Sorafenib Tosylate Before and After Hepatic Arterial Chemoembolization With Doxorubicin Hydrochloride and Mitomycin C in Treating Patients With Localized Liver Cancer That Cannot Be Removed by Surgery
- Conditions
- Liver Cancer
- Interventions
- Other: laboratory biomarker analysis
- Registration Number
- NCT00949182
- Lead Sponsor
- Rutgers, The State University of New Jersey
- Brief Summary
RATIONALE: Sorafenib tosylate 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. Drugs used in chemotherapy, such as doxorubicin hydrochloride and mitomycin C, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Chemoembolization kills tumor cells by carrying drugs directly into the tumor and blocking blood flow to the tumor. Giving sorafenib tosylate before and after chemoembolization may kill more tumor cells.
PURPOSE: This phase II trial is studying the side effects and how well giving sorafenib tosylate before and after hepatic arterial chemoembolization with doxorubicin hydrochloride and mitomycin C works in treating patients with localized liver cancer that cannot be removed by surgery.
- Detailed Description
OBJECTIVES:
Primary
* To evaluate the safety and tolerability of sorafenib tosylate therapy when administered before and after doxorubicin hydrochloride-based hepatic arterial chemoembolization (HACE) as assessed by NCI CTCAE v3.0 in patients with localized unresectable hepatocellular carcinoma.
Secondary
* To determine if sorafenib tosylate decreases the number of HACE treatments required to achieve radiologic tumor kill.
* To assess improvement in progression-free survival.
* To assess changes in monthly AFP levels in patients with AFP-producing tumors.
* To measure VEGF levels.
OUTLINE: Patients receive oral sorafenib tosylate twice daily on days 1-14. Beginning ≥ 3 days later, patients undergo hepatic arterial chemoembolization (HACE)\* with doxorubicin hydrochloride and mitomycin C. Beginning ≥ 3 days after the completion of HACE and/or once liver function returns to baseline, patients resume sorafenib tosylate twice daily for up to 6 months in the absence of disease progression or unacceptable toxicity.
NOTE: \*Patients may undergo more than one HACE treatment.
Blood samples are collected periodically for further laboratory analysis.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Sorafenib Tosylate, Doxorubicin, Mytomicin C laboratory biomarker analysis Micro and Macro arteriolar blockade of hepatocellular carcinoma (HCC): Treatment with Sorafenib 400mg two weeks prior to embolization HACE which includes the use of agents such as Doxorubicin Hydrochloride and Mytomicin C, continuing same Sorafenib dose after the procedure (dose adjustment according to tolerance).
- Primary Outcome Measures
Name Time Method Safety and tolerability as assessed by NCI CTCAE v3.0 06/2009 to 12/2010
- Secondary Outcome Measures
Name Time Method Number of hepatic arterial chemoembolization (HACE) treatments required to achieve objective complete response 06/2009 to 12/2010 Progression-free survival and time to radiologic progression as assessed by CT scan 06/2009 to 12/2010 Overall survival at 6, 12, and 24 months 06/2009 to 12/2011 AFP and VEGF serum levels as assessed at baseline, prior to each HACE treatment, and then every 3 months thereafter 06/2009 to 12/2011
Trial Locations
- Locations (1)
Rutgers University Hospital
🇺🇸Newark, New Jersey, United States