P:II Above-Label Octreotide-LAR With Insufficiently Controlled Carcinoid Syndrome
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Above-Label Octreotide-LAR in Patients With Insufficiently Controlled Carcinoid Syndrome|
- Number of Participants With Improved Frequency of Diarrhea [ Time Frame: At 12 weeks ] [ Designated as safety issue: No ]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.
- Rate of Progression Free Survival (PFS) at 6 Months [ Time Frame: At 6 months ] [ Designated as safety issue: No ]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.
|Study Start Date:||December 2013|
|Study Completion Date:||October 2014|
|Primary Completion Date:||August 2014 (Final data collection date for primary outcome measure)|
Experimental: Octreotide Long-acting Release (LAR)
Octreotide LAR will be administered at a dose of 60 mg intramuscularly (IM) every 4 weeks.
Drug: Octreotide LAR
Octreotide LAR as outlined in Treatment Arm.
Other Name: Sandostatin LAR®
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01886287
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute|
|Tampa, Florida, United States, 33612|
|Principal Investigator:||Jonathan Strosberg, M.D.||H. Lee Moffitt Cancer Center and Research Institute|