S0355 Ixabepilone in Treating Patients With Advanced Solid Tumors or Lymphomas and Liver Dysfunction
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.
Small Intestine Cancer
Unspecified Adult Solid Tumor, Protocol Specific
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- dose defining [ Time Frame: Treatment delays >2 weeks constitute a DLT ] [ Designated as safety issue: Yes ]
- Progression [ Time Frame: 30 days after going off study ] [ Designated as safety issue: No ]20% increase in the sum of longest diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline.
- Symptomatic deterioration [ Time Frame: 30 days after going off study ] [ Designated as safety issue: Yes ]Global deterioration of health status requiring discontinuation of treatment without objective evidence of progression.
|Study Start Date:||October 2003|
|Study Completion Date:||December 2007|
|Primary Completion Date:||September 2006 (Final data collection date for primary outcome measure)|
Single-arm, dose-escalation of BMS-247550
BMS-247550 as a 3-hour infusion on Day 1 of a three-week cycle
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00049400
|United States, California|
|City of Hope Comprehensive Cancer Center|
|Duarte, California, United States, 91010-3000|
|USC/Norris Comprehensive Cancer Center and Hospital|
|Los Angeles, California, United States, 90089-9181|
|University of California Davis Cancer Center|
|Sacramento, California, United States, 95817|
|United States, Illinois|
|Cardinal Bernardin Cancer Center at Loyola University Medical Center|
|Maywood, Illinois, United States, 60153|
|United States, Kansas|
|Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center|
|Kansas City, Kansas, United States, 66160-7357|
|United States, Ohio|
|Cleveland Clinic Taussig Cancer Center|
|Cleveland, Ohio, United States, 44195|
|Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44106|
|Community Oncology Group at Cleveland Clinic Cancer Center|
|Independence, Ohio, United States, 44131|
|Cleveland Clinic - Wooster|
|Wooster, Ohio, United States, 44691|
|United States, Texas|
|Brooke Army Medical Center|
|Fort Sam Houston, Texas, United States, 78234|
|Wilford Hall Medical Center|
|Lackland AFB, Texas, United States, 78236|
|University of Texas Health Science Center at San Antonio|
|San Antonio, Texas, United States, 78229-3900|
|United States, Washington|
|St. Joseph Hospital Community Cancer Center|
|Bellingham, Washington, United States, 98225|
|Olympic Hematology and Oncology|
|Bremerton, Washington, United States, 98310|
|Skagit Valley Hospital Cancer Care Center|
|Mt. Vernon, Washington, United States, 98273|
|Fred Hutchinson Cancer Research Center|
|Seattle, Washington, United States, 98104|
|Group Health Central Hospital|
|Seattle, Washington, United States, 98104-1387|
|Harborview Medical Center|
|Seattle, Washington, United States, 98104|
|Swedish Cancer Institute at Swedish Medical Center - First Hill Campus|
|Seattle, Washington, United States, 98122-4307|
|University Cancer Center at University of Washington Medical Center|
|Seattle, Washington, United States, 98195-6043|
|North Puget Oncology at United General Hospital|
|Sedro-Wooley, Washington, United States, 98284|
|Cancer Care Northwest - Spokane South|
|Spokane, Washington, United States, 99202|
|Wenatchee Valley Medical Center|
|Wenatchee, Washington, United States, 98801-2028|
|Principal Investigator:||Angela Davies, MD||University of California, Davis|
|Principal Investigator:||Chris H. Takimoto, MD, PhD||Institute for Drug Development|