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Phase II Study of Weekly Docetaxel (Taxotere) in Hormone Refractory Metastatic Prostate Cancer (NCT00003781)

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial of docetaxel in treating patients who have stage IV prostate cancer that has not responded to hormone therapy.
  • Drug: docetaxel
    • Procedure: pain therapy
      • Procedure: quality-of-life assessment
        Ages eligible for Study
        18 Years to 120 Years
        Genders eligible for Study
        Male
        Accepts Healthy Volunteers
        No
        OBJECTIVES: I. Evaluate the efficacy of weekly docetaxel as measured by disease response, strength and duration of pain reduction, and either a decrease in analgesic use without an increase in pain, or a decrease in PSA, in patients with hormone refractory metastatic prostate cancer. II. Assess the efficacy of this regimen in terms of survival in this patient population. III. Evaluate the effect of this regimen on quality of life in these patients. IV. Determine qualitative and quantitative toxicities of this regimen in these patients.

        OUTLINE: Patients receive docetaxel IV over 15-30 minutes weekly for 6 weeks. Courses repeat every 8 weeks. Therapy continues in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at weeks 1, 3, 5, and 7 of each course, and a daily pain medication diary is maintained during treatment. Patients are followed for 1 month or until resolution of toxicity, then every 3 months until death.

        PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.

        1 locations

        United States (1)
        • OHSU Knight Cancer Institute
          Portland, Oregon, United States, 97239
        Status:
        completed
        Type:
        Interventional
        Phase:
        Start:
        30 November, 1998
        Updated:
        25 April, 2017
        Participants:
        25
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