Cisplatin or Carboplatin and Sorafenib in Treating Patients With Liver Cancer That Cannot Be Removed By Surgery
- Registration Number
- NCT00875615
- Lead Sponsor
- University of Miami
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 11
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Cisplatin or Carboplatin + Sorafenib Sorafenib - Cisplatin or Carboplatin + Sorafenib Carboplatin - Cisplatin or Carboplatin + Sorafenib Cisplatin -
- Primary Outcome Measures
Name Time Method Number of Subjects Experiencing Adverse Events 36 months The number of subjects experiencing adverse events after receiving protocol therapy.
- Secondary Outcome Measures
Name Time Method Number of Patients Achieving Clinical Benefit 36 months Number of patients achieving complete or partial response according to RECIST criteria
Trial Locations
- Locations (1)
University of Miami Sylvester Comprehensive Cancer Center - Miami
🇺🇸Miami, Florida, United States