Clinical Trial: Bortezomib in Treating Patients With Advanced Cancer and Kidney Dysfunction
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
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
Brief 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 Summary:
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.
Sponsor: National Cancer Institute (NCI)
Current Primary Outcome:
- Pharmacokinetics in terms of 20S proteasome activity following bortezomib administration [ Time Frame: Days 1 and 8 pre-infusion (of course 1) and 5, 15, 30, and 60 minutes, and 2, 4, 6, 8, 12, and 24 hours post-bortezomib administration ]
- Dose-limiting toxicities of bortezomib graded according to the National Cancer Institute Common Toxicity Criteria (NCI CTC) v2.0 [ Time Frame: Up to 21 days ]
Original Primary Outcome:
Current Secondary Outcome:
Original Secondary Outcome:
Information By: National Cancer Institute (NCI)
Dates:
Date Received: February 5, 2003
Date Started: January 2003
Date Completion:
Last Updated: May 15, 2013
Last Verified: May 2013
