Hepatic Artery Infusion With FOLFOX in Liver Metastasis From Breast Cancer

Stopped early · Phase 2

Conditions studied: Metastatic Breast Cancer

In brief

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.

Key facts

Study ID

NCT01937507

Run by

Western Regional Medical Center

People needed

2

Starts

2012-12-01

Expected to finish

2014-07-01

Last updated by the study team

2018-02-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Performance status ECOG 0-2 and a life expectancy of >3 months.
• 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)
• Histologically confirmed metastatic advanced solid tumors involving the liver, liver replacement less than 70%
• No bevacizumab (avastin) use within 4 weeks prior to enrollment.
• Absence of portal vein thrombosis
• Not a surgical candidate or patients refuge surgery at the time of enrollment
• Loss of response to at least 1 line of systemic chemotherapy in metastatic setting
• 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.
• History of liver-directed therapy is eligible at the investigator's discretion.
• Adequate renal function with a calculated creatinine clearance greater than 60 mL/min.
• Hepatic function as follows: Total Bilirubin ≤3 mg/dL, AST ≤5 times upper normal reference value, or ALT ≤ 5 times upper normal reference value.
• Adequate bone marrow function (ANC ≥1500 cells/uL; PLT ≥ 100,000 cells/uL) before each therapy.
• At least three weeks from previous immunotherapy, chemotherapy or radiotherapy before being enrolled in this study.
• All females in childbearing age MUST have a negative serum HCG test unless patients have prior hysterectomy.

You may not qualify if…

• Clinical or radiographic evidence of moderate amount of ascites.
• History of cirrhosis with Child-Pugh class B or C.
• Pregnant or lactating females.
• Inability to complete informed consent process and adhere to protocol treatment plan and follow-up requirements.
• Patients receiving any other investigational agents.
• 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.
• History of thrombophilia, recurrent DVTs, diagnosis of phospholipid syndrome.
• 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.
• Concurrent severe illness such as active infection, or psychiatric illness/social situations that would limit safety and compliance with study requirements.
• 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
• Patients have untreated brain metastasis requiring or leptomeningeal metastases.

Where it is running

• Western Regional Medical Center Inc — Goodyear, Arizona, United States

Full record on ClinicalTrials.gov

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