Clinical Trial: P:II Above-Label Octreotide-LAR With Insufficiently Controlled Carcinoid Syndrome
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: Phase II Study of Above-Label Octreotide-LAR in Patients With Insufficiently Controlled Carcinoid Syndrome
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 Summary:
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.
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
Current Primary Outcome: Number of Participants With Improved Frequency of Diarrhea [ Time Frame: At 12 weeks ]
Original Primary Outcome: Frequency of Symptoms [ Time Frame: Up to 5 years ]
Current Secondary Outcome: Rate of Progression Free Survival (PFS) at 6 Months [ Time Frame: At 6 months ]
Original Secondary Outcome: Rate of Progression Free Survival (PFS) [ Time Frame: Up to 5 years ]
Information By: H. Lee Moffitt Cancer Center and Research Institute
Dates:
Date Received: June 21, 2013
Date Started: December 2013
Date Completion:
Last Updated: January 6, 2015
Last Verified: January 2015