A Phase I and Pharmacodynamic Study of Proteasome Inhibitor, PS-341, in Combination With Doxorubicin in Patients With Advanced Solid Tumors
- Determine the maximum tolerated dose of PS-341 in combination with doxorubicin in
patients with advanced solid tumors.
- Determine the qualitative and quantitative toxic effects of this regimen in these
- Determine the antitumor activity of this regimen in these patients.
OUTLINE: This is a dose-escalation study of PS-341.
Patients receive PS-341 IV over 3-5 seconds on days 1, 4, 8, and 11; and doxorubicin IV on
over 3-5 minutes on days 1 and 8. Treatment repeats every 21 days 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 at least 2 of 3
or 2 of 6 patients experience dose-limiting toxicity.
PROJECTED ACCRUAL: A total of 3-31 patients will be accrued for this study within 1 year.
Primary Purpose: Treatment
James P. Thomas, MD, PhD
Ohio State University Comprehensive Cancer Center
United States: Federal Government
|University of Wisconsin Comprehensive Cancer Center||Madison, Wisconsin 53792|