RATIONALE: Drugs used in chemotherapy, such as SB-715992, work in different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: This phase II trial is studying how well SB-715992 works in treating patients with locally advanced, recurrent, or metastatic liver cancer.
OBJECTIVES: * Determine the efficacy of SB-715992, in terms of response rate and stable disease rate, in patients with locally advanced, recurrent, or metastatic hepatocellular carcinoma. * Determine the toxicity of this drug in these patients. * Determine the early progression rate and response duration in patients treated with this drug. * Determine the pharmacokinetics of this drug in these patients. * Correlate pharmacokinetics with safety and efficacy of this drug in these patients. * Correlate tumor expression of β-tubulin and kinesin spindle protein with clinical outcomes in patients treated with this drug. OUTLINE: This is a non-randomized, multicenter study. Patients receive SB-715992 IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. All patients are followed at 4 weeks. Patients with ongoing stable or responding disease are followed every 3 months until relapse. PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study within 12-14 months.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
15
SB-715992 will be given as a 1 hour intravenous infusion in a dose of 18 mg/m2 once every 3 weeks
BCCA - Vancouver Cancer Centre
Vancouver, British Columbia, Canada
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Ontario, Canada
Cancer Centre of Southeastern Ontario at Kingston
Kingston, Ontario, Canada
Univ. Health Network-Princess Margaret Hospital
Toronto, Ontario, Canada
Response
Time frame: 4 years
Toxicity
Time frame: 4 years
Pharmacokinetics at day 1 of course 1 (day 1 of course 2 if dose is adjusted)
Time frame: 4 years
Molecular correlates on archival tumor specimens and peripheral blood mononuclear cells (PBMCs)
Time frame: 4 years
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