Aloxi for Prevention of Chemotherapy Induced Nausea and Vomiting in Malignant Glioma Patients Receiving Irinotecan With Bevacizumab

This study has been terminated.
(Study was halted early after 63 subjects were enrolled due to slow accrual.)
Sponsor:
Collaborators:
Eisai Inc.
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00636805
First received: February 27, 2008
Last updated: March 4, 2014
Last verified: March 2014
Results First Received: January 9, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Supportive Care
Condition: Brain Cancer
Intervention: Drug: Palonosetron (Aloxi) and Dexamethasone

  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
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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
Patient Receives IV Aloxi

Patient receives IV Aloxi

Palonosetron (Aloxi) and Dexamethasone: single i.v. , dose of palonosetron 0.25 mg, and 10mg dexamethasone infused over 15 min, administered 30 min before the first dose Irinotecan and Bevacizumab chemotherapy.


Participant Flow:   Overall Study
    Patient Receives IV Aloxi  
STARTED     63  
COMPLETED     63  
NOT COMPLETED     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.
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Reporting Groups
  Description
Patient Receives IV Aloxi

Patient receives IV Aloxi

Palonosetron (Aloxi) and Dexamethasone: single i.v. , dose of palonosetron 0.25 mg, and 10mg dexamethasone infused over 15 min, administered 30 min before the first dose Irinotecan and Bevacizumab chemotherapy.


Baseline Measures
    Patient Receives IV Aloxi  
Number of Participants  
[units: participants]
  63  
Age  
[units: years]
Mean ± Standard Deviation
  53.2  ± 13.1  
Gender  
[units: participants]
 
Female     21  
Male     42  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Acute CINV (Chemotherapy Induced Nausea and Vomiting) CR (Complete Response) Rate   [ Time Frame: first 24 hours of the first week of chemotherapy ]

2.  Secondary:   Acute Chemotherapy-Induced Nausea and Vomiting (CINV) Complete Response (CR) Rate by Corticosteroid Use at Baseline   [ Time Frame: Day 1 of the first week of chemotherapy ]

3.  Secondary:   Acute Chemotherapy-Induced Nausea and Vomiting (CINV) Complete Response (CR) Rate by Anticoagulant Use at Baseline   [ Time Frame: Day 1 of the first week of chemotherapy ]

4.  Secondary:   Delayed Chemotherapy-Induced Nausea and Vomiting (CINV) Complete Response (CR) Rate   [ Time Frame: Days 2-5 of the first week of chemotherapy ]

5.  Secondary:   Percentage of Patients With ≥ Grade 3, Treatment-related Toxicities   [ Time Frame: 6 weeks ]

6.  Secondary:   Overall Mean Change in the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score From Baseline to Day 5 of the First Week of Chemotherapy   [ Time Frame: Baseline through day 5 of the first week of chemotherapy ]

7.  Secondary:   Overall Mean Change in the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score From Baseline to Day 5 of the First Week of Chemotherapy by Acute Chemotherapy-Induced Nausea and Vomiting (CINV) Complete Response (CR)   [ Time Frame: Baseline through day 5 of the first week of chemotherapy ]


  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:  
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 agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Mary Lou Affronti
Organization: Duke University Medical Center
phone: 919-6846239
e-mail: mary.affronti@dm.duke.edu


No publications provided


Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00636805     History of Changes
Other Study ID Numbers: Pro00002273, P50NS020023
Study First Received: February 27, 2008
Results First Received: January 9, 2014
Last Updated: March 4, 2014
Health Authority: United States: Institutional Review Board