Phase I/II Study of Gemcitabine and Doxil Combination Chemotherapy in Patients With Advanced Solid Tumors (Phase I)/Breast Cancer (Phase II)
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
PROJECTED ACCRUAL: A total of 22-46 patients will be accrued for this study within 20
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Edgardo Rivera, MD
M.D. Anderson Cancer Center
United States: Institutional Review Board
|University of Texas - MD Anderson Cancer Center||Houston, Texas 77030-4009|