Conditions: Liver Cancer
Keywords: Hepatocellular cancer (HCC) Sunitinib malate Vascular endothelial growth factor (VEGF) Platelet-derived growth factor (PDGF) Tyrosine kinases Liver
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 33
Healthy volunteers: no

Brief summary:
An open label multi-site phase II clinical trial of dose escalated sunitinib malate given orally once daily on days 1-28 of each 42-day cycle. Treatment will be continued until there is either disease progression or cumulative or acute toxicity which in the opinion of the treating physician compromises the ability of the patient to receive treatment or patient desire to stop treatment.

Detailed description:
An open label multi-site phase II clinical trial of sunitinib malate given orally once daily on days 1-28 of each 42-day cycle. Sunitinib malate will be dispensed as capsules at the beginning of each treatment cycle. The dose may be escalated at the investigator's discretion. Treatment will be continued until there is either disease progression or cumulative or acute toxicity which in the opinion of the treating physician compromises the ability of the patient to receive treatment or patient desire to stop treatment.

A follow up visit will be required before the beginning of every cycle every 6 weeks to assess toxicity and for physical examination. Complete blood count (CBC) and differential, comprehensive metabolic panel (including liver function tests) and alpha-feto protein (when indicated) will be obtained at every scheduled follow up visit.

Arms:
arm 1: None

Interventions: intervention 1: Sunitinib Malate
Intervention descriptions: intervention 1: Once daily oral doses on days 1-28 of each 42-day cycle. The dose for the first 2 cycles will be 37.5 mg daily for 28 days, every 42 days. Dose may be escalated to 50 mg daily for 28 days at the treating investigator's discretion.

Protocol document: