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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

October 5, 2009
October 6, 2009
January 2006
December 2007   (final data collection date for primary outcome measure)
Tumor stabilization [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00990535 on ClinicalTrials.gov Archive Site
  • Symptoms improvement [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Decrease of chromogranin-A [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
High Dose Somatostatin Analogues in Neuroendocrine Tumors
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

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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Respiratory Tract Neoplasms
  • Thymic Neoplasms
  • Pancreatic Neoplasms
  • Gastrointestinal Neoplasms
  • Multiple Endocrine Neoplasia
Drug: Octreotide-LAR
Octreotide-LAR 30 mg administered every 21 days until progression
Other Names:
  • Sandostatin-LAR
  • Longastatina-LAR
Experimental: Octreotide-LAR
Patients will receive every 21 days an injection of octreotide-LAR 30 mg until progression is documented.
Intervention: Drug: Octreotide-LAR
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
December 2008
December 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Well differentiated neuroendocrine tumors in disease progression

Exclusion Criteria:

  • Well differentiated neuroendocrine tumors without disease progression
  • Patients with intolerance to somatostatin analogues
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00990535
NeuroendoUnit-6
Yes
Annamaria Colao, Dept of Mol Clin Endocrinol Oncol, University Federico II of Naples
Federico II University
  • University of Perugia, Faculty of Medicine, Department of Internal Medicine
  • University of Genova
  • University Hospital, Udine, Italy
Principal Investigator: Annamaria Colao, MD, PhD University Federico II of Naples
Federico II University
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP