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Octreotide in Treating Patients With Cancer-Related Malignant Ascites

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00182754
First received: September 15, 2005
Last updated: February 28, 2017
Last verified: February 2017
Results First Received: February 28, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Participant, Investigator;   Primary Purpose: Treatment
Conditions: Metastatic Cancer
Unspecified Adult Solid Tumor, Protocol Specific
Interventions: Drug: octreotide acetate
Other: placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Arm I Patients receive 30 mg octreotide subcutaneously (SC) intramuscularly once on day 1. octreotide acetate: Given subcutaneously
Arm II Patients receive 2 milliliters placebo (0.9% sodium chloride) SC once on day 1. placebo: Given subcutaneously

Participant Flow:   Overall Study
    Arm I   Arm II
STARTED   16   17 
COMPLETED   16   17 
NOT COMPLETED   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Arm I Patients receive 30 mg octreotide subcutaneously (SC) intramuscularly once on day 1. octreotide acetate: Given subcutaneously
Arm II Patients receive 2 milliliters placebo (0.9% sodium chloride) SC once on day 1. placebo: Given subcutaneously
Total Total of all reporting groups

Baseline Measures
   Arm I   Arm II   Total 
Overall Participants Analyzed 
[Units: Participants]
 16   17   33 
Age 
[Units: Years]
Median (Full Range)
 62 
 (45 to 90) 
 69 
 (40 to 88) 
 63 
 (40 to 90) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      10  62.5%      12  70.6%      22  66.7% 
Male      6  37.5%      5  29.4%      11  33.3% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      1   6.3%      0   0.0%      1   3.0% 
Not Hispanic or Latino      14  87.5%      17 100.0%      31  93.9% 
Unknown or Not Reported      1   6.3%      0   0.0%      1   3.0% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Median Time to Paracentesis   [ Time Frame: Up to 2 years ]

2.  Secondary:   Number of Paracenteses   [ Time Frame: Up to 2 years ]

3.  Secondary:   Average Quality-of-life   [ Time Frame: Up to 2 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Aminah Jatoi, M.D
Organization: Mayo Clinic
phone: 507-284-4918
e-mail: jatoi.aminah@mayo.edu



Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00182754     History of Changes
Other Study ID Numbers: NCCTG-N04C2
NCI-2009-00647 ( Registry Identifier: CTRP (Clinical Trials Reporting System) )
CDR0000440922 ( Registry Identifier: PDQ (Physician Data Query) )
Study First Received: September 15, 2005
Results First Received: February 28, 2017
Last Updated: February 28, 2017