Deliver oxliplatin and 5-FU via HAI to breast cancer patients with liver-only or liver-predominant metastases who have failed at least one line of systemic chemotherapy in metastatic setting.
In this pilot study, the investigators will deliver oxliplatin and 5-FU via HAI to breast cancer patients with liver-only or liver-predominant metastases who have failed at least one line of systemic chemotherapy in metastatic setting. The investigators hypothesize that HAI chemotherapy will be able to convert some patients to surgical resection candidates, or/and to overcome chemo-resistance of liver metastases to systemic i.v. chemotherapy for some clinically fit, heavily pre-treated patients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
2
HAI with FOLFOX q 3 weeks
Western Regional Medical Center Inc
Goodyear, Arizona, United States
Determine Response Rate (RR) of HAI With Oxaliplatin/5-FU Every Three Weeks in Heavily Pre-treated Patients With Advanced Breast Cancer With Metastasis to the Liver.
To determine response rate (RR) of HAI with oxaliplatin/5-FU every three weeks in heavily pre-treated patients with advanced breast cancer with metastasis to the liver.
Time frame: One year
Determine Time to Intra-hepatic Progression (TIP) of HAI With Oxaliplatin/5-FU Every Three Weeks in Heavily Pre-treated Patients With Advanced Breast Cancer With Metastasis to the Liver.
To determine time to intra-hepatic progression (TIP) of HAI with oxaliplatin/5-FU every three weeks in heavily pre-treated patients with advanced breast cancer with metastasis to the liver.
Time frame: One year
Extra-hepatic Progression (TEP) of HAI With Oxaliplatin/5-FU
To determine time to extra-hepatic progression (TEP) of HAI with oxaliplatin/5-FU every three weeks in heavily pre-treated patients with advanced breast cancer with metastasis to the liver.
Time frame: One year
To Document the Toxicity, Tolerability of the Therapy in This Population.
Document the toxicity and tolerability of the therapy using the following CBC with differential, BUN, creatinine, liver function tests,CA 15-3, CA 27.29, Circulating tumor cells (CTCs)and Restaging radiographic studies (MRI or CT liver protocol).
Time frame: one year
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