CT-2584 in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Previous Therapy
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|ClinicalTrials.gov Identifier: NCT00004026|
Recruitment Status : Unknown
Verified June 2007 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : August 27, 2004
Last Update Posted : February 9, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: CT-2584 Drug: chemotherapy||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Official Title:||A Phase II Study of CT-2584 Mesylate in Patients With Hormone Refractory Prostate Cancer|
|Study Start Date :||December 1998|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|