Advanced Adult Primary Liver Cancer Clinical Trial
Official title:
Phase II Trial of PS-341 in Patients With Hepatocellular Carcinoma
This phase II trial is studying how well bortezomib works in treating patients with hepatocellular carcinoma (liver cancer) that cannot be removed with surgery. Bortezomib may stop the growth of tumor cells by blocking the enzymes necessary for their growth.
PRIMARY OBJECTIVES:
I. Proportion of confirmed tumor responses.
SECONDARY OBJECTIVES:
I. To evaluate the confirmed and objective response rate. II. To assess patient outcome as
estimated by duration of response, time to disease progression, and survival.
III. To evaluate the adverse event rates associated with PS-341 in this population.
IV. To explore the relationships between laboratory correlates (eg. IHC) and patient outcome
(eg p53 and disease progression).
V. To evaluate alterations in laboratory correlates from pre-treatment measurements (ie, pre
and post treatment). The following immunohistochemistry (IHC) assays will be performed: IHC
of p53, IHC of p21, IHC of p27, IHC of NFkB, IHC of Ki67.
OUTLINE: This is a multicenter study.
Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat
every 21 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months until disease progression and then every 6 months for
up to 3 years from study entry.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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