Expired Study
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New York, New York 10021


Purpose:

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.


Study summary:

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.


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


NCT ID:

NCT00003540


Primary Contact:

Study Chair
Violante E. Currie, MD
Memorial Sloan-Kettering Cancer Center


Backup Contact:

N/A


Location Contact:

New York, New York 10021
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 24, 2017

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