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Trial · Interventional

TerminatedPhase 2Results postedRegistry data

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

NCTNCT01886287 (opens ClinicalTrials.gov in a new tab)Other idMCC-17410Other idCSMS995AUS64T

Overview

Status
Terminated
Phase
Phase 2
Enrollment
2 participants (actual)
Sponsor
H. Lee Moffitt Cancer Center and Research Institute · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
Dec 2013
Primary completion
Aug 2014
Completion
Oct 2014
First posted
25 Jun 2013 (estimated)
Last update posted
12 Jan 2015 (estimated)
Conditions
Neuroendocrine Carcinoma

Timeline

1 trial · 1 stopped early · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201320142015
  1. Ph 2

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

    NCT01886287

    Dec 2013 to Oct 2014

    Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Octreotide LARDrug

Arms1

  • Experimental

    Octreotide Long-acting Release (LAR)

    Octreotide LAR will be administered at a dose of 60 mg intramuscularly (IM) every 4 weeks.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Number of Participants With Improved Frequency of Diarrhea

    Time frame · At 12 weeks

    Registry 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.

Secondary outcomes(1)
  1. Rate of Progression Free Survival (PFS) at 6 Months

    Time frame · At 6 months

    Registry 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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· At 12 weeks

Number of Participants With Improved Frequency of Diarrhea

GroupValue (participants)
Octreotide Long-acting Release (LAR)1
Secondary and other outcome results(1)
Secondary outcome· At 6 months

Rate of Progression Free Survival (PFS) at 6 Months

GroupValue
Octreotide Long-acting Release (LAR)not posted

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Octreotide Long-acting Release (LAR)Octreotide LAR will be administered at a dose of 60 mg intramuscularly (IM) every 4 weeks. Octreotide LAR: Octreotide LAR as outlined in Treatment Arm.–0 / 22 / 2

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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