S0355 Ixabepilone in Treating Patients With Advanced Solid Tumors or Lymphomas and Liver Dysfunction
- Conditions
- Small Intestine CancerUnspecified Adult Solid Tumor, Protocol SpecificLymphoma
- Interventions
- Registration Number
- NCT00049400
- Lead Sponsor
- SWOG Cancer Research Network
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 78
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description treatment BMS-247550 Single-arm, dose-escalation of BMS-247550
- Primary Outcome Measures
Name Time Method dose defining Treatment delays >2 weeks constitute a DLT
- Secondary Outcome Measures
Name Time Method Progression 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 30 days after going off study Global deterioration of health status requiring discontinuation of treatment without objective evidence of progression.
Trial Locations
- Locations (23)
City of Hope Comprehensive Cancer Center
🇺🇸Duarte, California, United States
Community Oncology Group at Cleveland Clinic Cancer Center
🇺🇸Independence, Ohio, United States
Brooke Army Medical Center
🇺🇸Fort Sam Houston, Texas, United States
Cancer Care Northwest - Spokane South
🇺🇸Spokane, Washington, United States
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
Wilford Hall Medical Center
🇺🇸Lackland AFB, Texas, United States
St. Joseph Hospital Community Cancer Center
🇺🇸Bellingham, Washington, United States
Olympic Hematology and Oncology
🇺🇸Bremerton, Washington, United States
Skagit Valley Hospital Cancer Care Center
🇺🇸Mt. Vernon, Washington, United States
North Puget Oncology at United General Hospital
🇺🇸Sedro-Wooley, Washington, United States
Case Comprehensive Cancer Center
🇺🇸Cleveland, Ohio, United States
Cleveland Clinic - Wooster
🇺🇸Wooster, Ohio, United States
USC/Norris Comprehensive Cancer Center and Hospital
🇺🇸Los Angeles, California, United States
Group Health Central Hospital
🇺🇸Seattle, Washington, United States
University of California Davis Cancer Center
🇺🇸Sacramento, California, United States
University of Texas Health Science Center at San Antonio
🇺🇸San Antonio, Texas, United States
Cardinal Bernardin Cancer Center at Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
Cleveland Clinic Taussig Cancer Center
🇺🇸Cleveland, Ohio, United States
Fred Hutchinson Cancer Research Center
🇺🇸Seattle, Washington, United States
Wenatchee Valley Medical Center
🇺🇸Wenatchee, Washington, United States
Harborview Medical Center
🇺🇸Seattle, Washington, United States
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
🇺🇸Seattle, Washington, United States
University Cancer Center at University of Washington Medical Center
🇺🇸Seattle, Washington, United States