High Dose Somatostatin Analogues in Neuroendocrine Tumors

NCT ID: NCT00990535

Last Updated: 2009-10-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2008-12-31

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.

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Octreotide-LAR

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

Group Type: EXPERIMENTAL

Octreotide-LAR

Intervention Type: DRUG

Octreotide-LAR 30 mg administered every 21 days until progression

Interventions

Octreotide-LAR

Octreotide-LAR 30 mg administered every 21 days until progression

Intervention Type: DRUG

Other Intervention Names

Sandostatin-LAR; Longastatina-LAR

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Perugia, Faculty of Medicine, Department of Internal Medicine

OTHER

Sponsor Role: collaborator

University of Genova

OTHER

Sponsor Role: collaborator

University Hospital, Udine, Italy

OTHER

Sponsor Role: collaborator

Federico II University

OTHER

Sponsor Role: lead

Responsible Party

Dept of Mol Clin Endocrinol Oncol, University Federico II of Naples

Principal Investigators

Annamaria Colao, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Federico II of Naples

Locations

University Federico II of Naples

Naples, , Italy

Countries

Italy

Other Identifiers

NeuroendoUnit-6

Identifier Type: -

Identifier Source: org_study_id