Back to results

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

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

Time Frame

At 12 weeks

Secondary Outcome Measure Information:

Title

Rate of Progression Free Survival (PFS) at 6 Months

Description

Time Frame

At 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Learn more about this trial

P:II Above-Label Octreotide-LAR With Insufficiently Controlled Carcinoid Syndrome

We'll reach out to this number within 24 hrs