Breast Cancer
Conditions
Keywords
stage IV breast cancer, recurrent 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 gemcitabine in treating women with metastatic breast cancer previously treated with doxorubicin and paclitaxel.
Detailed description
OBJECTIVES: * Determine the objective response rate to gemcitabine in women with metastatic breast cancer previously treated with two to four chemotherapy regimens, including doxorubicin and paclitaxel. * Characterize the nature of toxicity of gemcitabine in this patient population. * Determine the response duration to gemcitabine in this patient population. OUTLINE: Patients receive gemcitabine IV over 30 minutes once weekly for 3 consecutive weeks (days 1, 8, and 15) followed by 1 week of rest. Treatment continues every 4 weeks in the absence of disease progression or unacceptable toxic effects. Patients are followed until death. PROJECTED ACCRUAL: A total of 14-30 patients will be accrued for this study within 13 months.
Interventions
DRUGgemcitabine hydrochloride
Sponsors
National Cancer Institute (NCI)
Memorial Sloan Kettering Cancer Center
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically confirmed metastatic breast cancer * Bidimensionally measurable disease * No bone scan abnormalities alone * Lytic lesions in conjunction with bone scan abnormalities allowed * No pure blastic bone metastases * No pleural or peritoneal effusions * No previously irradiated lesions * Must have received 2-4 prior chemotherapy regimens, including paclitaxel and doxorubicin, for breast cancer * Brain metastases allowed if other measurable disease exists * No uncontrolled or life threatening brain lesions * No carcinomatous meningitis * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age: * 18 and over Sex: * Female Menopausal status: * Not specified Performance status: * Karnofsky 60-100% Life expectancy: * Not specified Hematopoietic: * Granulocyte count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * AST/ALT no greater than 5 times upper limit of normal Renal: * Calcium no greater than 11.0 mg/dL Other: * Not pregnant * Negative pregnancy test * No history of other malignancy except carcinoma in situ of the cervix or curatively treated nonmelanoma skin cancer * No other serious medical illnesses, including severe infection and severe malnutrition PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * See Disease Characteristics * At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas and mitomycin) and recovered * No other concurrent chemotherapy Endocrine therapy: * Prior hormonal therapies for stage IV disease and/or adjuvant therapy allowed * At least 3 weeks since prior hormonal therapy Radiotherapy: * See Disease Characteristics * No prior radiotherapy to greater than 30% of the marrow bearing bone * At least 4 weeks since prior radiotherapy and recovered * No concurrent radiotherapy to the only measurable lesion Surgery: * Recovered from prior surgery * No concurrent surgery to the only measurable lesion Other: * No concurrent nonprotocol treatment
Countries
United States
Outcome results
None listed