High Dose Somatostatin Analogues in Neuroendocrine Tumors

NCT00990535 | Completed Phase 2 DMC

• 1 other identifier: NeuroendoUnit-6
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Tract Neoplasms; Thymic Neoplasms; Pancreatic Neoplasms; Gastrointestinal Neoplasms; Multiple Endocrine Neoplasia

Keywords

neuroendocrine tumors; octreotide; somatostatin analogues

Outcome Measures

Primary Outcomes (1)

• Tumor stabilization

  6 months

Secondary Outcomes (2)

• Symptoms improvement

  6 months

• Decrease of chromogranin-A

  6 months

Study Arms (1)

Octreotide-LAR

EXPERIMENTAL

Patients will receive every 21 days an injection of octreotide-LAR 30 mg until progression is documented.

Drug: Octreotide-LAR

Interventions

Octreotide-LAR DRUG

Octreotide-LAR 30 mg administered every 21 days until progression

Also known as: Sandostatin-LAR, Longastatina-LAR

Octreotide-LAR

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Well differentiated neuroendocrine tumors in disease progression

You may not qualify if:

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

Sponsors & Collaborators

• Federico II University: lead
• University of Perugia, Faculty of Medicine, Department of Internal Medicine: collaborator
• University of Genova: collaborator
• University Hospital, Udine, Italy: collaborator

Study Sites (1)

University Federico II of Naples

Naples, 80131, Italy

Location

MeSH Terms

Conditions

Respiratory Tract Neoplasms; Thymus Neoplasms; Pancreatic Neoplasms; Gastrointestinal Neoplasms; Multiple Endocrine Neoplasia; Neuroendocrine Tumors

Condition Hierarchy (Ancestors)

Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lymphatic Diseases; Hemic and Lymphatic Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Gastrointestinal Diseases; Neoplasms, Multiple Primary; Neoplastic Syndromes, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue

Study Officials

• Annamaria Colao, MD, PhD

  University Federico II of Naples

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 5, 2009
• First Posted: October 7, 2009
• Study Start: January 1, 2006
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2008
• Last Updated: October 7, 2009

Record last verified: 2009-10

Locations

IT (1)