P:II Above-Label Octreotide-LAR With Insufficiently Controlled Carcinoid Syndrome
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.
|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|
- Frequency of Symptoms [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]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.
- Rate of Progression Free Survival (PFS) [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]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.
|Study Start Date:||December 2013|
|Estimated Study Completion Date:||April 2018|
|Estimated Primary Completion Date:||April 2018 (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.
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute||Recruiting|
|Tampa, Florida, United States, 33612|
|Contact: Tiffany Campos 813-745-8358 firstname.lastname@example.org|
|Principal Investigator: Jonathan Strosberg, M.D.|
|Sub-Investigator: Khaldoun Almhanna, M.D.|
|Sub-Investigator: Gregory Springett, M.D., Ph.D.|
|Principal Investigator:||Jonathan Strosberg, M.D.||H. Lee Moffitt Cancer Center and Research Institute|