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Trial record 81 of 2728 for:    Neuroendocrine Tumors | Neuroendocrine Tumors

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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Neuroendocrine Tumors
Interventions Drug: Octreotide LAR (Long-acting release)
Drug: Placebo
Enrollment 85
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Octreotide LAR (SMS995) Placebo
Hide Arm/Group Description Octreotide LAR (Long-acting release) 30 mg intramuscularly every 28 days Sodium chloride intramuscularly every 28 days
Period Title: Overall Study
Started 42 43
Completed 33 40
Not Completed 9 3
Reason Not Completed
Withdrawal by Subject             4             2
Adverse Event             5             0
Switched to Octreotide             0             1
Arm/Group Title Octreotide LAR (SMS995) Placebo Total
Hide Arm/Group Description Octreotide LAR (Long-acting release) 30 mg intramuscularly every 28 days Sodium chloride intramuscularly every 28 days Total of all reporting groups
Overall Number of Baseline Participants 42 43 85
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 42 participants 43 participants 85 participants
63.5
(38 to 79)
61
(39 to 82)
62
(38 to 82)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants 43 participants 85 participants
Female
22
  52.4%
20
  46.5%
42
  49.4%
Male
20
  47.6%
23
  53.5%
43
  50.6%
1.Primary Outcome
Title Time to Tumor Progression Documented by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Conservative Intent to Treat (ITT) population consisting of all participants who received study drug. 3 participants in the Octreotide group and 1 participant in the placebo group without liver involvement at the beginning of the study were excluded from this analysis.
Arm/Group Title Octreotide LAR (SMS995) Placebo
Hide Arm/Group Description:
Octreotide LAR (Long-acting release) 30 mg intramuscularly every 28 days
Sodium chloride intramuscularly every 28 days
Overall Number of Participants Analyzed 39 42
Median (95% Confidence Interval)
Unit of Measure: Months
14.3
(11.0 to 28.8)
6.0
(3.7 to 9.4)
2.Secondary Outcome
Title Objective Response Rates According to World Health Organization (WHO) Criteria at 3 Month Intervals
Hide Description [Not Specified]
Time Frame at 3 month intervals
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Biochemical Response at 3 Month Intervals
Hide Description [Not Specified]
Time Frame at 3 month intervals up to 18 moths
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Symptom Control at 3 Month Intervals
Hide Description [Not Specified]
Time Frame at 3 month intervals up to 18 moths
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Quality of Life (Standardized Questionnaire) at Three-month Intervals in Comparison With the Start of the Study
Hide Description [Not Specified]
Time Frame at three-month intervals
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Survival
Hide Description [Not Specified]
Time Frame at least on a monthly basis
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Octreotide LAR (SMS995) Placebo
Hide Arm/Group Description Octreotide LAR (Long-acting release) 30 mg intramuscularly every 28 days Sodium chloride intramuscularly every 28 days
All-Cause Mortality
Octreotide LAR (SMS995) Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Octreotide LAR (SMS995) Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   11/42 (26.19%)   10/43 (23.26%) 
General disorders     
General Disorder   11/42 (26.19%)  10/43 (23.26%) 
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Octreotide LAR (SMS995) Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   19/42 (45.24%)   11/43 (25.58%) 
Blood and lymphatic system disorders     
Hematopoietic system  5/42 (11.90%)  1/43 (2.33%) 
Gastrointestinal disorders     
Gastrointestinal disorders   6/42 (14.29%)  8/43 (18.60%) 
General disorders     
General Health  8/42 (19.05%)  2/43 (4.65%) 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
Results Point of Contact
Name/Title: Carmen Schade-Brittinger
Organization: KKS Marburg
Phone: 0049-6421-2866458
Responsible Party: Carmen Schade-Brittinger, Philipps University Marburg Medical Center
ClinicalTrials.gov Identifier: NCT00171873     History of Changes
Obsolete Identifiers: NCT00202085
Other Study ID Numbers: CSMS995ADE05
First Submitted: September 13, 2005
First Posted: September 15, 2005
Results First Submitted: February 28, 2011
Results First Posted: March 28, 2011
Last Update Posted: May 10, 2012