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Tracking Information | |||||||||
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First Received Date † | November 12, 2002 | ||||||||
Last Updated Date | July 23, 2008 | ||||||||
Start Date † | October 2003 | ||||||||
Current Primary Outcome Measures † | |||||||||
Original Primary Outcome Measures † | |||||||||
Change History | Complete list of historical versions of study NCT00049400 on ClinicalTrials.gov Archive Site | ||||||||
Current Secondary Outcome Measures † | |||||||||
Original Secondary Outcome Measures † | |||||||||
Descriptive Information | |||||||||
Brief Title † | Ixabepilone in Treating Patients With Advanced Solid Tumors or Lymphomas and Liver Dysfunction | ||||||||
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 | ||||||||
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. |
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Detailed Description | OBJECTIVES:
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. |
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Study Phase | Phase I | ||||||||
Study Type † | Interventional | ||||||||
Study Design † | Treatment | ||||||||
Condition † |
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Intervention † | Drug: ixabepilone | ||||||||
Study Arms / Comparison Groups | |||||||||
Publications * | |||||||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status † | Active, not recruiting | ||||||||
Enrollment † | 84 | ||||||||
Completion Date | |||||||||
Primary Completion Date | |||||||||
Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY: Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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Gender | Both | ||||||||
Ages | 18 Years and older | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts †† | |||||||||
Location Countries † | United States | ||||||||
Expanded Access Status | |||||||||
Administrative Information | |||||||||
NCT ID † | NCT00049400 | ||||||||
Responsible Party | |||||||||
Secondary IDs †† | SWOG-S0355, NCI-5707, NYU-0132 | ||||||||
Study Sponsor † | Southwest Oncology Group | ||||||||
Collaborators †† | National Cancer Institute (NCI) | ||||||||
Investigators † |
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Information Provided By | National Cancer Institute (NCI) | ||||||||
Verification Date | July 2006 | ||||||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |