Hepatic Artery Infusion With FOLFOX in Liver Metastasis From Breast Cancer

Metastatic Breast Cancer Clinical Trial

Official title:

Pilot Study of Hepatic Arterial Infusion (HAI) With Oxaliplatin, Folinic Acid and 5 Fluorouracil (FOLFOX) in Heavily Pre-Treated Patients With Liver-Predominant Metastasis From Breast Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01937507
• Other study ID #: 12-20
• Status: Terminated
• Phase: Phase 2
• First received: June 24, 2013
• Last updated: January 11, 2018
• Start date: December 2012
• Est. completion date: July 2014

Study information

• Verified date: January 2018
• Source: Western Regional Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

Drug:
• HAI with FOLFOX
HAI with FOLFOX q 3 weeks

Locations

Country	Name	City	State
United States	Western Regional Medical Center Inc	Goodyear	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Western Regional Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	One year
Primary	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.	One year
Primary	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.	One year
Secondary	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).	one year