Cisplatin or Carboplatin and Sorafenib in Treating Patients With Liver Cancer That Cannot Be Removed By Surgery
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of Intrahepatic Artery Chemotherapy With Nexavar in Hepatocellular Carcinoma Patients|
- Number of Subjects Experiencing Adverse Events [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]The number of subjects experiencing adverse events after receiving protocol therapy.
- Number of Patients Achieving Clinical Benefit [ Time Frame: 36 months ] [ Designated as safety issue: No ]Number of patients achieving complete or partial response according to RECIST criteria
|Study Start Date:||December 2008|
|Study Completion Date:||June 2012|
|Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
|Experimental: Cisplatin or Carboplatin + Sorafenib||
Carboplatin AUC =6 at the investigator's discretion. Treatment is given every 6 weeks for up to 12 Cycles.Drug: Cisplatin
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.Drug: Sorafenib
Sorafenib 400 mg po bid daily starting on Day 1 (± up to 3 days) continuously.
- To assess the safety of intrahepatic arterial infusion of cisplatin or carboplatin in combination with sorafenib tosylate in patients with unresectable hepatocellular carcinoma.
- 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.
|United States, Florida|
|University of Miami Sylvester Comprehensive Cancer Center - Miami|
|Miami, Florida, United States, 33136|
|Principal Investigator:||Lynn G. Feun, MD||University of Miami Sylvester Comprehensive Cancer Center|