Oxaliplatin in Treating Patients With Advanced Cancer Plus Liver Dysfunction
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of oxaliplatin in treating patients who have advanced cancer plus liver dysfunction.
|Unspecified Adult Solid Tumor, Protocol Specific||Drug: oxaliplatin||Phase 1|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase I Study of Oxaliplatin in Patients With Advanced Malignancies and Varying Degrees of Liver Dysfunction (Summary Last Modified 04/2000)|
|Study Start Date:||February 2000|
OBJECTIVES: I. Determine the maximum tolerated dose of oxaliplatin in patients with advanced malignancies and varying degrees of liver dysfunction. II. Determine the effects of hepatic dysfunction on the plasma pharmacokinetics and pharmacodynamics of oxaliplatin in these patients.
OUTLINE: This is a dose escalation, multicenter study. Patients are stratified according to liver function as defined by the following: Group A: Normal liver function - Bilirubin, SGOT, and alkaline phosphatase no greater than upper limit of normal (ULN) Group B: Mild liver dysfunction - Bilirubin no greater than ULN; SGOT greater than ULN to 2.5 times ULN and/or alkaline phosphatase greater than ULN to 5 times ULN Group C: Moderate liver function - Bilirubin greater than ULN to 3.0 mg/dL and/or SGOT greater than 2.5 times ULN and/or alkaline phosphatase greater than 5 times normal Group D: Severe liver dysfunction - Bilirubin greater than 3.1 mg/dL and any SGOT or alkaline phosphatase Group E: Patients who have received a liver transplant Patients receive oxaliplatin IV over 2 hours on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients in groups B, C, and D receive escalating doses of oxaliplatin 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.
PROJECTED ACCRUAL: Approximately 72 patients will be accrued for this study within 1.5 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005077
|United States, California|
|USC/Norris Comprehensive Cancer Center|
|Los Angeles, California, United States, 90033-0800|
|Beckman Research Institute, City of Hope|
|Los Angeles, California, United States, 91010|
|University of California Davis Cancer Center|
|Sacramento, California, United States, 95817|
|United States, District of Columbia|
|Walter Reed Army Medical Center|
|Washington, District of Columbia, United States, 20307-5000|
|United States, Michigan|
|Barbara Ann Karmanos Cancer Institute|
|Detroit, Michigan, United States, 48201|
|United States, New York|
|Albert Einstein Comprehensive Cancer Center|
|Bronx, New York, United States, 10461|
|NYU School of Medicine's Kaplan Comprehensive Cancer Center|
|New York, New York, United States, 10016|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|United States, Ohio|
|Ireland Cancer Center|
|Cleveland, Ohio, United States, 44106-5065|
|United States, Pennsylvania|
|University of Pittsburgh Cancer Institute|
|Pittsburgh, Pennsylvania, United States, 15213|
|United States, Wisconsin|
|University of Wisconsin Comprehensive Cancer Center|
|Madison, Wisconsin, United States, 53792|
|Study Chair:||James H. Doroshow, MD||City of Hope Comprehensive Cancer Center|