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A Phase II Study of Continuous Hepatic Arterial Infusion With Floxuridine (FUDR) and Dexamethasone (DEX) in Patients With Unresectable Primary Hepatic Malignancy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00587067
First Posted: January 7, 2008
Last Update Posted: August 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Wake Forest University
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
Results First Submitted: May 9, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Hepatic Cancer
Intervention: Drug: FLOXURIDINE

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Protocol Open to Accrual 6/24/2003, Protocol Closed to Accrual 7/24/2007, Primary Completion Date 5/19/2016, Recruitment location is the medical clinic

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
Floxuridine + Dexamethasone

FLOXURIDINE: [0.16* mg/kg/day X 30 ml] / pump flow rate

* If the patient is >25% above ideal body weight, the dose of FUDR will be calculated from an average of the patients actual and ideal body weights. For example, for a patient who is 5ft. 10 inches and weighs 100kg: Ideal Body Weight (kg) = 50 + (2.3 X height in inches over 5 feet) = 50 + (2.3 X 10) = 73 Weight Used for dose calculation = (100 + 73)/2 = 86.5 Therefore, FUDR Dose will be = (0.16 X 86.5 X 30)/Flow Rate If no dose modification due to toxicity is required, the dosages given above (adjusted for changes in weight and pump flow rate) will be repeated on Day 1 of Week 1 of Cycle 2 and all subsequent cycles.


Participant Flow:   Overall Study
    Floxuridine + Dexamethasone
STARTED   34 
COMPLETED   34 
NOT COMPLETED   0 



  Baseline Characteristics
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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
Floxuridine + Dexamethasone

FLOXURIDINE: [0.16* mg/kg/day X 30 ml] / pump flow rate

* If the patient is >25% above ideal body weight, the dose of FUDR will be calculated from an average of the patients actual and ideal body weights. For example, for a patient who is 5ft. 10 inches and weighs 100kg: Ideal Body Weight (kg) = 50 + (2.3 X height in inches over 5 feet) = 50 + (2.3 X 10) = 73 Weight Used for dose calculation = (100 + 73)/2 = 86.5 Therefore, FUDR Dose will be = (0.16 X 86.5 X 30)/Flow Rate If no dose modification due to toxicity is required, the dosages given above (adjusted for changes in weight and pump flow rate) will be repeated on Day 1 of Week 1 of Cycle 2 and all subsequent cycles.


Baseline Measures
   Floxuridine + Dexamethasone 
Overall Participants Analyzed 
[Units: Participants]
 34 
Age 
[Units: Years]
Mean (Full Range)
 56.5 
 (30 to 85) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      22  64.7% 
Male      12  35.3% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      1   2.9% 
Not Hispanic or Latino      31  91.2% 
Unknown or Not Reported      2   5.9% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      2   5.9% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      0   0.0% 
White      30  88.2% 
More than one race      0   0.0% 
Unknown or Not Reported      2   5.9% 
Region of Enrollment 
[Units: Participants]
 
United States   34 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Treatment Response   [ Time Frame: Up to 5 years ]

2.  Primary:   Number of Patients With Treatment Related Toxicity   [ Time Frame: Up to 5 years ]

3.  Secondary:   Disease Progression   [ Time Frame: Up to 5 years ]

4.  Other Pre-specified:   Molecular Genetic Changes Associated With These Tumors   [ Time Frame: 5 years ]
Results not yet reported.   Anticipated Reporting Date:   06/2020  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
No text entered.


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


Results Point of Contact:  
Name/Title: Dr. William Jarnagin, MD
Organization: Memorial Sloan Kettering Cancer Center
phone: 212-639-3624
e-mail: jarnagiw@mskcc.org



Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00587067     History of Changes
Obsolete Identifiers: NCT00310102
Other Study ID Numbers: 02-120
First Submitted: December 21, 2007
First Posted: January 7, 2008
Results First Submitted: May 9, 2017
Results First Posted: August 4, 2017
Last Update Posted: August 4, 2017