Gemcitabine in Treating Women With Metastatic Breast Cancer Previously Treated With Doxorubicin and Paclitaxel

Study Overview
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Brief Summary
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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
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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.

Official Title
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Phase II Study of Gemcitabine in the Treatment of Patients With Metastatic Breast Cancer Previously Treated With Adriamycin and Taxol

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: gemcitabine hydrochloride


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: gemcitabine hydrochloride|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IV breast cancer, recurrent breast cancer