuroendocrine tumors
octreotide
somatostatin analogues

Additional relevant MeSH terms:
Multiple Endocrine Neoplasia
Neoplasms
Neuroendocrine Tumors
Pancreatic Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Endocrine Gland Neoplasms
Respiratory Tract Neoplasms
Thymoma
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
Neoplasms, Complex and Mixed
Lymphatic Diseases
Octreotide
Somatostatin
Gastrointestinal Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014