Gemcitabine in Treating Women With Metastatic Breast Cancer Previously Treated With Doxorubicin and Paclitaxel
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|ClinicalTrials.gov Identifier: NCT00003540|
Recruitment Status : Completed
First Posted : September 25, 2003
Last Update Posted : June 26, 2013
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 gemcitabine in treating women with metastatic breast cancer previously treated with doxorubicin and paclitaxel.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: gemcitabine hydrochloride||Phase 2|
- Determine the objective response rate to gemcitabine in women with metastatic breast cancer previously treated with two to four chemotherapy regimens, including doxorubicin and paclitaxel.
- Characterize the nature of toxicity of gemcitabine in this patient population.
- Determine the response duration to gemcitabine in this patient population.
OUTLINE: Patients receive gemcitabine IV over 30 minutes once weekly for 3 consecutive weeks (days 1, 8, and 15) followed by 1 week of rest. Treatment continues every 4 weeks in the absence of disease progression or unacceptable toxic effects.
Patients are followed until death.
PROJECTED ACCRUAL: A total of 14-30 patients will be accrued for this study within 13 months.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Official Title:||Phase II Study of Gemcitabine in the Treatment of Patients With Metastatic Breast Cancer Previously Treated With Adriamycin and Taxol|
|Study Start Date :||June 1998|
|Actual Primary Completion Date :||November 2002|
|Actual Study Completion Date :||November 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): NCT00003540
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Study Chair:||Violante E. Currie, MD||Memorial Sloan Kettering Cancer Center|