Hepatic Artery Infusion With FOLFOX in Liver Metastasis From Breast Cancer
Condition: Metastatic Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: HAI with FOLFOX
Intervention description: HAI with FOLFOX q 3 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Performance status ECOG 0-2 and a life expectancy of >3 months.

          2. Patients were required to have measurable disease in the liver, defined as lesions
             measuring >1 cm in largest diameter on spiral-computed tomography (CT) or magnetic
             resonance imaging (MRI)

          3. Histologically confirmed metastatic advanced solid tumors involving the liver, liver
             replacement less than 70%

          4. No bevacizumab (avastin) use within 4 weeks prior to enrollment.

          5. Absence of portal vein thrombosis

          6. Not a surgical candidate or patients refuge surgery at the time of enrollment

          7. Loss of response to at least 1 line of systemic chemotherapy in metastatic setting

          8. An asymptomatic extra-hepatic disease is allowed, provided that the extent of the
             metastatic disease in the liver represented the bulk of the metastatic disease.

          9. History of liver-directed therapy is eligible at the investigator's discretion.

         10. Adequate renal function with a calculated creatinine clearance greater than 60 mL/min.

         11. Hepatic function as follows: Total Bilirubin ≤3 mg/dL, AST ≤5 times upper normal
             reference value, or ALT ≤ 5 times upper normal reference value.

         12. Adequate bone marrow function (ANC ≥1500 cells/uL; PLT ≥ 100,000 cells/uL) before each
             therapy.

         13. At least three weeks from previous immunotherapy, chemotherapy or radiotherapy before
             being enrolled in this study.

         14. All females in childbearing age MUST have a negative serum HCG test unless patients
             have prior hysterectomy.

        Exclusion Criteria:

          1. Clinical or radiographic evidence of moderate amount of ascites.

          2. History of cirrhosis with Child-Pugh class B or C.

          3. Pregnant or lactating females.

          4. Inability to complete informed consent process and adhere to protocol treatment plan
             and follow-up requirements.

          5. Patients receiving any other investigational agents.

          6. Patients with bleeding diathesis (clinical bleeding, prothrombin time =/> 1.5 X upper
             institutional normal value, INR =/> 1.5, activated partial thromboplastin time aPTT
             =/> 1.5 X upper institutional normal value), active gastric or duodenal ulcer.

          7. History of thrombophilia, recurrent DVTs, diagnosis of phospholipid syndrome.

          8. Past or current history of malignancy other than breast cancer with the exception of
             treated non-melanoma skin cancer or carcinoma in situ of the cervix, or other cancers
             cured by local therapy alone and a DFS ≥5 years.

          9. Concurrent severe illness such as active infection, or psychiatric illness/social
             situations that would limit safety and compliance with study requirements.

         10. Patients with clinically significant cardiovascular disease: myocardial infarction or
             unstable angina within 6 months, New York Heart Association Grade II or greater
             congestive heart failure, serious cardiac arrhythmia requiring medication, unstable
             angina pectoris, clinically significant peripheral vascular disease

         11. Patients have untreated brain metastasis requiring or leptomeningeal metastases.