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

• Status: Terminated
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute
• Collaborator: Novartis
• Treatments: Octreotide

Criteria

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.