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Chemotherapy in Treating Patients With Breast Cancer



Chemotherapy in Treating Patients With Breast Cancer

For Condition: stage 3B breast cancer,Male Breast Cancer,stage 4 breast cancer,recurrent breast cancer,stage 3A breast cancer
Status: Completed
Sponsor(s): National Cancer Institute (NCI) , Kaplan 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 I/II trial to study the effectiveness of annamycin liposomal in treating patients who have locally advanced or metastatic breast cancer that has not responded to previous chemotherapy.
Details: OBJECTIVES: I. Determine the observed anti-tumor activity of annamycin liposomal in patients with anthracycline-resistant locally advanced or metastatic breast cancer. II. Determine the qualitative and quantitative toxicity and reversibility of toxicity of this regimen in these patients. III. Determine the clinical pharmacology of this regimen in these patients. IV. Determine the rationale for the dose and chosen schedule of this regimen in these patients. PROTOCOL OUTLINE: Patients receive annamycin liposomal IV over 60 minutes on day 1. Treatment continues every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 14-30 patients will be accrued for this study within 7-30 months.
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: 
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Diagnosis of locally advanced or metastatic breast cancer - High likelihood of anthracycline resistance due to prior anthracycline exposure in the adjuvant or metastatic setting; Prior anthraquinone (e.g., mitoxantrone) insufficient; Prior cumulative anthracycline dose limited to doxorubicin-equivalent 350 mg/m2 by IV bolus or 450 mg/m2 by prolonged (at least 48 hours) infusion - Measurable or evaluable disease - Brain metastases treated by prior surgery and/or radiotherapy allowed if neurologic status stable 2 weeks after discontinuation of dexamethasone - Hormone receptor status: Not specified --Prior/Concurrent Therapy-- - Biologic therapy: No concurrent prophylactic filgrastim (G-CSF) - Chemotherapy: See Disease Characteristics; At least 3 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosourea) and recovered - Endocrine therapy: See Disease Characteristics - Radiotherapy: See Disease Characteristics; At least 3 weeks since prior radiotherapy and recovered - Surgery: See Disease Characteristics --Patient Characteristics-- - Age: 18 and over - Sex: Male or female - Menopausal status: Not specified - Performance status: Zubrod 0-2 - Life expectancy: At least 12 weeks - Hematopoietic: Absolute granulocyte count greater than 1,500/mm3; Platelet count greater than 100,000/mm3 - Hepatic: Bilirubin no greater than 1.5 mg/dL - Renal: Creatinine no greater than 1.5 mg/dL - Cardiovascular: No history of heart failure; Ejection fraction at least 55% by 2-dimensional echocardiogram - Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception; Other prior malignancy allowed if curatively treated and there is clear diagnosis of metastatic breast cancer requiring treatment
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
MatthewVolm,  Study Chair,  Kaplan Cancer Center

NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York City,  New York,  10016
United States
 


Additional Information:
Study ID Numbers:  CDR0000068486;  NCI-G01-1914,NYU-9851
Study Start Date: September 1998
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00012129

Other Stage 4 Breast Cancer Studies:
1. Combination Chemotherapy in Treating Women With Stage IIIB or Stage IV Breast Cancer

2. Antineoplaston Therapy in Treating Women With Stage IV Breast Cancer

3. Combination Chemotherapy in Treating Patients With Metastatic Breast Cancer

4. Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Women With Metastatic Breast Cancer

5. Methotrexate With or Without Antineoplaston Therapy in Treating Postmenopausal Women With Advanced Refractory Breast Cancer

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