Ignite Creation Date:
2024-05-05 @ 11:27 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00049400
Status:
COMPLETED
Last Update Posted:
2015-04-03
First Post:
2002-11-12
Brief Title:
S0355 Ixabepilone in Treating Patients With Advanced Solid Tumors or Lymphomas and Liver Dysfunction
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
A Phase I Pharmacokinetic Study Of Epothilone B Analogue BMS-247550 NSC 710428D In Patients With Advanced Malignancies And Varying Levels Of Liver Dysfunction
Status:
COMPLETED
Status Verified Date:
2015-04
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 work in different ways to stop tumor cells from dividing so they stop growing or die
PURPOSE This phase I trial is studying the side effects and best dose of ixabepilone in treating patients with advanced solid tumors or lymphomas and liver dysfunction
PURPOSE This phase I trial is studying the side effects and best dose of ixabepilone in treating patients with advanced solid tumors or lymphomas and liver dysfunction
Detailed Description:
OBJECTIVES
Determine the levels of hepatic impairment at which dose modifications of ixabepilone are required in patients with advanced solid tumors or lymphomas and varying levels of liver dysfunction
Determine the effect of hepatic dysfunction on the plasma pharmacokinetics of this drug in these patients
Determine the toxic effects of this drug at varying levels of hepatic dysfunction in these patients
OUTLINE This is a dose-escalation multicenter study Patients are stratified according to liver function normal vs mild dysfunction vs moderate dysfunction vs severe dysfunction
Patients receive ixabepilone IV over 3 hours on day 1 Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of ixabepilone 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 Once the MTD is determined at least 6 but no more than 12 patients are treated at the recommended phase II dose
Patients are followed for 30 days
PROJECTED ACCRUAL A total of 12-84 patients 6-12 for stratum 1 2-18 for stratum 2 2-24 for stratum 3 and 2-30 for stratum 4 will be accrued for this study within 12 months
Determine the levels of hepatic impairment at which dose modifications of ixabepilone are required in patients with advanced solid tumors or lymphomas and varying levels of liver dysfunction
Determine the effect of hepatic dysfunction on the plasma pharmacokinetics of this drug in these patients
Determine the toxic effects of this drug at varying levels of hepatic dysfunction in these patients
OUTLINE This is a dose-escalation multicenter study Patients are stratified according to liver function normal vs mild dysfunction vs moderate dysfunction vs severe dysfunction
Patients receive ixabepilone IV over 3 hours on day 1 Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of ixabepilone 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 Once the MTD is determined at least 6 but no more than 12 patients are treated at the recommended phase II dose
Patients are followed for 30 days
PROJECTED ACCRUAL A total of 12-84 patients 6-12 for stratum 1 2-18 for stratum 2 2-24 for stratum 3 and 2-30 for stratum 4 will be accrued for this study within 12 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U10CA032102 | NIH | SWOG | httpsreporternihgovquickSearchU10CA032102 |
| U01CA076642 | NIH | None | None |
| P30CA016087 | NIH | None | None |
| S0355 | OTHER | None | None |