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

Inclusion Criteria:

• Metastatic neuroendocrine tumors that are considered well or moderately differentiated (or low to intermediate grade). Patients with poorly differentiated neuroendocrine carcinomas or small cell carcinomas are excluded from the study.
• Elevated urine 5-hydroxyindoleacetic acid (5-HIAA)
• More than 2 bowel-movements per day OR more than 4 flushing episodes per week on average
• Patient currently on octreotide LAR 30mg every 3 or 4 weeks (for at least 3 cycles prior to screening)
• Age ≥ 18 years
• Minimum of four weeks since any major surgery, liver-directed therapy (embolization, etc.) or systemic cancer treatment other than octreotide LAR
• Eastern Cooperative Oncology Group (ECOG) performance status ≤2
• Life expectancy > 12 weeks
• Reliable contraception should be maintained throughout the study and for 3 months after study drug discontinuation.
• Signed informed consent to participate in the study must be obtained from patients after they have been fully informed of the nature and potential risks by the investigator (or his/her designee) with the aid of written information.

Exclusion Criteria:

• Known hypersensitivity to somatostatin analogues
• Patients with poorly differentiated neuroendocrine cancers
• Patients with liver cirrhosis
• Patients receiving hemodialysis or peritoneal dialysis
• Patients with cachexia who, in the opinion of the investigator, may have difficulty tolerating intramuscular injection
• Patients with symptomatic cholelithiasis or biliary events within past five years (who have not undergone cholecystectomy)
• Patients with recent history (within 5 years) of pancreatitis
• Patients with uncontrolled diabetes (HgA1c >8.0 despite adequate therapy)
• Women of child-bearing potential, UNLESS they are using two birth control methods
• Women who are pregnant or lactating
• HIV positive patients
• History of sustained ventricular tachycardia, ventricular fibrillation, advanced heart block, idiopathic syncope thought to be related to ventricular arrhythmia, or congenital long QT syndrome
• Risk factors for Torsades de Pointes such as cardiac failure, clinically significant/symptomatic bradycardia
• Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study
• History of noncompliance to medical regimens or unwillingness to comply with the protocol
• Patients who were unable to tolerate or did not benefit from above-label dose octreotide (>30mg) in the past
• Concomitant use of other cancer treatments or carcinoid syndrome treatments (whether standard or experimental). Patients should discontinue any concomitant cancer medications more than two weeks prior to screening.