P:II Above-Label Octreotide-LAR With Insufficiently Controlled Carcinoid Syndrome

Neuroendocrine Carcinoma Clinical Trial

Official title: Phase II Study of Above-Label Octreotide-LAR in Patients With Insufficiently Controlled Carcinoid Syndrome

Status Terminated

Clinical Trial Summary

The primary purpose of the study is to investigate the effects of high-dose octreotide on flushing, diarrhea, and quality of life in patients whose disease-related symptoms are inadequately controlled by the maximum approved dose of octreotide LAR.

Clinical Trial Description

The study population will consist of patients with advanced (metastatic or unresectable) neuroendocrine tumors with suboptimally controlled carcinoid syndrome. While the majority of patients will have primary tumors of the ileocecum (midgut), any serotonin-producing neuroendocrine tumors will be eligible (including pancreatic, lung and unknown primary).

All patients will be followed for adverse events and serious adverse events for 28 days following the last dose of above-label octreotide, or until resolution or stabilization of the event, whichever comes first. ;

Study Design

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

Related Conditions & MeSH terms

• Carcinoma, Neuroendocrine
• Malignant Carcinoid Syndrome
• Neuroendocrine Carcinoma
• Serotonin Syndrome

• NCT number: NCT01886287
• Study type: Interventional
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Status: Terminated
• Phase: Phase 2
• Start date: December 2013
• Completion date: October 2014