Oxaliplatin in Treating Patients With Advanced Cancer Plus Liver Dysfunction
NCT ID: NCT00005077
Last Updated: 2010-01-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
INTERVENTIONAL
2000-02-29
Brief Summary
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PURPOSE: Phase I trial to study the effectiveness of oxaliplatin in treating patients who have advanced cancer plus liver dysfunction.
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Detailed Description
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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.
Conditions
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Study Design
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TREATMENT
Interventions
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oxaliplatin
Eligibility Criteria
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Inclusion Criteria
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: At least 2 months Hematopoietic: Platelet count at least 100,000/mm3 WBC at least 3,000/mm3 OR Absolute neutrophil count at least 1,500/mm3 Hepatic: Abnormal liver function allowed Renal: Creatinine normal OR Creatinine clearance at least 60 mL/min Cardiovascular: No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia Other: No clinically significant neuropathy Not pregnant or nursing Fertile patients must use effective contraception No history of allergy to platinum compounds or antiemetics which may be used with study No uncontrolled concurrent illness (e.g., ongoing or active infection)
PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent colony stimulating factors during first course of study Chemotherapy: No more than 3 prior regimens of chemotherapy At least 6 weeks since prior platinum chemotherapy At least 4 weeks since other prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to more than 30% of bone marrow Surgery: At least 10 days since placement of biliary shunt Other: No other concurrent investigational agents No concurrent antiretroviral therapy (HAART) in HIV positive patients
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
City of Hope Medical Center
OTHER
Principal Investigators
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James H. Doroshow, MD
Role: STUDY_CHAIR
City of Hope Comprehensive Cancer Center
Locations
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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 D.C., District of Columbia, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 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
Albert Einstein Comprehensive Cancer Center
The Bronx, 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
Countries
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Other Identifiers
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CHNMC-PHI-26
Identifier Type: -
Identifier Source: secondary_id
CHNMC-IRB-99108
Identifier Type: -
Identifier Source: secondary_id
NCI-00-C-0172
Identifier Type: -
Identifier Source: secondary_id
NCI-NMOB-B00-033
Identifier Type: -
Identifier Source: secondary_id
PCI-99105
Identifier Type: -
Identifier Source: secondary_id
NCI-T99-0050
Identifier Type: -
Identifier Source: secondary_id
CDR0000067684
Identifier Type: -
Identifier Source: org_study_id
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