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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


Phase 2
18 Years
80 Years
Not Enrolling
Both
Respiratory Tract Neoplasms, Thymic Neoplasms, Pancreatic Neoplasms, Gastrointestinal Neoplasms, Multiple Endocrine Neoplasia

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Trial Information

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


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.


Inclusion Criteria:



- Well differentiated neuroendocrine tumors in disease progression

Exclusion Criteria:

- Well differentiated neuroendocrine tumors without disease progression

- Patients with intolerance to somatostatin analogues

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Tumor stabilization

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

Annamaria Colao, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Federico II of Naples

Authority:

Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Study ID:

NeuroendoUnit-6

NCT ID:

NCT00990535

Start Date:

January 2006

Completion Date:

December 2008

Related Keywords:

  • Respiratory Tract Neoplasms
  • Thymic Neoplasms
  • Pancreatic Neoplasms
  • Gastrointestinal Neoplasms
  • Multiple Endocrine Neoplasia
  • neuroendocrine tumors
  • octreotide
  • somatostatin analogues
  • Neoplasms
  • Endocrine Gland Neoplasms
  • Gastrointestinal Neoplasms
  • Digestive System Neoplasms
  • Multiple Endocrine Neoplasia
  • Pancreatic Neoplasms
  • Respiratory Tract Neoplasms
  • Thymus Neoplasms
  • Neuroendocrine Tumors

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