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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

Tracking Information
First Submitted Date  ICMJE September 13, 2005
First Posted Date  ICMJE September 15, 2005
Results First Submitted Date  ICMJE February 28, 2011
Results First Posted Date  ICMJE March 28, 2011
Last Update Posted Date May 10, 2012
Study Start Date  ICMJE September 2001
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 15, 2011)
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.
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00171873 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 15, 2011)
  • Objective Response Rates According to World Health Organization (WHO) Criteria at 3 Month Intervals [ Time Frame: at 3 month intervals ]
  • Biochemical Response at 3 Month Intervals [ Time Frame: at 3 month intervals up to 18 moths ]
  • Symptom Control at 3 Month Intervals [ Time Frame: 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 ]
  • Survival [ Time Frame: at least on a monthly basis ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Investigate the Antiproliferative Effect of Octreotide in Patients With Metastasized Neuroendocrine Tumors of the Midgut
Official Title  ICMJE Study to Investigate the Antiproliferative Effect of Octreotide in Patients With Metastasized Neuroendocrine Tumors of the Midgut
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Neuroendocrine Tumors
Intervention  ICMJE
  • Drug: Octreotide LAR (Long-acting release)
    30 mg intramuscularly every 28 days
    Other Name: SMS995
  • Drug: Placebo
    Sodium chloride intramuscularly every 28 days
Study Arms  ICMJE
  • 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
Publications * 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. doi: 10.1200/JCO.2009.22.8510. Epub 2009 Aug 24.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: February 17, 2011)
85
Original Enrollment  ICMJE Not Provided
Estimated Study Completion Date  ICMJE December 2013
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00171873
Other Study ID Numbers  ICMJE CSMS995ADE05
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Carmen Schade-Brittinger, Philipps University Marburg Medical Center
Study Sponsor  ICMJE Carmen Schade-Brittinger
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Rudolf Arnold, MD, Prof Philipps University Marburg Medical Center
PRS Account Philipps University Marburg Medical Center
Verification Date May 2012

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