Conditions: Neuroendocrine Carcinoma
Keywords: endocrine system neuroendocrine tumors neuroendocrine cancer metastatic neuroendocrine gastrointestinal (GI) high-dose octreotide flushing diarrhea quality of life in patients disease-related symptoms
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 2
Healthy volunteers: no

Brief 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.

Detailed 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.

Arms:
arm 1: Octreotide LAR will be administered at a dose of 60 mg intramuscularly (IM) every 4 weeks.

Interventions: intervention 1: Octreotide LAR
Intervention descriptions: intervention 1: Octreotide LAR as outlined in Treatment Arm.

Protocol document: