Liposomal Doxorubicin and Gemcitabine in Treating Women With Metastatic Breast Cancer
- Conditions
- Breast Cancer
- Registration Number
- NCT00027989
- Lead Sponsor
- Pharmatech Oncology
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (5)
Montgomery Cancer Center
🇺🇸Montgomery, Alabama, United States
California Cancer Medical Center
🇺🇸West Covina, California, United States
Pharmatech Oncology
🇺🇸Denver, Colorado, United States
Oncology-Hematology Associates, P.A.
🇺🇸Clinton, Maryland, United States
South Carolina Oncology Associates
🇺🇸Columbia, South Carolina, United States
Montgomery Cancer Center🇺🇸Montgomery, Alabama, United States