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Home > "L" Clinical Trials Conditions > Liposomal Doxorubicin and Trastuzumab in Treating Women With Advanced Breast Cancer  Liposomal Doxorubicin and Trastuzumab in Treating Women With Advanced Breast Cancer
Liposomal Doxorubicin and Trastuzumab in Treating Women With Advanced Breast Cancer
For Condition: stage 4 breast cancer,recurrent breast cancer
Status: Recruiting
Sponsor(s): Kaplan Cancer Center , National Cancer Institute (NCI)
Synopsis: 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 liposomaldoxorubicin and trastuzumab in treating women who have advanced breast cancer.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MatthewVolm, Study Chair, Kaplan Cancer Center
NYU School of Medicine's Kaplan Comprehensive Cancer Center *Recruiting*
New York City, New York, 10016
United States
Recruiting Franco Muggia 212-263-6485
Additional Information:
Study ID Numbers: CDR0000068331; ALZA-00-001-ii,NCI-G00-1878,NYU-0012
Study Start Date:
Record last reviewed: December 2000
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006825
Other Recurrent Breast Cancer Studies:
1. Capecitabine and Tipifarnib in Treating Women With Taxane-Resistant Metastatic Breast Cancer
2. Marimastat or No Further Therapy in Treating Women With Metastatic Breast Cancer That Is Responding or Stable Following Chemotherapy
3. Drug Resistance Inhibition in Treating Patients With Recurrent or Metastatic Breast Cancer
4. Paclitaxel With or Without Gemcitabine in Treating Women With Advanced Breast Cancer
5. Antineoplaston Therapy in Treating Women With Stage IV Breast Cancer
Related Studies:
Other recurrent breast cancer Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
Liposomal Doxorubicin and Trastuzumab in Treating Women With Advanced Breast Cancer
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