Status: Closed
Activation Date: 2004NOV24
Closing Date: 2006MAY04
Phase: II
Description: A Phase II Study of SB-715992 (NSC 727990) in Patients With Locally Advanced, Recurrent or Metastatic Hepatocellular Carcinoma
Eligibility: Patients with histologically or cytologically documented hepatocellular carcinoma with locally advanced, recurrent or metastatic disease. Unidimensionally measurable disease by RECIST criteria. Prior intra-hepatic chemotherapy permitted; no prior systemic chemotherapy permitted. Patients must be > 4 weeks since major surgery, radiation therapy, local ablative therapy or intra-hepatic chemotherapy and must have hepatic reserve of Child-Turcotte-Pugh Class A or better. Patients with histological diagnosis must have archival tumour specimen available for correlative study.
Objective: To assess the efficacy (response rate and stable disease rate) of SB-715992 given by 1 hour intravenous infusion once every 3 weeks in patients with locally advanced, recurrent or metastatic hepatocellular carcinoma. To assess the toxicity of SB-715992 in patients with locally advanced, recurrent or metastatic hepatocellular carcinoma, as well as early progression rate, and, if responses are observed, response duration. To characterize the population pharmacokinetic (PK) parameters of SB-715992 including an assessment of significant covariates on SB-715992 PK and an assessment of the potential relationships between the pharmacokinetics of SB-715992 and relevant safety and efficacy endpoints. To describe the relationship between tumour expression of B-tubulin and KSP in archival paraffin fixed tumour tissue with clinical outcome of treatment with SB-715992. In a subset of separately consenting patients, to describe the changes in molecular markers of SB-715992 effect in PBMCs.
Participation: Limited to invited centres only.
Lay Description: The purpose of this study is to find out what effects an experimental drug, SB-715992, will have on primary liver cancer (hepatocellular carcinoma). In addition this study will evaluate the side effects of SB-715992, its blood levels, and in some patients who consent to special laboratory studies, the effect of the drug in white blood cells. As well, researchers will look at tumour tissue samples (samples from patients who have had liver cancer tissue previously removed) to learn about which types of primary liver cancer are most likely to be affected by SB-715992. Patients who meet all of the eligibility criteria will be given SB-715992 by needle into a vein once every 3 weeks.
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| Disease Site | Trial Code | Patients Accrued | Patients - Blocks | Patients - Slides | Patients - Blocks and/or Slides |
| IND | I168 | 15 | 3 | 1 | 3 |
(Core size is 0.6 mm)
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Fluid Samples| Disease Site | Trial Code | Patients Accrued | TMA Blocks | Patients on TMA Blocks |
| IND | I168 | 15 | 0 | 0 |
| Disease Site | Trial Code | Patients Accrued | Patients - Whole Blood | Patients - Cellular Component of Blood | Patients - DNA extracted from Blood | Patients - RNA extracted from Blood | Patients - Plasma | Patients - Serum | Patients - Urine | Patients - Buccal |
| IND | I168 | 15 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |