Sunitinib in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery
RATIONALE: Sunitinib 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.
PURPOSE: This phase II trial is studying how well sunitinib works 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:||Continuous Sunitinib Treatment in Patients With Unresectable Hepatocellular Carcinoma A Multicenter Phase II Trial|
- Progression-free survival [ Time Frame: at 12 weeks ] [ Designated as safety issue: No ]
- Objective response [ Time Frame: Objective response (CR+PR) to treatment will be determined. CR or PR is to be confirmed after a minimum of 4 weeks ] [ Designated as safety issue: No ]
- Disease stabilization (DS) [ Time Frame: Disease stabilization (CR, PR or SD) under sunitinib treatment will be determined ] [ Designated as safety issue: No ]
- Duration of DS [ Time Frame: Duration of DS (CR, PR or SD) will be calculated from the time that measurement criteria are met for the first time until documented tumor progression ] [ Designated as safety issue: No ]
- Progression-free survival [ Time Frame: PFS will be calculated from registration until documented tumor progression or death, whichever occurs first. ] [ Designated as safety issue: No ]
- Time to progression [ Time Frame: TTP will be calculated from registration until documented tumor progression or death due to tumor. ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: OS will be calculated from registration until death ] [ Designated as safety issue: No ]
- Adverse events as assessed by NCI CTCAE v3.0 [ Time Frame: All AEs will be assessed according to NCI CTCAE v3.0. ] [ Designated as safety issue: Yes ]
- Serum alpha fetoprotein level [ Time Frame: Serum AFP levels will be measured during the therapy, if AFP is ≥ 1.5 x ULN at baseline. ] [ Designated as safety issue: No ]
|Study Start Date:||July 2007|
|Study Completion Date:||February 2009|
|Primary Completion Date:||August 2008 (Final data collection date for primary outcome measure)|
|Experimental: Continuous sunitinib treatment||
Drug: sunitinib malate
Other Name: Sutent
- Demonstrate the antitumor activity of continuous sunitinib malate treatment in patients with unresectable hepatocellular carcinoma.
- Evaluate the safety of sunitinib malate treatment.
- Measure serum cobalamin (i.e., vitamin B12) level during sunitinib malate treatment in order to investigate the relationship between sunitinib malate treatment and cobalamin deficiency.
- Control the cobalamin deficiency by cobalamin replacement.
- Investigate whether changes in tumor density could be used as a criterion for tumor response in future trials.
OUTLINE: This is a multicenter study.
Patients receive oral sunitinib malate once daily. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients undergo blood sample collection on day 1 of each course to assess serum cobalamin levels and correlation with sunitinib malate treatment. Patients are also assessed for changes in tumor density and correlation with response. Baseline CT scans are compared with scans performed at 6 and 12 weeks to evaluate changes in CT-scan density due to tumor necrosis and response.
After completion of study therapy, patients are followed at least every 3 months for up to 3 years.