Expired Study
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New York, New York 10016


Purpose:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining chemotherapy with monoclonal antibody therapy may kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of liposomal doxorubicin and trastuzumab in treating women who have advanced breast cancer.


Study summary:

OBJECTIVES: - Determine the toxicity, including cardiac toxicity, of doxorubicin HCl liposome and trastuzumab (Herceptin) in women with advanced HER-2/neu-overexpressing breast cancer. - Determine the efficacy of this regimen in these patients. OUTLINE: Patients receive doxorubicin HCl liposome IV over 1 hour on day 1, followed by trastuzumab (Herceptin) IV over 30-90 minutes on days 1, 8, and 15. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.


Criteria:

DISEASE CHARACTERISTICS: - Histologically proven breast cancer - Metastatic disease OR - Locoregional relapse following optimal adjuvant therapy and regional treatment - HER-2/neu overexpression (3+ by immunohistochemistry OR gene amplification by FISH) - Hormone receptor status: - Not specified PATIENT CHARACTERISTICS: Age: - 18 and over Sex: - Female Menopausal status: - Not specified Performance status: - ECOG 0-2 Life expectancy: - Not specified Hematopoietic: - Absolute neutrophil count at least 1,500/mm3 - Platelet count at least 100,000/mm3 - Hemoglobin at least 10 g/dL Hepatic: - SGOT and SGPT no greater than 3 times upper limit of normal (ULN) - Alkaline phosphatase no greater than 2 times ULN unless documented to be arising from bone - Bilirubin no greater than 1.5 times ULN Renal: - BUN less than 1.5 times ULN - Creatinine less than 1.5 times ULN Cardiovascular: - LVEF normal by radioisotope method - No history of congestive cardiac failure, myocardial infarction, cardiac arrhythmia, or ischemic heart disease requiring medication Other: - Not pregnant or nursing - Fertile patients must use effective contraception - No known sensitivity to benzyl alcohol - No other prior malignancy except adequately treated nonmelanomatous skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: - See Disease Characteristics Biologic therapy: - Not specified Chemotherapy: - No prior doxorubicin greater than 240 mg/m2 Endocrine therapy: - Not specified Radiotherapy: - Prior radiotherapy to left breast or chest wall allowed Surgery: - Not specified


NCT ID:

NCT00006825


Primary Contact:

Study Chair
Matthew D. Volm, MD
New York University School of Medicine


Backup Contact:

N/A


Location Contact:

New York, New York 10016
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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