Breast Cancer Clinical Trial
Gemcitabine in Treating Women With Metastatic Breast Cancer Previously Treated With Doxorubicin and Paclitaxel
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.
Full 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.
Eligibility 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
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There is 1 Location for this study
New York New York, 10021, United States
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