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RATIONALE: Drugs used in chemotherapy, such as doxorubicin hydrochloride liposome and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving more than one drug (combination chemotherapy) together with trastuzumab may be a better way to block tumor growth.
PURPOSE: This phase I/II trial is studying the side effects and best dose of doxorubicin hydrochloride liposome when given together with cyclophosphamide and trastuzumab and to see how well they work in treating patients with stage IV breast cancer.
- Determine the maximum tolerated dose (MTD) of pegylated doxorubicin HCl liposome in combination with cyclophosphamide in patients with stage IV breast cancer. (Phase I)
- Determine the efficacy, in terms of overall clinical response rate, of pegylated doxorubicin HCl liposome at the MTD plus cyclophosphamide and trastuzumab (Herceptin®) (for HER2 neu positive disease) in these patients. (Phase II)
- Assess the treatment-related toxicity associated with each dose level of this regimen. (Phase I)
- Assess overall clinical response rate. (Phase I)
- Assess the safety of this regimen at the MTD in these patients. (Phase II)
- Assess the time to progression and overall survival of patients treated with this regimen. (Phase II)
- Compare the response rate in patients who are heavily pretreated to the response rate in patients who are less heavily pretreated. (Phase II)
OUTLINE: This is a multicenter, non-randomized, phase I, dose-escalation study of pegylated doxorubicin HCl liposome followed by a phase II feasibility study.
- Phase I: Patients receive oral cyclophosphamide once daily on days 1-28 and pegylated doxorubicin HCl liposome IV over 90 minutes on day 1. Treatment repeats every 4-6 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of pegylated doxorubicin HCl liposome until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
- Phase II: Patients receive cyclophosphamide and pegylated doxorubicin HCl liposome as in phase I at the MTD determined in phase I. Some patients with HER2/neu 3+ disease may also receive trastuzumab (Herceptin®) IV over 30-90 minutes weekly or every 3 weeks at the discretion of the treating physician.
After completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 65 patients will be accrued for this study.
Allocation: Non-Randomized, Primary Purpose: Treatment
trastuzumab, cyclophosphamide, pegylated liposomal doxorubicin hydrochloride
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Active, not recruiting
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-08-27T03:44:21-0400
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