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Trial record 4 of 4 for:    "Thymoma" | "Octreotide"

High Dose Somatostatin Analogues in Neuroendocrine Tumors (HIDONET)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00990535
Recruitment Status : Completed
First Posted : October 7, 2009
Last Update Posted : October 7, 2009
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

Tracking Information
First Submitted Date  ICMJE October 5, 2009
First Posted Date  ICMJE October 7, 2009
Last Update Posted Date October 7, 2009
Study Start Date  ICMJE January 2006
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 6, 2009)
Tumor stabilization [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 6, 2009)
  • Symptoms improvement [ Time Frame: 6 months ]
  • Decrease of chromogranin-A [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE High Dose Somatostatin Analogues in Neuroendocrine Tumors
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Respiratory Tract Neoplasms
  • Thymic Neoplasms
  • Pancreatic Neoplasms
  • Gastrointestinal Neoplasms
  • Multiple Endocrine Neoplasia
Intervention  ICMJE Drug: Octreotide-LAR
Octreotide-LAR 30 mg administered every 21 days until progression
Other Names:
  • Sandostatin-LAR
  • Longastatina-LAR
Study Arms  ICMJE Experimental: Octreotide-LAR
Patients will receive every 21 days an injection of octreotide-LAR 30 mg until progression is documented.
Intervention: Drug: Octreotide-LAR
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 6, 2009)
28
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2008
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Well differentiated neuroendocrine tumors in disease progression

Exclusion Criteria:

  • Well differentiated neuroendocrine tumors without disease progression
  • Patients with intolerance to somatostatin analogues
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00990535
Other Study ID Numbers  ICMJE NeuroendoUnit-6
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Annamaria Colao, Dept of Mol Clin Endocrinol Oncol, University Federico II of Naples
Study Sponsor  ICMJE Federico II University
Collaborators  ICMJE
  • University of Perugia, Faculty of Medicine, Department of Internal Medicine
  • University of Genova
  • University Hospital, Udine, Italy
Investigators  ICMJE
Principal Investigator: Annamaria Colao, MD, PhD University Federico II of Naples
PRS Account Federico II University
Verification Date October 2009

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