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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Carmen Schade-Brittinger, Philipps University Marburg Medical Center
ClinicalTrials.gov Identifier:
NCT00171873
First received: September 13, 2005
Last updated: May 8, 2012
Last verified: May 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Neuroendocrine Tumors
 Drug: Octreotide LAR (Long-acting release)
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study to Investigate the Antiproliferative Effect of Octreotide in Patients With Metastasized Neuroendocrine Tumors of the Midgut

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Philipps University Marburg Medical Center:

Primary Outcome Measures:
  • Time to Tumor Progression Documented by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) [ Time Frame: Up to 7 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: at 3 month intervals ] [ Designated as safety issue: No ]
  • Biochemical Response at 3 Month Intervals [ Time Frame: at 3 month intervals up to 18 moths ] [ Designated as safety issue: No ]
  • Symptom Control at 3 Month Intervals [ Time Frame: at 3 month intervals up to 18 moths ] [ Designated as safety issue: No ]
  • Quality of Life (Standardized Questionnaire) at Three-month Intervals in Comparison With the Start of the Study [ Time Frame: at three-month intervals ] [ Designated as safety issue: No ]
  • Survival [ Time Frame: at least on a monthly basis ] [ Designated as safety issue: Yes ]

Enrollment: 85
Study Start Date: September 2001
Estimated Study Completion Date: December 2013
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: SMS995
Placebo Comparator: Placebo
Placebo - Sodium chloride intramuscularly every 28 days
 Drug: Placebo
Sodium chloride intramuscularly every 28 days

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00171873

Locations
Germany
Novartis Investigative Site
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
Sponsors and Collaborators
Carmen Schade-Brittinger
Investigators
Principal Investigator: Rudolf Arnold, MD, Prof Philipps University Marburg Medical Center
  More Information

No publications provided by Philipps University Marburg Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Carmen Schade-Brittinger, Sponsor-representative, Philipps University Marburg Medical Center
ClinicalTrials.gov Identifier: NCT00171873     History of Changes
Obsolete Identifiers: NCT00202085
Other Study ID Numbers: CSMS995ADE05
Study First Received: September 13, 2005
Results First Received: February 28, 2011
Last Updated: May 8, 2012
Health Authority: European Union: European Medicines Agency
Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Philipps University Marburg Medical Center:
Double blind
Phase III
Disease
Clinical trial
Octreotide
 Neuroendocrine tumor
Cancer
Tumor
Midgut

Additional relevant MeSH terms:
Neoplasm Metastasis
Neuroendocrine Tumors
Neoplastic Processes
Neoplasms
Pathologic Processes
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
 Neoplasms, Nerve Tissue
Octreotide
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Gastrointestinal Agents

ClinicalTrials.gov processed this record on June 18, 2013