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

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ClinicalTrials.gov Identifier: NCT00171873
Recruitment Status : Unknown
Verified May 2012 by Carmen Schade-Brittinger, Philipps University Marburg Medical Center.
Recruitment status was:  Active, not recruiting
First Posted : September 15, 2005
Results First Posted : March 28, 2011
Last Update Posted : May 10, 2012
Sponsor:
Information provided by (Responsible Party):
Carmen Schade-Brittinger, Philipps University Marburg Medical Center

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

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 85 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : September 2001
Primary Completion Date : June 2008
Estimated Study Completion Date : December 2013


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 Name: SMS995
Placebo Comparator: Placebo
Placebo - Sodium chloride intramuscularly every 28 days
Drug: Placebo
Sodium chloride intramuscularly every 28 days



Primary Outcome Measures :
  1. 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.


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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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, 35033
Novartis Investigative Site
Marburg, Germany
Novartis Investigative Site
Munchen, Germany
Sponsors and Collaborators
Carmen Schade-Brittinger
Investigators
Principal Investigator: Rudolf Arnold, MD, Prof Philipps University Marburg Medical Center

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
First Posted: September 15, 2005    Key Record Dates
Results First Posted: March 28, 2011
Last Update Posted: May 10, 2012
Last Verified: May 2012

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

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