Bortezomib in Treating Patients With Advanced Cancer and Liver Dysfunction
|Hepatic Complications Malignant Neoplasm||Drug: bortezomib Other: pharmacological study||Phase 1|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Phase I Pharmacokinetic Study of PS-341 in Patients With Advanced Malignancies and Varying Degrees of Liver Dysfunction for the CTEPSponsored Organ Dysfunction Working Group|
- DLT [ Time Frame: 21 days ]
- MTD [ Time Frame: 21 days ]
|Study Start Date:||July 2004|
|Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Other Names:Other: pharmacological study
Other Name: pharmacological studies
I. Determine the maximum tolerated dose of bortezomib in patients with advanced malignancies and varying degrees of liver dysfunction.
II. Determine the safety and tolerability of this drug in these patients. III. Determine the pharmacokinetics and pharmacodynamics of this drug in these patients with mild, moderate, or severe liver insufficiency.
IV. Examine the dietary influences on bortezomib disposition and efficacy. V. Examine the influences of proteasome inhibition on CYP 450 activity.
OUTLINE: This is a multicenter, dose-escalation study. Patients are stratified according to hepatic function (normal vs mild dysfunction vs moderate dysfunction vs severe dysfunction).
Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11.
Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients per stratum receive escalating doses of bortezomib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.
[Note: Patients with normal hepatic function do not receive escalating doses of bortezomib.]
Please refer to this study by its ClinicalTrials.gov identifier: NCT00091117
|United States, California|
|City of Hope Medical Center|
|Duarte, California, United States, 91010|
|United States, Maryland|
|Johns Hopkins University|
|Baltimore, Maryland, United States, 21287-8936|
|United States, Michigan|
|Wayne State University|
|Detroit, Michigan, United States, 48202|
|Principal Investigator:||Patricia LoRusso||Wayne State University|