Spots Global Cancer Trial Database for Chemotherapy in Treating Patients With Metastatic Kidney Cancer
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Trial Identification
Brief Title: Chemotherapy in Treating Patients With Metastatic Kidney Cancer
Official Title: Phase II Open-Label Study of Taxoprexin (DHA-Paclitaxel) Injection by 2-Hour Intravenous Infusion In Patients With Metastatic, Locally Advanced, or Unresectable Renal Cell Carcinoma
Study ID: NCT00024388
Conditions
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 II trial to study the effectiveness of DHA-paclitaxel in treating patients who have locally advanced, metastatic, or unresectable kidney cancer.
Detailed Description: OBJECTIVES: I. Determine the tumor response rate, duration of response, and time to disease progression in patients with locally advanced, metastatic, or unresectable renal cell cancer treated with DHA-paclitaxel. II. Determine the overall survival of patients treated with this drug. III. Determine the toxicity profile of this drug in these patients. IV. Assess the quality of life of patients treated with this drug. 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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
Contact Details
Name: Ronald M. Bukowski, MD
Affiliation: The Cleveland Clinic
Role: STUDY_CHAIR
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