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Hepatic Artery Infusion With FOLFOX in Liver Metastasis From Breast Cancer

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ClinicalTrials.gov Identifier: NCT01937507
Recruitment Status : Terminated (PI Decision)
First Posted : September 9, 2013
Results First Posted : November 8, 2017
Last Update Posted : December 11, 2017
Sponsor:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Metastatic Breast Cancer
Intervention: Drug: HAI with FOLFOX

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
HAI With FOLFOX

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

HAI with FOLFOX: HAI with FOLFOX q 3 weeks


Participant Flow:   Overall Study
    HAI With FOLFOX
STARTED   2 
COMPLETED   0 
NOT COMPLETED   2 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
HAI With FOLFOX

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

HAI with FOLFOX: HAI with FOLFOX q 3 weeks


Baseline Measures
   HAI With FOLFOX 
Overall Participants Analyzed 
[Units: Participants]
 0 


  Outcome Measures

1.  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.   [ Time Frame: One year ]

2.  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.   [ Time Frame: One year ]

3.  Primary:   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.   [ Time Frame: One year ]

4.  Secondary:   To Document the Toxicity, Tolerability of the Therapy in This Population.   [ Time Frame: one year ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The study has been terminated due to the Investigator no longer employed at the site and has no access to the study


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Jessica L. Coats
Organization: CTCA
phone: 6232073899
e-mail: jessica.coats@ctca-hope.com



Responsible Party: Western Regional Medical Center
ClinicalTrials.gov Identifier: NCT01937507     History of Changes
Other Study ID Numbers: 12-20
First Submitted: June 24, 2013
First Posted: September 9, 2013
Results First Submitted: October 10, 2017
Results First Posted: November 8, 2017
Last Update Posted: December 11, 2017