Breast Cancer
Conditions
Keywords
stage IV breast cancer
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.
Interventions
DRUGgemcitabine hydrochloride
DRUGpegylated liposomal doxorubicin hydrochloride
Sponsors
Pharmatech Oncology
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed metastatic breast cancer * Measurable disease * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age: * 18 and over Sex: * Female Menopausal status: * Not specified Performance status: * Karnofsky 60-100% Life expectancy: * At least 3 months Hematopoietic: * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 9 g/dL * Absolute neutrophil count at least 1,500/mm\^3 * No impaired bone marrow function Hepatic: * Bilirubin no greater than 2 mg/dL * AST and ALT no greater than 2 times upper limit of normal (ULN) * Alkaline phosphatase no greater than 2 times ULN (unless attributed to tumor) * No impaired hepatic function Renal: * Creatinine no greater than 2.5 mg/dL OR * Creatinine clearance at least 60 mL/min * No impaired renal function Cardiovascular: * No prior cardiac disease within the past 5 years OR * LVEF at least 50% Other: * No prior uncontrolled seizures * No uncontrolled systemic infection * No anthracycline resistance * No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior trastuzumab (Herceptin) Chemotherapy: * Prior adjuvant therapy with anthracycline of no more than 320 mg/m\^2 allowed Endocrine therapy: * Not specified Radiotherapy: * No prior radiotherapy to more than 1/3 of hematopoietic sites Surgery: * Not specified Other: * At least 30 days since prior investigational medications and recovered * No more than 1 prior treatment regimen for metastatic disease
Countries
United States
Outcome results
None listed