Hepatic Artery Infusion With FOLFOX in Liver Metastasis From Breast Cancer

NCT ID: NCT01937507

Last Updated: 2018-02-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2014-07-31

Brief 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.

Detailed Description

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.

Conditions

Metastatic Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HAI with FOLFOX

Hepatic Artery Infusion with Oxaliplatin, 5FU, and Folinic Acid

Group Type: EXPERIMENTAL

HAI with FOLFOX

Intervention Type: DRUG

HAI with FOLFOX q 3 weeks

Interventions

HAI with FOLFOX

HAI with FOLFOX q 3 weeks

Intervention Type: DRUG

Other Intervention Names

Hepatic Artery Infusion

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Western Regional Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jiaxin Niu, MD

Role: PRINCIPAL_INVESTIGATOR

Western Regional Medical Center

Locations

Western Regional Medical Center Inc

Goodyear, Arizona, United States

Countries

United States

Other Identifiers

12-20

Identifier Type: -

Identifier Source: org_study_id