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Hepatic Artery Infusion With FOLFOX in Liver Metastasis From Breast Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Western Regional Medical Center
Sponsor:
Information provided by (Responsible Party):
Jiaxin Niu, Western Regional Medical Center
ClinicalTrials.gov Identifier:
NCT01937507
First received: June 24, 2013
Last updated: September 3, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Metastatic Breast Cancer
Drug: HAI with FOLFOX
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Western Regional Medical Center:

Primary Outcome Measures:
  • • To determine response rate (RR), time to intra-hepatic progression (TIP), 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. [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • • To document the toxicity, tolerability of the therapy in this population. [ Time Frame: one year ] [ Designated as safety issue: Yes ]
    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).


Estimated Enrollment: 14
Study Start Date: December 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HAI with FOLFOX
Hepatic Artery Infusion with Oxaliplatin, 5FU, and Folinic Acid
Drug: HAI with FOLFOX
HAI with FOLFOX q 3 weeks
Other Name: Hepatic Artery Infusion

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01937507

Contacts
Contact: Marci Pierog, RN 623 207-3000 marci.pierog@ctca-hope.com
Contact: India Hill, CCRP 623 207-3000 india.hill@ctca-hope.com

Locations
United States, Arizona
Western Regional Medical Center Inc Recruiting
Goodyear, Arizona, United States, 85338
Principal Investigator: Jiaxin Niu, MD         
Sponsors and Collaborators
Western Regional Medical Center
Investigators
Principal Investigator: Jiaxin Niu, MD Western Regional Medical Center
  More Information

No publications provided

Responsible Party: Jiaxin Niu, Medical Oncologist, Western Regional Medical Center
ClinicalTrials.gov Identifier: NCT01937507     History of Changes
Other Study ID Numbers: 12-20
Study First Received: June 24, 2013
Last Updated: September 3, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on October 23, 2014