Breast Cancer Clinical Trial
Official title:
Clinical Study to Assess Entry of Chemotherapeutic Agents Into Brain Metastases in Women With Breast Cancer
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor
cells, either by killing the cells or by stopping them from dividing. Lapatinib may stop the
growth of tumor cells by blocking some of the enzymes needed for cell growth. 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. Studying samples of tumor tissue and blood from
patients may help doctors understand how well these drugs can be carried to the brain.
PURPOSE: More definitive knowledge of the penetration of chemotherapeutic and other agents
into the brain is necessary for the future rational design of drug and drug regimens that
target brain metastases. This clinical trial is studying how well capecitabine,
cyclophosphamide, doxorubicin, gemcitabine, lapatinib, paclitaxel, trastuzumab, or
vinorelbine penetrates brain tumors.
OBJECTIVES:
- To determine the concentration of capecitabine, cyclophosphamide, doxorubicin
hydrochloride, gemcitabine hydrochloride, lapatinib ditosylate, paclitaxel, trastuzumab
(Herceptin®), or vinorelbine ditartrate in brain metastases in women with breast
cancer.
- To analyze drug penetrability by modeling the relationship between drug concentration
in the tumor and drug concentration in blood samples.
OUTLINE: Patients are assigned to receive 1 of the 8 agents by the patient's treating
oncologist.
Patients receive a single dose of the following study drugs immediately preceding surgery:
oral capecitabine; cyclophosphamide IV over 30 minutes; doxorubicin hydrochloride IV over 15
minutes; gemcitabine hydrochloride IV over 30 minutes; oral lapatinib ditosylate*;
paclitaxel IV over 3 hours; trastuzumab (Herceptin®) IV over 30-90 minutes; or vinorelbine
ditartrate IV over 10-30 minutes . Patients then undergo craniotomy for resection of the
brain metastases.
NOTE: *Patients receive oral lapatinib ditosylate at least 3 days prior to surgery and
immediately before surgery.
All patients receiving cyclophosphamide, doxorubicin hydrochloride, gemcitabine
hydrochloride, paclitaxel, or vinorelbine ditartrate also receive a single dose of
pegfilgrastim subcutaneously (SC) 24-48 hours after the study drug administration OR
filgrastim (G-CSF) SC once daily for 10 days, beginning 24-48 hours after the study drug
administration.
Blood samples are collected periodically for pharmacological studies. Tissue samples
obtained at surgical resection and blood samples are used to establish cell lines and
analyzed for drug concentration by HPLC, LC-MS/MS or ELISA.
;
Observational Model: Case-Only, Time Perspective: Prospective
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