Chemotherapy in Treating Women With Metastatic Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00004046|
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 women who have metastatic breast cancer that has not responded to previous therapy.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: exatecan mesylate||Phase 2|
OBJECTIVES: I. Determine the antitumor activity of DX-8951f in women with metastatic adenocarcinoma of the breast who have failed prior therapy with an anthracycline and a taxane. II. Evaluate the quantitative and qualitative toxicities of this drug in these patients. III. Evaluate the pharmacokinetics of this drug in these patients.
OUTLINE: 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 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 Metastatic Adenocarcinoma of the Breast|
|Study Start Date :||June 1999|
|Actual Primary Completion Date :||April 2002|
|Actual Study Completion Date :||April 2002|
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): NCT00004046
|United States, Texas|
|University of Texas - MD Anderson Cancer Center|
|Houston, Texas, United States, 77030-4009|
|Study Chair:||Robert L. DeJager, MD, FACP||Daiichi Sankyo, Inc.|