CT-2584 in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Previous Therapy
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.
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Official Title:||A Phase II Study of CT-2584 Mesylate in Patients With Hormone Refractory Prostate Cancer|
|Study Start Date:||December 1998|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004026
|United States, California|
|Jonsson Comprehensive Cancer Center, UCLA|
|Los Angeles, California, United States, 90095-1781|
|UCSF Cancer Center and Cancer Research Institute|
|San Francisco, California, United States, 94115-0128|
|United States, Louisiana|
|Stanley Scott Cancer Center|
|New Orleans, Louisiana, United States, 70112|
|United States, Maryland|
|Johns Hopkins Oncology Center|
|Baltimore, Maryland, United States, 21287|
|United States, New York|
|Our Lady of Mercy Medical Center|
|Bronx, New York, United States, 10466|
|Herbert Irving Comprehensive Cancer Center|
|New York, New York, United States, 10032|
|United States, Washington|
|University of Washington Medical Center|
|Seattle, Washington, United States, 98195-6043|
|Study Chair:||Carolyn Paradise, MD||CTI BioPharma|