PS-341 and Doxorubicin in Treating Patients With Advanced Solid Tumors
- Conditions
- Unspecified Adult Solid Tumor, Protocol Specific
- Registration Number
- NCT00023855
- Lead Sponsor
- University of Wisconsin, Madison
- Brief 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 combining PS-341 and doxorubicin in treating patients who have advanced solid tumors.
- Detailed Description
OBJECTIVES:
* 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 patients.
* 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Wisconsin Comprehensive Cancer Center
🇺🇸Madison, Wisconsin, United States
University of Wisconsin Comprehensive Cancer Center🇺🇸Madison, Wisconsin, United States