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



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

For Condition: recurrent breast cancer,stage 4 breast cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Memorial Sloan-Kettering Cancer Center
Synopsis: 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.
Details: OBJECTIVES: I. 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. II. Characterize the nature of toxicity of gemcitabine in this patient population. III. Determine the response duration to gemcitabine in this patient population. PROTOCOL 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:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: 
Protocol Entry Criteria: PROTOCOL ENTRY 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 --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 --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/mm3; Platelet count at least 100,000/mm3 - 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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
ViolanteCurrie,  Study Chair,  Memorial Sloan-Kettering Cancer Center

Memorial Sloan-Kettering Cancer Center
New York City,  New York,  10021
United States
 


Additional Information:
Study ID Numbers:  CDR0000066594;  MSKCC-98030,NCI-G98-1474
Study Start Date: June 1998
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003540

Other Stage 4 Breast Cancer Studies:
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2. Celecoxib and Trastuzumab in Treating Women With Metastatic Breast Cancer

3. Tipifarnib and Fulvestrant as Second-Line Therapy in Treating Postmenopausal Women With Hormone Receptor-Positive Inoperable Locally Advanced or Metastatic Breast Cancer With Progressive Disease After Previous First-Line Endocrine Therapy

4. Diagnostic Procedures in Women With Locally Advanced Breast Cancer Who Are Receiving Chemotherapy Before Breast Cancer Surgery

5. Neoadjuvant Docetaxel in Treating Women With Newly Diagnosed Breast Cancer

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