Clinical Trials Directory

Trials / Completed

CompletedNCT00054483

Bortezomib in Treating Patients With Advanced Cancer and Kidney Dysfunction

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

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
69 (actual)
Sponsor
National Cancer Institute (NCI) · NIH
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
DRUGbortezomibGiven IV
OTHERlaboratory biomarker analysisCorrelative studies
OTHERpharmacological studyCorrelative studies

Timeline

Start date
2003-01-01
Primary completion
2009-09-01
First posted
2003-02-06
Last updated
2013-05-16

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00054483. Inclusion in this directory is not an endorsement.