Phase II Study of Gemcitabine in the Treatment of Patients With Metastatic Breast Cancer Previously Treated With Adriamycin and Taxol
gemcitabine hydrochloride
Breast Diseases+3
+ Neoplasms
+ Neoplasms by Site
Treatment Study
Summary
Study start date: June 1, 1998
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.30 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Memorial Sloan-Kettering Cancer Center
New York, United StatesOpen Memorial Sloan-Kettering Cancer Center in Google Maps