Hepatic Artery Infusion With FOLFOX in Liver Metastasis From Breast Cancer

NCT01937507 | Terminated Phase 2 Results

• 1 other identifier: 12-20
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (1)

• To Document the Toxicity, Tolerability of the Therapy in This Population.

  one year

Study Arms (1)

HAI with FOLFOX

EXPERIMENTAL

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

Drug: HAI with FOLFOX

Interventions

HAI with FOLFOX DRUG

HAI with FOLFOX q 3 weeks

Also known as: Hepatic Artery Infusion

HAI with FOLFOX

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Western Regional Medical Center: lead

Study Sites (1)

Western Regional Medical Center Inc

Goodyear, Arizona, 85338, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Folfox protocol

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Limitations and Caveats

The study has been terminated due to the Investigator no longer employed at the site and has no access to the study

Results Point of Contact

• Title: Jessica L. Coats
• Organization: CTCA

jessica.coats@ctca-hope.com

6232073899

Study Officials

• Jiaxin Niu, MD

  Western Regional Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2013
• First Posted: September 9, 2013
• Study Start: December 1, 2012
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: February 7, 2018
• Results First Posted: November 8, 2017

Record last verified: 2018-01

Locations

US (1)