Chemotherapy in Treating Patients With Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT00004045|
Recruitment Status : Completed
First Posted : April 15, 2004
Last Update Posted : May 16, 2012
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 DX-8951f in treating patients who have metastatic prostate cancer that has not responded to hormone therapy.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: exatecan mesylate||Phase 2|
OBJECTIVES: I. Determine the antitumor activity of DX-8951f as measured by PSA response in patients with hormone refractory prostate cancer. II. Determine the antitumor activity of this drug in the subpopulation of these patients with measurable disease. III. Evaluate the quantitative and qualitative toxicities of this drug in these patients. IV. Evaluate the pharmacokinetics of this drug in these patients.
OUTLINE: This is a multicenter study. Patients receive DX-8951f IV over 30 minutes daily for 5 days. Courses repeat every 21 days. Treatment continues in the absence of unacceptable toxicity or disease progression. Patients with no evidence of PSA decrease by the start of course 3 receive no further treatment. Patients are followed every 3 months until death.
PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||A Phase II Study of Intravenous DX-8951f Administered Daily for Five Days Every Three Weeks to Patients With Hormone-Refractory Prostate Cancer|
|Study Start Date :||June 1999|
|Actual Primary Completion Date :||August 2001|
|Actual Study Completion Date :||August 2001|
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): NCT00004045
|United States, Texas|
|U.S. Oncology Research Inc.|
|Houston, Texas, United States, 77060|
|Institute for Drug Development|
|San Antonio, Texas, United States, 78245-3217|
|Study Chair:||Robert L. DeJager, MD, FACP||Daiichi Sankyo, Inc.|