Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00023855
Status:
COMPLETED
Last Update Posted:
2019-12-13
First Post:
2001-09-13
Brief Title:
PS-341 and Doxorubicin in Treating Patients With Advanced Solid Tumors
Sponsor:
University of Wisconsin Madison
Organization:
University of Wisconsin Madison
Study Overview
Official Title:
A Phase I and Pharmacodynamic Study of Proteasome Inhibitor PS-341 in Combination With Doxorubicin in Patients With Advanced Solid Tumors
Status:
COMPLETED
Status Verified Date:
2015-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-3771 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA014520 |
| P30CA014520 | NIH | None | None |
| WCCC-CO-01901 | None | None | None |