Kidney Cancer Clinical Trial
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
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.
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.
;
Primary Purpose: Treatment
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