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 ]

The frequencies of flushing, diarrhea, and carcinoid syndrome control rating (scale 1-5) will be measured and compared at week 0 and week 12 . These measurements will be compared using two-sided non-parametric paired Wilcoxon signed-rank.


Original Primary Outcome: Frequency of Symptoms [ Time Frame: Up to 5 years ]

The frequencies of flushing, diarrhea, and carcinoid syndrome control rating (scale 1-5) will be measured and compared. These measurements will be compared using two-sided non-parametric paired Wilcoxon signed-rank test controlling type I error at 0.05 based on 2000 Monte Carlo simulations.


Current Secondary Outcome: Rate of Progression Free Survival (PFS) at 6 Months [ Time Frame: At 6 months ]

Progression-free survival, defined as rate of patients alive and free of progression from the date of first study treatment to the end of trial at 6 months. Progressive disease (PD): at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions.


Original Secondary Outcome: Rate of Progression Free Survival (PFS) [ Time Frame: Up to 5 years ]

Progression-free survival, defined as the time from the date of first study treatment to the date of the first documented disease progression, by Response Evaluation Criteria in Solid Tumors (RECIST 1.1) or death due to any cause. Progressive disease (PD): at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions.


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