Spots Global Cancer Trial Database for Oxaliplatin in Treating Patients With Advanced Cancer Plus Liver Dysfunction
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Trial Identification
Brief Title: Oxaliplatin in Treating Patients With Advanced Cancer Plus Liver Dysfunction
Official Title: Phase I Study of Oxaliplatin in Patients With Advanced Malignancies and Varying Degrees of Liver Dysfunction (Summary Last Modified 04/2000)
Study ID: NCT00005077
Interventions
Study Description
Brief Summary: 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.
Detailed Description: 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
USC/Norris Comprehensive Cancer Center, Los Angeles, California, United States
Beckman Research Institute, City of Hope, Los Angeles, California, United States
University of California Davis Cancer Center, Sacramento, California, United States
Walter Reed Army Medical Center, Washington, District of Columbia, United States
Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, United States
Albert Einstein Comprehensive Cancer Center, Bronx, New York, United States
NYU School of Medicine's Kaplan Comprehensive Cancer Center, New York, New York, United States
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
Ireland Cancer Center, Cleveland, Ohio, United States
University of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania, United States
University of Wisconsin Comprehensive Cancer Center, Madison, Wisconsin, United States
Contact Details
Name: James H. Doroshow, MD
Affiliation: City of Hope Comprehensive Cancer Center
Role: STUDY_CHAIR
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