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

This study has been terminated.
(low accrual)
Sponsor:
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT00524316
First received: August 31, 2007
Last updated: May 19, 2014
Last verified: May 2014
Results First Received: December 26, 2013  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: 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  
Number of Participants  
[units: participants]
  16  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     7  
>=65 years     9  
Age  
[units: years]
Mean ± Standard Deviation
  63.8  ± 13.9  
Gender  
[units: participants]
 
Female     4  
Male     12  



  Outcome Measures
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1.  Primary:   Progression-free Survival at 4 Months   [ Time Frame: 4 months ]

2.  Secondary:   Overall Survival   [ Time Frame: Every 6 months after removal from treatment till death ]

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 ]

5.  Secondary:   Quality of Life as Measured by the FACT-HEP Scale Prior to Each Course of Therapy   [ Time Frame: Every 6 weeks ]

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


No publications provided


Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT00524316     History of Changes
Other Study ID Numbers: CDR0000563261, RPCI-I-82706
Study First Received: August 31, 2007
Results First Received: December 26, 2013
Last Updated: May 19, 2014
Health Authority: United States: Food and Drug Administration