SU011248 in Advanced Hepatocellular Carcinoma

• Status: Completed
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The main purpose of this study is to begin to collect information and try to learn whether SU011248 works in treating patients with advanced liver cancer. Laboratory studies have shown that SU011248 may block the growth of blood vessels in tumors, which may prevent tumors from growing any further.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Collaborators: Beth Israel Deaconess Medical Center; Brigham and Women's Hospital; Dana-Farber Cancer Institute
• Treatments: Sunitinib

Criteria

Inclusion Criteria:

• Histologically or cytologically confirmed HCC and should have metastatic or locally advanced unresectable disease

• Measurable disease

• 0-1 prior systemic chemotherapy regimens for HCC

• Age 18 years or older

• Life expectancy of greater than 12 weeks

• ECOG performance status of 0-1

• Adequate organ and marrow function

• Women of child-bearing potential must have a negative pregnancy test prior to study entry

Exclusion Criteria:

• Chemotherapy, radiotherapy or major surgery within 4 weeks of study entry

• Receiving any other investigational agents within past 30 days

• Known brain metastases

• CLIP score > 3

• Chronic diarrhea or any disorder that will limit adequate absorption of SU011248

• Prolongation of QTc > 450 msec in screening electrocardiogram or history of familial long QT syndrome

• Uncontrolled intercurrent illness

• Pregnant or lactating women

• Greater than or equal to 2g of protein/24hr