SB-715992 in Treating Patients With Locally Advanced, Recurrent, or Metastatic Liver Cancer
- Conditions
- Liver Cancer
- Registration Number
- NCT00095992
- Lead Sponsor
- NCIC Clinical Trials Group
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Response 4 years
- Secondary Outcome Measures
Name Time Method Molecular correlates on archival tumor specimens and peripheral blood mononuclear cells (PBMCs) 4 years Toxicity 4 years Pharmacokinetics at day 1 of course 1 (day 1 of course 2 if dose is adjusted) 4 years
Trial Locations
- Locations (4)
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
BCCA - Vancouver Cancer Centre
🇨🇦Vancouver, British Columbia, Canada