Breast Cancer Clinical Trial
Official title:
Phase I/II Study of Gemcitabine and Doxil Combination Chemotherapy in Patients With Advanced Solid Tumors (Phase I)/Breast Cancer (Phase II)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of gemcitabine and liposomal doxorubicin
in treating women who have metastatic breast cancer.
OBJECTIVES:
I. Determine the objective response rate, duration of response, time to disease progression,
and duration of survival of women with metastatic breast cancer when treated with gemcitabine
and doxorubicin HCl liposome.
II. Determine the qualitative and quantitative toxicity and reversibility of toxicity of this
treatment regimen in these patients.
OUTLINE: Patients receive gemcitabine intravenous (IV) over 30 minutes on days 1 and 8 and
doxorubicin HCl liposome IV over 2.5 hours on day 1. Treatment continues every 21 days in the
absence of disease progression or unacceptable toxicity. Patients are followed at 3 weeks.
PROJECTED ACCRUAL: A total of 22-46 patients will be accrued for this study within 20 months.
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