Conditions: Liver Cancer
Keywords: adult primary hepatocellular carcinoma localized unresectable adult primary liver cancer advanced adult primary liver cancer
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 11
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: None

Interventions: intervention 1: Carboplatin intervention 2: Cisplatin intervention 3: Sorafenib
Intervention descriptions: intervention 1: Carboplatin AUC =6 at the investigator's discretion. Treatment is given every 6 weeks for up to 12 Cycles. intervention 2: Cisplatin 60 m/m² via percutaneous intrahepatic (IA) artery infusion at the investigator's discretion. Treatment is given every 6 weeks for up to 12 Cycles. intervention 3: Sorafenib 400 mg po bid daily starting on Day 1 (± up to 3 days) continuously.

Protocol document: