Sunitinib in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery
- Registration Number
- NCT00514228
- Lead Sponsor
- Swiss Group for Clinical Cancer Research
- Brief Summary
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.
- Detailed Description
OBJECTIVES:
Primary
* Demonstrate the antitumor activity of continuous sunitinib malate treatment in patients with unresectable hepatocellular carcinoma.
Secondary
* 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 45
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Continuous sunitinib treatment sunitinib malate -
- Primary Outcome Measures
Name Time Method Progression-free survival at 12 weeks
- Secondary Outcome Measures
Name Time Method Objective response Objective response (CR+PR) to treatment will be determined. CR or PR is to be confirmed after a minimum of 4 weeks Disease stabilization (DS) Disease stabilization (CR, PR or SD) under sunitinib treatment will be determined Duration of DS 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 Progression-free survival PFS will be calculated from registration until documented tumor progression or death, whichever occurs first. Time to progression TTP will be calculated from registration until documented tumor progression or death due to tumor. Overall survival OS will be calculated from registration until death Adverse events as assessed by NCI CTCAE v3.0 All AEs will be assessed according to NCI CTCAE v3.0. Serum alpha fetoprotein level Serum AFP levels will be measured during the therapy, if AFP is ≥ 1.5 x ULN at baseline.
Trial Locations
- Locations (1)
Kantonsspital - St. Gallen
🇨🇭St. Gallen, Switzerland