Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial
Official title:
A Phase I Pharmacokinetic Study of PS341 in Patients With Advanced Malignancies and Varying Degrees of Renal Dysfunction for the CTEP-Sponsored Organ Dysfunction Working Group
Phase I trial to study the effectiveness of bortezomib in treating patients who have advanced cancer and kidney dysfunction. Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth.
PRIMARY OBJECTIVES:
I. To identify the pharmacokinetic and pharmacodynamic profile of PS-341 in patients with
advanced malignancy and mild, moderate or severe renal insufficiency.
II. Evaluate the safety, tolerability, and the maximum tolerated dose of PS-341 for patients
with varying degrees of renal insufficiency.
OUTLINE: This is a dose-escalation, multicenter study. Patients are stratified according to
most recent creatinine clearance (greater than 60 mL/min vs 40-59 mL/min vs 20-39 mL/min vs
less than 20 mL/min vs any creatinine clearance and undergoing renal dialysis).
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.
Cohorts of 3-6 patients receive escalating doses of bortezomib until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2
of 6 patients experience dose-limiting toxicity. Once the MTD is determined, an additional
cohort of up to 12 patients is treated at the MTD.
PROJECTED ACCRUAL: A total of 60-69 patients (at least 12 per stratum) will be accrued for
this study.
;
Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
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