Gemcitabine and Liposomal Doxorubicin in Treating 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. 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.
Drug: gemcitabine hydrochloride
Drug: pegylated liposomal doxorubicin hydrochloride
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I/II Study of Gemcitabine and Doxil Combination Chemotherapy in Patients With Advanced Solid Tumors (Phase I)/Breast Cancer (Phase II)|
|Study Start Date:||April 2000|
|Study Completion Date:||February 2003|
|Primary Completion Date:||February 2003 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005991
|United States, Texas|
|University of Texas - MD Anderson Cancer Center|
|Houston, Texas, United States, 77030-4009|
|Study Chair:||Edgardo Rivera, MD||M.D. Anderson Cancer Center|