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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

June 24, 2013
September 3, 2013
December 2012
December 2013   (final data collection date for primary outcome measure)
• 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 ]
Same as current
Complete list of historical versions of study NCT01937507 on ClinicalTrials.gov Archive Site
• 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).
Same as current
Not Provided
Not Provided
 
Hepatic Artery Infusion With FOLFOX in Liver Metastasis From Breast Cancer
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

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.

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.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Metastatic Breast Cancer
Drug: HAI with FOLFOX
HAI with FOLFOX q 3 weeks
Other Name: Hepatic Artery Infusion
Experimental: HAI with FOLFOX
Hepatic Artery Infusion with Oxaliplatin, 5FU, and Folinic Acid
Intervention: Drug: HAI with FOLFOX
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
14
December 2014
December 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Marci Pierog, RN 623 207-3000 marci.pierog@ctca-hope.com
Contact: India Hill, CCRP 623 207-3000 india.hill@ctca-hope.com
United States
 
NCT01937507
12-20
No
Jiaxin Niu, Western Regional Medical Center
Western Regional Medical Center
Not Provided
Principal Investigator: Jiaxin Niu, MD Western Regional Medical Center
Western Regional Medical Center
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP