Liver Cancer Clinical Trial
Official title:
Phase II Trial of Intrahepatic Artery Chemotherapy With Nexavar in Hepatocellular Carcinoma Patients
RATIONALE: Drugs used in chemotherapy, such as cisplatin and carboplatin, work in different
ways to stop the growth of tumor cells, either by killing the cells or by stopping them from
dividing. Sorafenib 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. Infusing chemotherapy
directly into the liver and giving it together with sorafenib may kill more tumor cells.
PURPOSE: This phase II trial is studying the side effects of infusing cisplatin or
carboplatin directly into the liver and giving it together with sorafenib in treating
patients with liver cancer that cannot be removed by surgery.
OBJECTIVES:
Primary
- To assess the safety of intrahepatic arterial infusion of cisplatin or carboplatin in
combination with sorafenib tosylate in patients with unresectable hepatocellular
carcinoma.
Secondary
- To assess the time to tumor progression in patients treated with this regimen.
- To assess the overall and progression-free survival of patients treated with this
regimen.
OUTLINE: Patients receive intrahepatic arterial infusion of cisplatin or carboplatin over
30-45 minutes on day 1 and oral sorafenib tosylate twice daily on days 8-35. Treatment
repeats every 42 days for up to 12 courses in the absence of disease progression or
unacceptable toxicity.
After completion of study treatment, patients are followed periodically.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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