Antiproliferative Effect of Octreotide in Patients With Metastasized Neuroendocrine Tumors of the Midgut

March 16, 2020 updated by: Carmen Schade-Brittinger

Study to Investigate the Antiproliferative Effect of Octreotide in Patients With Metastasized Neuroendocrine Tumors of the Midgut

Placebo-controlled prospective randomized phase III study to investigate the antiproliferative effect of octreotide in patients with metastasized neuroendocrine tumors of the midgut

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

85

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bochum, Germany
        • Novartis Investigative Site
      • Dresden, Germany
        • Novartis Investigative Site
      • Halle, Germany
        • Novartis Investigative Site
      • Hamburg, Germany
        • Novartis Investigative Site
      • Kiel, Germany
        • Novartis Investigative Site
      • Leipzig, Germany
        • Novartis Investigative Site
      • Mainz, Germany
        • Novartis Investigative Site
      • Marburg, Germany
        • Novartis Investigative Site
      • Marburg, Germany, 35033
        • Novartis Investigative Site
      • Munchen, Germany
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Therapy-naive patients with histologically confirmed diagnosis of a locally inoperable or metastasized well-differentiated neuroendocrine tumor of the midgut
  • curative surgery impossible
  • two-dimensional tumor formation assessable by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI)
  • Age ≥ 18
  • Karnofsky-index > 60
  • written informed consent
  • proliferation index for Ki67

Exclusion Criteria:

  • hypersensitivity to octreotide
  • poorly differentiated or small cell neuroendocrine tumors
  • primary tumor outside of the midgut
  • prior treatment with somatostatin-analogue > 4 weeks
  • prior treatment with alpha-interferon, chemotherapy, or chemoembolisation
  • participation in any other clinical trial
  • pregnancy or lactation
  • no secondary malignancy in anamnesis; with the exception of patients without any manifestation of the secondary malignancy (without relapse) after curative therapy within the last five years
  • severe decompensated organ malfunction (heart-, liver- insufficiency)

Other protocol-defined exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Octreotide LAR (Long Acting Release)
Octreotide LAR 30 mg intramuscularly every 28 days
Drug: Octreotide LAR (Long-acting release)
30 mg intramuscularly every 28 days
Other Names:
  • SMS995
Placebo Comparator: Placebo
Placebo - Sodium chloride intramuscularly every 28 days
Drug: Placebo
Sodium chloride intramuscularly every 28 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Tumor Progression Documented by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI)
Time Frame: Up to 7 years
Median time to tumor progression at the time of the planned interim analysis that includes all data observed until June 2008.
Up to 7 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Objective Response Rates According to World Health Organization (WHO) Criteria at 3 Month Intervals
Time Frame: at 3 month intervals
at 3 month intervals
Biochemical Response at 3 Month Intervals
Time Frame: at 3 month intervals up to 18 moths
at 3 month intervals up to 18 moths
Symptom Control at 3 Month Intervals
Time Frame: at 3 month intervals up to 18 moths
at 3 month intervals up to 18 moths
Quality of Life (Standardized Questionnaire) at Three-month Intervals in Comparison With the Start of the Study
Time Frame: at three-month intervals
at three-month intervals
Survival
Time Frame: at least on a monthly basis
at least on a monthly basis

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Carmen Schade-Brittinger

Investigators

  • Principal Investigator: Rudolf Arnold, MD, Prof, Philipps University Marburg Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2001

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 15, 2005

Study Record Updates

Last Update Posted (Actual)

March 26, 2020

Last Update Submitted That Met QC Criteria

March 16, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSMS995ADE05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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