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

This study is currently recruiting participants.
Verified December 2013 by H. Lee Moffitt Cancer Center and Research Institute
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier:
NCT01886287
First received: June 21, 2013
Last updated: December 23, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Neuroendocrine Carcinoma
Drug: Octreotide LAR
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by H. Lee Moffitt Cancer Center and Research Institute:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 30
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)
Arms Assigned Interventions
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®

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01886287

Locations
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute Recruiting
Tampa, Florida, United States, 33612
Contact: Tiffany Campos    813-745-8358    tiffany.campos@moffitt.org   
Principal Investigator: Jonathan Strosberg, M.D.         
Sub-Investigator: Khaldoun Almhanna, M.D.         
Sub-Investigator: Gregory Springett, M.D., Ph.D.         
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
Novartis
Investigators
Principal Investigator: Jonathan Strosberg, M.D. H. Lee Moffitt Cancer Center and Research Institute
  More Information

Additional Information:
No publications provided

Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT01886287     History of Changes
Other Study ID Numbers: MCC-17410, CSMS995AUS64T
Study First Received: June 21, 2013
Last Updated: December 23, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:
endocrine system
neuroendocrine tumors
neuroendocrine cancer
metastatic
neuroendocrine
gastrointestinal (GI)
high-dose octreotide
flushing
diarrhea
quality of life in patients
disease-related symptoms

Additional relevant MeSH terms:
Malignant Carcinoid Syndrome
Serotonin Syndrome
Carcinoid Tumor
Carcinoma
Carcinoma, Neuroendocrine
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Drug Toxicity
Poisoning
Substance-Related Disorders
Octreotide
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Gastrointestinal Agents

ClinicalTrials.gov processed this record on April 17, 2014