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Doxorubicin and Bortezomib in Treating Patients With Liver Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00083226
First received: May 14, 2004
Last updated: October 24, 2014
Last verified: January 2014
Results First Received: October 24, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Adult Primary Hepatocellular Carcinoma
Advanced Adult Primary Liver Cancer
Localized Unresectable Adult Primary Liver Cancer
Recurrent Adult Primary Liver Cancer
Interventions: Drug: doxorubicin
Drug: bortezomib

  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
This study was activated on March 19, 2004 and terminated on February 12,2007 after meeting its accrual goal of 40 patients. The final accrual of the study was 42 patients, enrolled through 4 ECOG member institutions.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Treatment (Doxorubicin+Bortezomib)

Patients receive doxorubicin IV over 5-15 minutes on days 1 and 8. Patients also receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients with no disease progression may continue to receive bortezomib alone in the absence of disease progression or unacceptable toxicity.

doxorubicin: Given IV

bortezomib: Given IV


Participant Flow:   Overall Study
    Treatment (Doxorubicin+Bortezomib)  
STARTED     42  
COMPLETED     0  
NOT COMPLETED     42  
Lack of Efficacy                 19  
Adverse Event                 9  
Death                 4  
Withdrawal by Subject                 4  
unknown                 2  
ineligible or not receiving treatment                 4  



  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.
The primary population was the 38 eligible and treated patients

Reporting Groups
  Description
Treatment (Doxorubicin+Bortezomib)

Patients receive doxorubicin IV over 5-15 minutes on days 1 and 8. Patients also receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients with no disease progression may continue to receive bortezomib alone in the absence of disease progression or unacceptable toxicity.

doxorubicin: Given IV

bortezomib: Given IV


Baseline Measures
    Treatment (Doxorubicin+Bortezomib)  
Number of Participants  
[units: participants]
  38  
Age  
[units: years]
Mean ± Standard Deviation
  57.1  ± 11.1  
Gender  
[units: participants]
 
Female     11  
Male     27  
Region of Enrollment  
[units: participants]
 
United States     38  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Objective Response Rate Measured by Response Evaluation Criteria In Solid Tumors (RECIST)   [ Time Frame: assessed every 3 cycles while on treatment. After discontinuing treatment, assessed every 3 months for 2 years and then every 6 months for 1 year ]

2.  Secondary:   Overall Survival   [ Time Frame: assessed every 3 months for 2 years and then every 6 months for 1 year ]

3.  Secondary:   Progression Free Survival   [ Time Frame: assessed every 3 cycles while on treatment. After discontinuing treatment, assessed every 3 months for 2 years and then every 6 months for 1 year. ]


  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
No text entered.


  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 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Study Statistician
Organization: ECOG Statistical Office
phone: 617-632-3012


No publications provided


Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00083226     History of Changes
Other Study ID Numbers: NCI-2014-00654, NCI-2012-02952, E6202, U10CA021115
Study First Received: May 14, 2004
Results First Received: October 24, 2014
Last Updated: October 24, 2014
Health Authority: United States: Food and Drug Administration