Clinical Trials Directory

Trials / Completed

CompletedNCT00006362

PS-341 in Treating Patients With Advanced Cancer

A Phase I and Pharmacologic Study of the Proteasome Inhibitor PS-341 in Patients With Advanced Solid Tumors and B-cell Lymphoproliferative Disorders

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
—
Sponsor
Mayo Clinic · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of PS-341 in treating patients who have advanced cancer.

Detailed description

OBJECTIVES: * Determine the maximum tolerated dose and toxicity of PS-341 in patients with advanced malignancies. * Determine, in a preliminary manner, the therapeutic activity of this regimen in these patients. OUTLINE: This is a dose-escalation, multicenter study. * Regimen A: Patients receive PS-341 IV twice weekly for 4 weeks. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of PS-341 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 1 of 3-4 or 2 of 6 patients experience dose-limiting toxicity. * Regimen B: Once the MTD has been determined in regimen A, patients receive PS-341 IV twice weekly for 2 weeks. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed for 3 months. PROJECTED ACCRUAL: A maximum of 78 patients will be accrued for this study within 14 months.

Conditions

Interventions

TypeNameDescription
DRUGbortezomib

Timeline

Start date
1999-11-01
Primary completion
2003-08-01
Completion
2003-08-01
First posted
2003-01-27
Last updated
2011-08-03

Locations

2 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT00006362. Inclusion in this directory is not an endorsement.