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A Phase II Study of CT-2584 Mesylate in Patients With Hormone Refractory Prostate Cancer (NCT00004026)

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. CT-2584 may stop the growth of prostate cancer by stopping blood flow to the tumor. PURPOSE: Randomized phase II trial to study the effectiveness of CT-2584 in treating patients who have metastatic prostate cancer that has not responded to previous therapy.
  • Drug: CT-2584
    • Drug: chemotherapy
      Ages eligible for Study
      18 Years and older
      Genders eligible for Study
      Male
      Accepts Healthy Volunteers
      No
      OBJECTIVES: I. Compare the efficacy, safety, and pharmacokinetics of 2 different treatment schedules of CT-2584 in patients with hormone refractory, metastatic adenocarcinoma of the prostate.

      OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms: Arm I: Patients receive CT-2584 IV over 6 hours daily for 3 days every 3 weeks. Arm II: Patients receive CT-2584 IV over 6 hours once every 7 days for 3 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

      PROJECTED ACCRUAL: Approximately 80 patients will be accrued for this study.

      7 locations

      United States (7)
      • Jonsson Comprehensive Cancer Center, UCLA
        Not specified
        Los Angeles, California, United States, 90095-1781
      • UCSF Cancer Center and Cancer Research Institute
        Not specified
        San Francisco, California, United States, 94115-0128
      • Stanley Scott Cancer Center
        Not specified
        New Orleans, Louisiana, United States, 70112
      • Johns Hopkins Oncology Center
        Not specified
        Baltimore, Maryland, United States, 21287
      • Our Lady of Mercy Medical Center
        Not specified
        Bronx, New York, United States, 10466
      • Herbert Irving Comprehensive Cancer Center
        Not specified
        New York, New York, United States, 10032
      • University of Washington Medical Center
        Not specified
        Seattle, Washington, United States, 98195-6043
      Status:
      unknown
      Type:
      Interventional
      Phase:
      Start:
      30 November, 1998
      Updated:
      05 February, 2009
      Participants:
      80
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