Liposomal Doxorubicin Before Mastectomy in Treating Women With Invasive Breast Cancer
| Status: | Archived |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
A Phase I Study Assessing the Feasibility and Safety of Intraductal Administration of Pegylated Liposomal Doxorubicin (Doxil) in Women With Breast Cancer
RATIONALE: Drugs used in chemotherapy, such as liposomal doxorubicin, work in different ways
to stop the growth of tumor cells, either by killing the cells or by stopping them from
dividing. Giving chemotherapy in different ways, such as into the breast ducts, may kill
more tumor cells. Giving chemotherapy before surgery may make the tumor smaller and reduce
the amount of normal tissue that needs to be removed.
PURPOSE: This phase I trial is studying the side effects and best dose of liposomal
doxorubicin when given before mastectomy in treating women with invasive breast cancer.
OBJECTIVES:
Primary
- Evaluate the feasibility, safety, and maximum tolerated dose of intraductal pegylated
doxorubicin HCl liposome in women with invasive breast cancer awaiting mastectomy.
Secondary
- Determine the pharmacokinetics of intraductal pegylated doxorubicin HCl liposome,
including serial plasma concentrations of doxorubicin and doxorubicinol and tissue
concentrations in different portions of the breast at the time of surgery.
OUTLINE: This is a dose-escalation study.
Patients receive an intraductal injection of pegylated doxorubicin HCl liposome* on day 1.
Patients undergo mastectomy 2-4 weeks later.
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. At
least 6 patients are treated at the MTD.
NOTE: *The first cohort of 3 patients receive intraductal dextrose only followed by surgery
as a feasibility study.
PROJECTED ACCRUAL: A total of 21 patients will be accrued for this study.
We found this trial at
2
sites
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins The name Johns Hopkins has become synonymous...
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