An Open-Label, Single-Arm, Phase II Study of Liposomal Doxorubicin (Doxil) and Gemcitabine in the Treatment of Women With Metastatic Breast Cancer
- 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
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
United States: Federal Government
|Montgomery Cancer Center||Montgomery, Alabama 36106-3657|
|South Carolina Oncology Associates||Columbia, South Carolina 29201|
|Oncology-Hematology Associates, P.A.||Clinton, Maryland 20735|
|California Cancer Medical Center||West Covina, California 91790|
|Pharmatech Oncology||Denver, Colorado 80203|