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Home > "O" Clinical Trials Conditions > Oxaliplatin in Treating Patients With Advanced Cancer Plus Liver Dysfunction  Oxaliplatin in Treating Patients With Advanced Cancer Plus Liver Dysfunction
Oxaliplatin in Treating Patients With Advanced Cancer Plus Liver Dysfunction
For Condition: unspecified adult solid tumor, protocol specific
Status: Completed
Sponsor(s): National Cancer Institute (NCI) , Beckman Research Institute
Synopsis: 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.
Details: 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. PROTOCOL 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed metastatic or unresectable malignancy for which no curative or palliative treatment exists - No brain metastases --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 --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 - 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)
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JamesDoroshow, Study Chair, Beckman Research Institute
Ireland Cancer Center
Cleveland, Ohio, 44106-5065
United States
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033-0800
United States
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15213
United States
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York City, New York, 10016
United States
University of California Davis Cancer Center
Sacramento, California, 95817
United States
Albert Einstein Comprehensive Cancer Center
Bronx, New York, 10461
United States
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792
United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307-5000
United States
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201
United States
Beckman Research Institute, City of Hope
Los Angeles, California, 91010
United States
Additional Information:
Study ID Numbers: CDR0000067684; CHNMC-PHI-26,NCI-T99-0050,CHNMC-IRB-99108,NCI-00-C-0172,NCI-NMOB-B00-033,PCI-99105
Study Start Date: February 2000
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005077
Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
1. Phase I Study of Carboplatin and Gemcitabine in Patients With Advanced Solid Tumors
2. DHA-Paclitaxel With or Without Gemcitabine in Treating Patients With Advanced Solid Tumors or Unresectable Pancreatic Cancer
3. GW786034 in Treating Patients With Advanced Solid Tumors
4. Combination Chemotherapy in Treating Patients With Advanced Solid Tumors
5. Vaccine Therapy in Treating Patients With Metastatic Solid Tumors
Related Studies:
Other unspecified adult solid tumor, protocol specific Clinical Trials
Other Ohio Clinical Trials
Other Cleveland Clinical Trials
Oxaliplatin in Treating Patients With Advanced Cancer Plus Liver Dysfunction
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