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Sunitinib and Chemoembolization in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery

This study has been terminated.
(low accrual)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00524316
First Posted: September 3, 2007
Last Update Posted: May 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Roswell Park Cancer Institute
Results First Submitted: December 26, 2013  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Liver Cancer
Interventions: Drug: doxorubicin hydrochloride
Drug: sunitinib malate
Other: laboratory biomarker analysis
Procedure: hepatic artery embolization
Procedure: quality-of-life assessment

  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
No text entered.

Reporting Groups
  Description
Treatment: Sunitinib and Chemoembolization Treatment: Cycle (C)1-Sunitinib 37.5mg po d1-7 followed by TACE with doxorubicin in lipodiol on d8, continued sunitinib 37.5mg po qd d15-36 followed by 2 weeks off. C2 onwards- sunitinib 4 weeks on and 2 weeks off, with dose escalation to 50 mg in pts without any grade 3 toxicities in C1.

Participant Flow:   Overall Study
    Treatment: Sunitinib and Chemoembolization
STARTED   16 
COMPLETED   0 
NOT COMPLETED   16 
Withdrawal by Subject                2 
Adverse Event                7 
Disease Progression                7 



  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
Treatment: Sunitinib and Chemoembolization Treatment: Cycle (C)1-Sunitinib 37.5mg po d1-7 followed by TACE with doxorubicin in lipodiol on d8, continued sunitinib 37.5mg po qd d15-36 followed by 2 weeks off. C2 onwards- sunitinib 4 weeks on and 2 weeks off, with dose escalation to 50 mg in pts without any grade 3 toxicities in C1.

Baseline Measures
   Treatment: Sunitinib and Chemoembolization 
Overall Participants Analyzed 
[Units: Participants]
 16 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      7  43.8% 
>=65 years      9  56.3% 
Age 
[Units: Years]
Mean (Standard Deviation)
 63.8  (13.9) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      4  25.0% 
Male      12  75.0% 


  Outcome Measures
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1.  Primary:   Progression-free Survival   [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months ]

2.  Secondary:   Overall Survival   [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months ]

3.  Secondary:   Tissue Perfusion, Ktrans, IAUC, and Percent Viable Tumor as Measured by DCE-MRI at Baseline and on Days 8 (Before Transarterial Chemoembolization), 10, and 35   [ Time Frame: Baseline, day 8, day 10, day 28 and day 35 ]

4.  Secondary:   Safety and Tolerability   [ Time Frame: Daily while on treatment through study completion, an average of 1 year ]

5.  Secondary:   Assess the Change in the Quality of Life Among Patients Using the FACTHep (Version 4) for Hepatobiliary Cancers.   [ Time Frame: Baseline and Cycle 2 ]

6.  Secondary:   Tumor Marker Response (AFP)   [ Time Frame: Baseline, week 7 and every 6 weeks after ]


  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
Due to the study’s early termination and inadequate number of patients, no patients were analyzed.


  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: Senior Administrator, Compliance - Clinical Research Services
Organization: Roswell Park Cancer Institute
phone: 716-845-2300



Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT00524316     History of Changes
Other Study ID Numbers: CDR0000563261
RPCI-I-82706
First Submitted: August 31, 2007
First Posted: September 3, 2007
Results First Submitted: December 26, 2013
Results First Posted: June 4, 2014
Last Update Posted: May 9, 2017