Gemcitabine and Liposomal Doxorubicin in Treating Women With Metastatic Breast Cancer
- Conditions
- Breast Cancer
- Registration Number
- NCT00005991
- Lead Sponsor
- M.D. Anderson Cancer Center
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 76
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Texas - MD Anderson Cancer Center
🇺🇸Houston, Texas, United States