NCT00514228

Sunitinib in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery

Continuous Sunitinib Treatment in Patients With Unresectable Hepatocellular Carcinoma A Multicenter Phase II Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Swiss Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Liver Cancer

Interventions

Type	Name	Description
DRUG	sunitinib malate	* Starting dose: 37.5 mg 3 x 12.5 mg capsule * Reduced dose: 25 mg 2 x 12.5 mg capsule

Timeline

• Start date: 2007-07-01
• Primary completion: 2008-08-01
• Completion: 2009-02-01
• First posted: 2007-08-09
• Last updated: 2012-06-26

Locations

1 site across 1 country: Switzerland