P:II Above-Label Octreotide-LAR With Insufficiently Controlled Carcinoid Syndrome
Primary Purpose
Neuroendocrine Carcinoma
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Octreotide LAR
Sponsored by
About this trial
This is an interventional treatment trial for Neuroendocrine Carcinoma focused on measuring endocrine system, neuroendocrine tumors, neuroendocrine cancer, metastatic, neuroendocrine, gastrointestinal (GI), high-dose octreotide, flushing, diarrhea, quality of life in patients, disease-related symptoms
Eligibility Criteria
Inclusion Criteria:
- Metastatic neuroendocrine tumors that are considered well or moderately differentiated (or low to intermediate grade). Patients with poorly differentiated neuroendocrine carcinomas or small cell carcinomas are excluded from the study.
- Elevated urine 5-hydroxyindoleacetic acid (5-HIAA)
- More than 2 bowel-movements per day OR more than 4 flushing episodes per week on average
- Patient currently on octreotide LAR 30mg every 3 or 4 weeks (for at least 3 cycles prior to screening)
- Age ≥ 18 years
- Minimum of four weeks since any major surgery, liver-directed therapy (embolization, etc.) or systemic cancer treatment other than octreotide LAR
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2
- Life expectancy > 12 weeks
- Reliable contraception should be maintained throughout the study and for 3 months after study drug discontinuation.
- Signed informed consent to participate in the study must be obtained from patients after they have been fully informed of the nature and potential risks by the investigator (or his/her designee) with the aid of written information.
Exclusion Criteria:
- Known hypersensitivity to somatostatin analogues
- Patients with poorly differentiated neuroendocrine cancers
- Patients with liver cirrhosis
- Patients receiving hemodialysis or peritoneal dialysis
- Patients with cachexia who, in the opinion of the investigator, may have difficulty tolerating intramuscular injection
- Patients with symptomatic cholelithiasis or biliary events within past five years (who have not undergone cholecystectomy)
- Patients with recent history (within 5 years) of pancreatitis
- Patients with uncontrolled diabetes (HgA1c >8.0 despite adequate therapy)
- Women of child-bearing potential, UNLESS they are using two birth control methods
- Women who are pregnant or lactating
- HIV positive patients
- History of sustained ventricular tachycardia, ventricular fibrillation, advanced heart block, idiopathic syncope thought to be related to ventricular arrhythmia, or congenital long QT syndrome
- Risk factors for Torsades de Pointes such as cardiac failure, clinically significant/symptomatic bradycardia
- Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study
- History of noncompliance to medical regimens or unwillingness to comply with the protocol
- Patients who were unable to tolerate or did not benefit from above-label dose octreotide (>30mg) in the past
- Concomitant use of other cancer treatments or carcinoid syndrome treatments (whether standard or experimental). Patients should discontinue any concomitant cancer medications more than two weeks prior to screening.
Sites / Locations
- H. Lee Moffitt Cancer Center and Research Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Octreotide Long-acting Release (LAR)
Arm Description
Octreotide LAR will be administered at a dose of 60 mg intramuscularly (IM) every 4 weeks.
Outcomes
Primary Outcome Measures
Number of Participants With Improved Frequency of Diarrhea
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.
Secondary Outcome Measures
Rate of Progression Free Survival (PFS) 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.
Full Information
NCT ID
NCT01886287
First Posted
June 21, 2013
Last Updated
January 6, 2015
Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Collaborators
Novartis
1. Study Identification
Unique Protocol Identification Number
NCT01886287
Brief Title
P:II Above-Label Octreotide-LAR With Insufficiently Controlled Carcinoid Syndrome
Official Title
Phase II Study of Above-Label Octreotide-LAR in Patients With Insufficiently Controlled Carcinoid Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Terminated
Why Stopped
Slow accrual
Study Start Date
December 2013 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
October 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Collaborators
Novartis
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuroendocrine Carcinoma
Keywords
endocrine system, neuroendocrine tumors, neuroendocrine cancer, metastatic, neuroendocrine, gastrointestinal (GI), high-dose octreotide, flushing, diarrhea, quality of life in patients, disease-related symptoms
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Octreotide Long-acting Release (LAR)
Arm Type
Experimental
Arm Description
Octreotide LAR will be administered at a dose of 60 mg intramuscularly (IM) every 4 weeks.
Intervention Type
Drug
Intervention Name(s)
Octreotide LAR
Other Intervention Name(s)
Sandostatin LAR®
Intervention Description
Octreotide LAR as outlined in Treatment Arm.
Primary Outcome Measure Information:
Title
Number of Participants With Improved Frequency of Diarrhea
Description
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.
Time Frame
At 12 weeks
Secondary Outcome Measure Information:
Title
Rate of Progression Free Survival (PFS) at 6 Months
Description
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.
Time Frame
At 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Metastatic neuroendocrine tumors that are considered well or moderately differentiated (or low to intermediate grade). Patients with poorly differentiated neuroendocrine carcinomas or small cell carcinomas are excluded from the study.
Elevated urine 5-hydroxyindoleacetic acid (5-HIAA)
More than 2 bowel-movements per day OR more than 4 flushing episodes per week on average
Patient currently on octreotide LAR 30mg every 3 or 4 weeks (for at least 3 cycles prior to screening)
Age ≥ 18 years
Minimum of four weeks since any major surgery, liver-directed therapy (embolization, etc.) or systemic cancer treatment other than octreotide LAR
Eastern Cooperative Oncology Group (ECOG) performance status ≤2
Life expectancy > 12 weeks
Reliable contraception should be maintained throughout the study and for 3 months after study drug discontinuation.
Signed informed consent to participate in the study must be obtained from patients after they have been fully informed of the nature and potential risks by the investigator (or his/her designee) with the aid of written information.
Exclusion Criteria:
Known hypersensitivity to somatostatin analogues
Patients with poorly differentiated neuroendocrine cancers
Patients with liver cirrhosis
Patients receiving hemodialysis or peritoneal dialysis
Patients with cachexia who, in the opinion of the investigator, may have difficulty tolerating intramuscular injection
Patients with symptomatic cholelithiasis or biliary events within past five years (who have not undergone cholecystectomy)
Patients with recent history (within 5 years) of pancreatitis
Patients with uncontrolled diabetes (HgA1c >8.0 despite adequate therapy)
Women of child-bearing potential, UNLESS they are using two birth control methods
Women who are pregnant or lactating
HIV positive patients
History of sustained ventricular tachycardia, ventricular fibrillation, advanced heart block, idiopathic syncope thought to be related to ventricular arrhythmia, or congenital long QT syndrome
Risk factors for Torsades de Pointes such as cardiac failure, clinically significant/symptomatic bradycardia
Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study
History of noncompliance to medical regimens or unwillingness to comply with the protocol
Patients who were unable to tolerate or did not benefit from above-label dose octreotide (>30mg) in the past
Concomitant use of other cancer treatments or carcinoid syndrome treatments (whether standard or experimental). Patients should discontinue any concomitant cancer medications more than two weeks prior to screening.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan Strosberg, M.D.
Organizational Affiliation
H. Lee Moffitt Cancer Center and Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
H. Lee Moffitt Cancer Center and Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
12. IPD Sharing Statement
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P:II Above-Label Octreotide-LAR With Insufficiently Controlled Carcinoid Syndrome
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