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Sorafenib Tosylate With or Without Doxorubicin Hydrochloride in Treating Patients With Locally Advanced or Metastatic Liver Cancer

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ClinicalTrials.gov Identifier: NCT01015833
Recruitment Status : Active, not recruiting
First Posted : November 18, 2009
Results First Posted : May 2, 2018
Last Update Posted : May 2, 2018
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Treatment
Conditions: Advanced Adult Hepatocellular Carcinoma
Non-Resectable Hepatocellular Carcinoma
Recurrent Hepatocellular Carcinoma
Stage III Hepatocellular Carcinoma AJCC v7
Stage IIIA Hepatocellular Carcinoma AJCC v7
Stage IIIB Hepatocellular Carcinoma AJCC v7
Stage IIIC Hepatocellular Carcinoma AJCC v7
Stage IV Hepatocellular Carcinoma AJCC v7
Stage IVA Hepatocellular Carcinoma AJCC v7
Stage IVB Hepatocellular Carcinoma AJCC v7
Interventions: Drug: Doxorubicin Hydrochloride
Other: Laboratory Biomarker Analysis
Other: Pharmacogenomic Study
Drug: Sorafenib Tosylate

  Participant Flow

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
No text entered.

Reporting Groups
  Description
Arm I (Doxorubicin Hydrochloride, Sorafenib Tosylate) Patients receive 60 mg/m2 doxorubicin hydrochloride IV on day 1 and 400 mg sorafenib tosylate PO QD or BID on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. After 6 courses, patients may continue to receive sorafenib tosylate PO QD or BID in the absence of disease progression or unacceptable toxicity.
Arm II (Sorafenib Tosylate) Patients receive 400 mg sorafenib tosylate PO QD or BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Participant Flow:   Overall Study
    Arm I (Doxorubicin Hydrochloride, Sorafenib Tosylate)   Arm II (Sorafenib Tosylate)
STARTED   180   176 
COMPLETED   167   171 
NOT COMPLETED   13   5 
Death                1                0 
Withdrawal by Subject                3                2 
Adverse Event                0                1 
Physician Decision                2                0 
Symptomatic deterioration                0                1 
Other                5                1 
Motor Vehicle Accidents                1                0 
Did not start treatment                1                0 



  Baseline Characteristics

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 (Doxorubicin Hydrochloride, Sorafenib Tosylate) Patients receive 60 mg/m2 doxorubicin hydrochloride IV on day 1 and 400 mg sorafenib tosylate PO QD or BID on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. After 6 courses, patients may continue to receive sorafenib tosylate PO QD or BID in the absence of disease progression or unacceptable toxicity.
Arm II (Sorafenib Tosylate) Patients receive 400 mg sorafenib tosylate PO QD or BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Total Total of all reporting groups

Baseline Measures
   Arm I (Doxorubicin Hydrochloride, Sorafenib Tosylate)   Arm II (Sorafenib Tosylate)   Total 
Overall Participants Analyzed 
[Units: Participants]
 180   176   356 
Age 
[Units: Years]
Median (Full Range)
 62 
 (22 to 81) 
 62 
 (31 to 85) 
 62 
 (22 to 85) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      27  15.0%      23  13.1%      50  14.0% 
Male      153  85.0%      153  86.9%      306  86.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
Canada   32   29   61 
United States   148   147   295 


  Outcome Measures

1.  Primary:   Overall Survival   [ Time Frame: Up to 3 years ]

2.  Secondary:   Incidence of Toxicities, as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0   [ Time Frame: Up to 3 years ]

3.  Secondary:   Progression Free Survival   [ Time Frame: Up to 3 years ]

4.  Secondary:   Time to Progression (TTP)   [ Time Frame: Up to 3 years ]

5.  Secondary:   Best Overall Response Rate   [ Time Frame: Up to 3 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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

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: Ghassan Abou-Alfa, MD
Organization: Memorial Sloan-Kettering Cancer Center
phone: 646-888-4184
e-mail: abou-alg@mskcc.org



Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01015833     History of Changes
Other Study ID Numbers: NCI-2011-01989
NCI-2011-01989 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000659348
CALGB-80802 ( Other Identifier: Alliance for Clinical Trials in Oncology )
CALGB-80802 ( Other Identifier: CTEP )
U10CA180821 ( U.S. NIH Grant/Contract )
U10CA031946 ( U.S. NIH Grant/Contract )
First Submitted: November 17, 2009
First Posted: November 18, 2009
Results First Submitted: December 1, 2017
Results First Posted: May 2, 2018
Last Update Posted: May 2, 2018