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

Primary Purpose

Neuroendocrine Tumors

Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Octreotide LAR (Long-acting release)
Placebo
Sponsored by
Carmen Schade-Brittinger
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuroendocrine Tumors focused on measuring Double blind, Phase III, Disease, Clinical trial, Octreotide, Neuroendocrine tumor, Cancer, Tumor, Midgut

Eligibility Criteria

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

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.

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Octreotide LAR (Long Acting Release)

Placebo

Arm Description

Octreotide LAR 30 mg intramuscularly every 28 days

Placebo - Sodium chloride intramuscularly every 28 days

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Objective Response Rates According to World Health Organization (WHO) Criteria at 3 Month Intervals
Biochemical Response at 3 Month Intervals
Symptom Control at 3 Month Intervals
Quality of Life (Standardized Questionnaire) at Three-month Intervals in Comparison With the Start of the Study
Survival

Full Information

First Posted
September 13, 2005
Last Updated
March 16, 2020
Sponsor
Carmen Schade-Brittinger
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1. Study Identification

Unique Protocol Identification Number
NCT00171873
Brief Title
Antiproliferative Effect of Octreotide in Patients With Metastasized Neuroendocrine Tumors of the Midgut
Official Title
Study to Investigate the Antiproliferative Effect of Octreotide in Patients With Metastasized Neuroendocrine Tumors of the Midgut
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
September 2001 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Carmen Schade-Brittinger

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuroendocrine Tumors
Keywords
Double blind, Phase III, Disease, Clinical trial, Octreotide, Neuroendocrine tumor, Cancer, Tumor, Midgut

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
85 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Octreotide LAR (Long Acting Release)
Arm Type
Experimental
Arm Description
Octreotide LAR 30 mg intramuscularly every 28 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo - Sodium chloride intramuscularly every 28 days
Intervention Type
Drug
Intervention Name(s)
Octreotide LAR (Long-acting release)
Other Intervention Name(s)
SMS995
Intervention Description
30 mg intramuscularly every 28 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Sodium chloride intramuscularly every 28 days
Primary Outcome Measure Information:
Title
Time to Tumor Progression Documented by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI)
Description
Median time to tumor progression at the time of the planned interim analysis that includes all data observed until June 2008.
Time Frame
Up to 7 years
Secondary Outcome Measure Information:
Title
Objective Response Rates According to World Health Organization (WHO) Criteria at 3 Month Intervals
Time Frame
at 3 month intervals
Title
Biochemical Response at 3 Month Intervals
Time Frame
at 3 month intervals up to 18 moths
Title
Symptom Control at 3 Month Intervals
Time Frame
at 3 month intervals up to 18 moths
Title
Quality of Life (Standardized Questionnaire) at Three-month Intervals in Comparison With the Start of the Study
Time Frame
at three-month intervals
Title
Survival
Time Frame
at least on a monthly basis

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rudolf Arnold, MD, Prof
Organizational Affiliation
Philipps University Marburg Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Novartis Investigative Site
City
Bochum
Country
Germany
Facility Name
Novartis Investigative Site
City
Dresden
Country
Germany
Facility Name
Novartis Investigative Site
City
Halle
Country
Germany
Facility Name
Novartis Investigative Site
City
Hamburg
Country
Germany
Facility Name
Novartis Investigative Site
City
Kiel
Country
Germany
Facility Name
Novartis Investigative Site
City
Leipzig
Country
Germany
Facility Name
Novartis Investigative Site
City
Mainz
Country
Germany
Facility Name
Novartis Investigative Site
City
Marburg
ZIP/Postal Code
35033
Country
Germany
Facility Name
Novartis Investigative Site
City
Marburg
Country
Germany
Facility Name
Novartis Investigative Site
City
Munchen
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
19704057
Citation
Rinke A, Muller HH, Schade-Brittinger C, Klose KJ, Barth P, Wied M, Mayer C, Aminossadati B, Pape UF, Blaker M, Harder J, Arnold C, Gress T, Arnold R; PROMID Study Group. Placebo-controlled, double-blind, prospective, randomized study on the effect of octreotide LAR in the control of tumor growth in patients with metastatic neuroendocrine midgut tumors: a report from the PROMID Study Group. J Clin Oncol. 2009 Oct 1;27(28):4656-63. doi: 10.1200/JCO.2009.22.8510. Epub 2009 Aug 24.
Results Reference
derived

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

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