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.
|Lymphoma Small Intestine Cancer Unspecified Adult Solid Tumor, Protocol Specific||Drug: BMS-247550||Phase 1|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (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 ]
- Progression [ Time Frame: 30 days after going off study ]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 ]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|
|Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44106|
|Cleveland Clinic Taussig Cancer Center|
|Cleveland, Ohio, United States, 44195|
|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|
|Group Health Central Hospital|
|Seattle, Washington, United States, 98104-1387|
|Fred Hutchinson Cancer Research Center|
|Seattle, Washington, United States, 98104|
|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|