P:II Above-Label Octreotide-LAR With Insufficiently Controlled Carcinoid Syndrome
|ClinicalTrials.gov Identifier: NCT01886287|
Recruitment Status : Terminated (Slow accrual)
First Posted : June 25, 2013
Results First Posted : January 12, 2015
Last Update Posted : January 12, 2015
|Condition or disease||Intervention/treatment||Phase|
|Neuroendocrine Carcinoma||Drug: Octreotide LAR||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Above-Label Octreotide-LAR in Patients With Insufficiently Controlled Carcinoid Syndrome|
|Study Start Date :||December 2013|
|Actual Primary Completion Date :||August 2014|
|Actual Study Completion Date :||October 2014|
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®
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|