High Dose Somatostatin Analogues in Neuroendocrine Tumors (HIDONET)
Primary Purpose
Respiratory Tract Neoplasms, Thymic Neoplasms, Pancreatic Neoplasms
Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Octreotide-LAR
Sponsored by
About this trial
This is an interventional treatment trial for Respiratory Tract Neoplasms focused on measuring neuroendocrine tumors, octreotide, somatostatin analogues
Eligibility 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
Sites / Locations
- University Federico II of Naples
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Octreotide-LAR
Arm Description
Patients will receive every 21 days an injection of octreotide-LAR 30 mg until progression is documented.
Outcomes
Primary Outcome Measures
Tumor stabilization
Secondary Outcome Measures
Symptoms improvement
Decrease of chromogranin-A
Full Information
NCT ID
NCT00990535
First Posted
October 5, 2009
Last Updated
October 6, 2009
Sponsor
Federico II University
Collaborators
University of Perugia, Faculty of Medicine, Department of Internal Medicine, University of Genova, University Hospital, Udine, Italy
1. Study Identification
Unique Protocol Identification Number
NCT00990535
Brief Title
High Dose Somatostatin Analogues in Neuroendocrine Tumors
Acronym
HIDONET
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 Type
Interventional
2. Study Status
Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Federico II University
Collaborators
University of Perugia, Faculty of Medicine, Department of Internal Medicine, University of Genova, University Hospital, Udine, Italy
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Tract Neoplasms, Thymic Neoplasms, Pancreatic Neoplasms, Gastrointestinal Neoplasms, Multiple Endocrine Neoplasia
Keywords
neuroendocrine tumors, octreotide, somatostatin analogues
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Octreotide-LAR
Arm Type
Experimental
Arm Description
Patients will receive every 21 days an injection of octreotide-LAR 30 mg until progression is documented.
Intervention Type
Drug
Intervention Name(s)
Octreotide-LAR
Other Intervention Name(s)
Sandostatin-LAR, Longastatina-LAR
Intervention Description
Octreotide-LAR 30 mg administered every 21 days until progression
Primary Outcome Measure Information:
Title
Tumor stabilization
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Symptoms improvement
Time Frame
6 months
Title
Decrease of chromogranin-A
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Annamaria Colao, MD, PhD
Organizational Affiliation
University Federico II of Naples
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Federico II of Naples
City
Naples
ZIP/Postal Code
80131
Country
Italy
12. IPD Sharing Statement
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High Dose Somatostatin Analogues in Neuroendocrine Tumors
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