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Spots Global Cancer Trial Database for SB-715992 in Treating Patients With Locally Advanced, Recurrent, or Metastatic Liver Cancer

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Trial Identification

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

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

Study ID: NCT00095992

Conditions

Liver Cancer

Interventions

ispinesib

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Jennifer Knox, MD

Affiliation: Princess Margaret Hospital, Canada

Role: STUDY_CHAIR

Name: Sharlene Gill, MD

Affiliation: British Columbia Cancer Agency

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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