Chemotherapy in Treating Patients With Metastatic Kidney Cancer
NCT ID: NCT00024388
Last Updated: 2008-07-24
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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UNKNOWN
PHASE2
INTERVENTIONAL
2001-04-30
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of DHA-paclitaxel in treating patients who have locally advanced, metastatic, or unresectable kidney cancer.
Detailed Description
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OUTLINE: This is a multicenter study. Patients receive DHA-paclitaxel IV over 2 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, every 2 courses, and at completion of treatment. Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 21-50 patients will be accrued for this study.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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DHA-paclitaxel
Eligibility Criteria
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Inclusion Criteria
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT or SGPT no greater than 2.5 times ULN Renal: Creatinine no greater than 2.5 mg/dL Cardiovascular: No uncontrolled ventricular arrhythmia No myocardial infarction within the past 3 months No superior vena cava syndrome Neurologic: No peripheral neuropathy greater than grade 1 No uncontrolled major seizure disorder No spinal cord compression Other: No other prior malignancy except: Curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix OR Cancer curatively treated with surgery alone that has not recurred for more than 5 years No concurrent serious infection requiring parenteral therapy No unstable or serious concurrent medical conditions No psychiatric disorder that would preclude study Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 6 months after study
PRIOR CONCURRENT THERAPY: Biologic therapy: At least 28 days since prior immunotherapy No concurrent immunotherapy Chemotherapy: No prior chemotherapy for advanced disease No prior taxanes At least 28 days since prior chemotherapy No other concurrent chemotherapy Endocrine therapy: At least 28 days since prior hormonal therapy No concurrent hormonal therapy Radiotherapy: At least 28 days since prior large-field radiotherapy No concurrent radiotherapy Surgery: At least 14 days since prior major surgery Other: Concurrent bisphosphonates allowed if on stable dose for at least 30 days prior to study No other concurrent anticancer therapy
18 Years
ALL
No
Sponsors
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Theradex
INDUSTRY
Principal Investigators
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Ronald M. Bukowski, MD
Role: STUDY_CHAIR
The Cleveland Clinic
Locations
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Arizona Oncology Associates
Tucson, Arizona, United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States
Lucille Parker Markey Cancer Center, University of Kentucky
Lexington, Kentucky, United States
Louisiana State University Health Sciences Center - Shreveport
Shreveport, Louisiana, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
Herbert Irving Comprehensive Cancer Center
New York, New York, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States
Countries
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Other Identifiers
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THERADEX-P01-00-07
Identifier Type: -
Identifier Source: secondary_id
CCF-IRB-4046
Identifier Type: -
Identifier Source: secondary_id
PROTARGA-P01-00-07
Identifier Type: -
Identifier Source: secondary_id
CDR0000068928
Identifier Type: -
Identifier Source: org_study_id