Breast Cancer Clinical Trial
Official title:
An Open-Label, Single-Arm, Phase II Study of Liposomal Doxorubicin (Doxil) and Gemcitabine in the Treatment of Women With Metastatic Breast Cancer
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 combining liposomal doxorubicin with
gemcitabine in treating women who have metastatic breast cancer.
OBJECTIVES:
- Determine the objective response rate in women with metastatic breast cancer treated
with doxorubicin HCl liposome and gemcitabine.
- Determine the duration of response, time to disease progression, and duration of
survival of patients treated with this regimen.
- Determine the quality of life of patients treated with this regimen.
- Determine the quantitative toxicity of this regimen, in terms of incidence, type, and
severity, in these patients.
OUTLINE: This is a multicenter study.
Patients receive doxorubicin HCl liposome IV over 1 hour on day 1 and gemcitabine IV over 30
minutes on days 1 and 8. Courses repeat every 28 days in the absence of disease progression
or unacceptable toxicity. Patients who achieve a complete response (CR) receive 2 courses
beyond documentation of CR.
Quality of life is assessed at baseline, on day 1 of each course, and then at the end of
study.
Patients are followed at 4 weeks and then every 3 months for 5 years.
PROJECTED ACCRUAL: A total of 75 patients will be accrued for this study.
;
Primary Purpose: Treatment
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