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Trial record 88 of 164 for:    PEMT

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 : February 7, 2018
Sponsor:
Information provided by (Responsible Party):
Western Regional Medical Center

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
Enrollment 2
Recruitment Details  
Pre-assignment Details  
Arm/Group Title HAI With FOLFOX
Hide Arm/Group Description

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

HAI with FOLFOX: HAI with FOLFOX q 3 weeks

Period Title: Overall Study
Started 2
Completed 0
Not Completed 2
Arm/Group Title HAI With FOLFOX
Hide Arm/Group Description

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

HAI with FOLFOX: HAI with FOLFOX q 3 weeks

Overall Number of Baseline Participants 0
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Number Analyzed 0 participants
<=18 years
Between 18 and 65 years
>=65 years
Sex: Female, Male  
Number Analyzed 0 participants
Female
Male
Region of Enrollment  
Unit of measure:  Participants
United States Number Analyzed 0 participants
1.Primary Outcome
Title 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.
Hide Description 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.
Time Frame One year
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected
Arm/Group Title HAI With FOLFOX
Hide Arm/Group Description:

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

HAI with FOLFOX: HAI with FOLFOX q 3 weeks

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Primary Outcome
Title 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.
Hide Description 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.
Time Frame One year
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected
Arm/Group Title HAI With FOLFOX
Hide Arm/Group Description:

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

HAI with FOLFOX: HAI with FOLFOX q 3 weeks

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Primary Outcome
Title Extra-hepatic Progression (TEP) of HAI With Oxaliplatin/5-FU
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected
Arm/Group Title HAI With FOLFOX
Hide Arm/Group Description:

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

HAI with FOLFOX: HAI with FOLFOX q 3 weeks

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title To Document the Toxicity, Tolerability of the Therapy in This Population.
Hide Description 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).
Time Frame one year
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected
Arm/Group Title HAI With FOLFOX
Hide Arm/Group Description:

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

HAI with FOLFOX: HAI with FOLFOX q 3 weeks

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title HAI With FOLFOX
Hide Arm/Group Description

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

HAI with FOLFOX: HAI with FOLFOX q 3 weeks

All-Cause Mortality
HAI With FOLFOX
Affected / at Risk (%)
Total   0/0 
Show Serious Adverse Events Hide Serious Adverse Events
HAI With FOLFOX
Affected / at Risk (%)
Total   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
HAI With FOLFOX
Affected / at Risk (%)
Total   0/0 
The study has been terminated due to the Investigator no longer employed at the site and has no access to the study
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
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: February 7, 2018