Liver Cancer Clinical Trial
Official title:
Continuous Sunitinib Treatment in Patients With Unresectable Hepatocellular Carcinoma A Multicenter Phase II Trial
RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes
needed for cell growth and by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying how well sunitinib works in treating patients with
liver cancer that cannot be removed by surgery.
OBJECTIVES:
Primary
- Demonstrate the antitumor activity of continuous sunitinib malate treatment in patients
with unresectable hepatocellular carcinoma.
Secondary
- Evaluate the safety of sunitinib malate treatment.
- Measure serum cobalamin (i.e., vitamin B12) level during sunitinib malate treatment in
order to investigate the relationship between sunitinib malate treatment and cobalamin
deficiency.
- Control the cobalamin deficiency by cobalamin replacement.
- Investigate whether changes in tumor density could be used as a criterion for tumor
response in future trials.
OUTLINE: This is a multicenter study.
Patients receive oral sunitinib malate once daily. Treatment continues in the absence of
disease progression or unacceptable toxicity.
Patients undergo blood sample collection on day 1 of each course to assess serum cobalamin
levels and correlation with sunitinib malate treatment. Patients are also assessed for
changes in tumor density and correlation with response. Baseline CT scans are compared with
scans performed at 6 and 12 weeks to evaluate changes in CT-scan density due to tumor
necrosis and response.
After completion of study therapy, patients are followed at least every 3 months for up to 3
years.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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