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SB-715992 in Treating Patients With Locally Advanced, Recurrent, or Metastatic Liver Cancer

Liver Cancer Clinical Trial

Official title:
A Phase II Study Of SB-715992 (NSC 727990) In Patients With Locally Advanced, Recurrent Or Metastatic Hepatocellular Carcinoma

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00095992
Study type Interventional
Source Canadian Cancer Trials Group
Contact
Status Completed
Phase Phase 2
Start date March 8, 2005
Completion date September 22, 2008
View Details
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