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Liver Resection and Floxuridine Plus Fluorouracil and Leucovorin in Treating Patients With Liver Metastases From Colorectal Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00002842
First Posted: January 27, 2003
Last Update Posted: April 11, 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:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
City of Hope Medical Center
Results First Submitted: February 28, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Colorectal Cancer
Metastatic Cancer
Interventions: Drug: floxuridine
Drug: fluorouracil
Drug: leucovorin calcium
Procedure: adjuvant therapy
Procedure: conventional surgery

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Hepatic Resection/Portal Vein FUdr/Systemic 5-FU & Leucovorin

Patients receive floxuridine via portal vein infusion from days 1-14. Systemic chemotherapy consists of leucovorin calcium on days 8-14 and fluorouracil on days 9-13. Courses repeat every 4 weeks for a total of 12 weeks

floxuridine: Starting dose of 0.2 mg/kg/day for 14 consecutive days.

fluorouracil: 300 mg/m2/day by intravenous bolus 24 hours apart for 5 consecutive days.

leucovorin calcium: 500 mg/m2/day by continuous intravenous infusion beginning 24 hours prior to the first dose of 5-FU and continuing until 12 hours following the last dose of 5-FU.

adjuvant therapy: Chemotherapy given after hepatic resection

conventional surgery: Hepatic resection


Participant Flow:   Overall Study
    Hepatic Resection/Portal Vein FUdr/Systemic 5-FU & Leucovorin
STARTED   49 
COMPLETED   22 
NOT COMPLETED   27 
ineligible for surgical resection                27 



  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.
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Reporting Groups
  Description
Hepatic Resection/Portal Vein FUdr/Systemic 5-FU & Leucovorin

Patients receive floxuridine via portal vein infusion from days 1-14. Systemic chemotherapy consists of leucovorin calcium on days 8-14 and fluorouracil on days 9-13. Courses repeat every 4 weeks for a total of 12 weeks

floxuridine: Starting dose of 0.2 mg/kg/day for 14 consecutive days.

fluorouracil: 300 mg/m2/day by intravenous bolus 24 hours apart for 5 consecutive days.

leucovorin calcium: 500 mg/m2/day by continuous intravenous infusion beginning 24 hours prior to the first dose of 5-FU and continuing until 12 hours following the last dose of 5-FU.

adjuvant therapy: Chemotherapy given after hepatic resection

conventional surgery: Hepatic resection


Baseline Measures
   Hepatic Resection/Portal Vein FUdr/Systemic 5-FU & Leucovorin 
Overall Participants Analyzed 
[Units: Participants]
 22 
Age 
[Units: Years]
Median (Full Range)
 56 
 (38 to 77) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      9  40.9% 
Male      13  59.1% 
Region of Enrollment 
[Units: Participants]
 
United States   22 


  Outcome Measures

1.  Primary:   2 Year Disease-free Survival .   [ Time Frame: 2 years after treatment ]


  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
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  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: Jeffrey Longmate, Ph.D.
Organization: City of Hope
phone: 626-256-4673
e-mail: jlongmate@coh.org



Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT00002842     History of Changes
Other Study ID Numbers: 94080
P30CA033572 ( U.S. NIH Grant/Contract )
CHNMC-IRB-94080
NCI-V96-1031
CDR0000065077 ( Registry Identifier: NCI PDQ )
First Submitted: November 1, 1999
First Posted: January 27, 2003
Results First Submitted: February 28, 2017
Results First Posted: April 11, 2017
Last Update Posted: April 11, 2017