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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

September 13, 2005
May 8, 2012
September 2001
June 2008   (final data collection date for primary outcome measure)
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.
Not Provided
Complete list of historical versions of study NCT00171873 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
Not Provided
 
Study to Investigate the Antiproliferative Effect of Octreotide in Patients With Metastasized Neuroendocrine Tumors of the Midgut
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
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Neuroendocrine Tumors
  • Drug: Octreotide LAR (Long-acting release)
    30 mg intramuscularly every 28 days
    Other Name: SMS995
  • Drug: Placebo
    Sodium chloride intramuscularly every 28 days
  • Experimental: Octreotide LAR (Long Acting Release)
    Octreotide LAR 30 mg intramuscularly every 28 days
    Intervention: Drug: Octreotide LAR (Long-acting release)
  • Placebo Comparator: Placebo
    Placebo - Sodium chloride intramuscularly every 28 days
    Intervention: Drug: Placebo
Rinke A, Müller HH, Schade-Brittinger C, Klose KJ, Barth P, Wied M, Mayer C, Aminossadati B, Pape UF, Bläker 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. Epub 2009 Aug 24.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
85
December 2013
June 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00171873
CSMS995ADE05
Not Provided
Carmen Schade-Brittinger, Philipps University Marburg Medical Center
Carmen Schade-Brittinger
Not Provided
Principal Investigator: Rudolf Arnold, MD, Prof Philipps University Marburg Medical Center
Philipps University Marburg Medical Center
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP