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

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ClinicalTrials.gov Identifier: NCT00002842
Recruitment Status : Completed
First Posted : January 27, 2003
Results First Posted : April 11, 2017
Last Update Posted : April 11, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
City of Hope Medical Center

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
Enrollment 49
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Hepatic Resection/Portal Vein FUdr/Systemic 5-FU & Leucovorin
Hide Arm/Group Description

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

Period Title: Overall Study
Started 49
Completed 22
Not Completed 27
Reason Not Completed
ineligible for surgical resection             27
Arm/Group Title Hepatic Resection/Portal Vein FUdr/Systemic 5-FU & Leucovorin
Hide Arm/Group Description

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

Overall Number of Baseline Participants 22
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 22 participants
56
(38 to 77)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants
Female
9
  40.9%
Male
13
  59.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 22 participants
22
1.Primary Outcome
Title 2 Year Disease-free Survival .
Hide Description Estimated using the product-limit method of Kaplan and Meier. Disease free survival, defined as first documented evidence of treatment failure. Acceptable evidence includes: Anastomotic - positive cytology or biopsy; Abdominal, pelvic and retroperitoneal nodes - progressively enlarging node as evidenced by 2 CT scans separated by at least a 4 week interval, ureteral obstruction in the presence of a mass as documented on CT scan; Peritoneum - positive cytology or biopsy, progressively enlarged intraperitoneal solid mass as evidenced by 2 CT scans separated by at least 4 weeks; Ascites - positive cytology or biopsy; Liver - positive cytology or biopsy; Pelvic mass - positive cytology or biopsy, progressively enlarging intrapelvic solid mass as evidenced by 2 CT scans separated by at least 4 weeks; Abdominal wall - positive cytology or biopsy; Lung - positive cytology or biopsy or presence of multiple pulmonary nodules; Bone marrow - positive cytology, aspiration or biopsy.
Time Frame 2 years after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Hepatic Resection/Portal Vein FUdr/Systemic 5-FU & Leucovorin
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 22
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
9
(2 to 34)
Time Frame Adverse events occurring over a period of 7 years and 6 months.
Adverse Event Reporting Description "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
 
Arm/Group Title Hepatic Resection/Portal Vein FUdr/Systemic 5-FU & Leucovorin
Hide Arm/Group Description

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

All-Cause Mortality
Hepatic Resection/Portal Vein FUdr/Systemic 5-FU & Leucovorin
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Hepatic Resection/Portal Vein FUdr/Systemic 5-FU & Leucovorin
Affected / at Risk (%) # Events
Total   8/22 (36.36%)    
Gastrointestinal disorders   
Diarrhea * 1  2/22 (9.09%)  2
Investigations   
AGC * 2  2/22 (9.09%)  2
Activated partial thromboplastin time prolonged * 1  1/22 (4.55%)  1
Lymphopenia * 1  1/22 (4.55%)  1
Neutrophil count decreased * 1  2/22 (9.09%)  2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Treatment related secondary malignancy * 1  1/22 (4.55%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, meddra9.0
2
Term from vocabulary, COH
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Hepatic Resection/Portal Vein FUdr/Systemic 5-FU & Leucovorin
Affected / at Risk (%) # Events
Total   22/22 (100.00%)    
Blood and lymphatic system disorders   
Hemoglobin decreased * 2  11/22 (50.00%)  26
Cardiac disorders   
Dysrhythmias * 1  2/22 (9.09%)  3
Pericardial * 1  1/22 (4.55%)  1
Arrhythmia supraventricular * 2  1/22 (4.55%)  1
Sinus bradycardia * 2  1/22 (4.55%)  1
Gastrointestinal disorders   
Abdominal pain * 2  5/22 (22.73%)  8
Ascites * 2  1/22 (4.55%)  1
Colitis * 2  1/22 (4.55%)  1
Constipation * 2  4/22 (18.18%)  4
Diarrhea * 2  20/22 (90.91%)  66
Gastrointestinal disorder * 2  2/22 (9.09%)  2
Mucositis oral * 2  7/22 (31.82%)  10
Nausea * 2  15/22 (68.18%)  31
Not Available * 2  3/22 (13.64%)  6
Proctitis * 2  1/22 (4.55%)  1
Rectal pain * 2  1/22 (4.55%)  1
Vomiting * 2  12/22 (54.55%)  19
General disorders   
Other Misc * 1  9/22 (40.91%)  14
Stomatitis * 1  7/22 (31.82%)  10
Chills * 2  1/22 (4.55%)  1
Fatigue * 2  12/22 (54.55%)  20
Fever * 2  3/22 (13.64%)  3
Fever (no infection) * 1  7/22 (31.82%)  15
Oedema NOS * 2  2/22 (9.09%)  7
Pain * 2  2/22 (9.09%)  5
Infections and infestations   
Catheter related infection * 2  1/22 (4.55%)  1
Infection * 2  2/22 (9.09%)  2
Injury, poisoning and procedural complications   
Bruising * 2  1/22 (4.55%)  1
Investigations   
AGC * 1  5/22 (22.73%)  14
Alanine aminotransferase increased * 2  11/22 (50.00%)  41
Alkaline Phosphatase * 1  5/22 (22.73%)  18
Alkaline phosphatase increased * 2  8/22 (36.36%)  26
Aspartate aminotransferase increased * 2  12/22 (54.55%)  32
Bilirubin * 1  1/22 (4.55%)  1
Creatinine * 1  1/22 (4.55%)  2
Creatinine increased * 2  1/22 (4.55%)  3
HGB/HCT * 1  8/22 (36.36%)  32
Hyperbilirubinemia * 2  2/22 (9.09%)  9
INR increased * 2  5/22 (22.73%)  8
Leukopenia * 2  10/22 (45.45%)  21
Lymphopenia * 2  1/22 (4.55%)  3
Neutrophil count decreased * 2  4/22 (18.18%)  7
Platelet count decreased * 2  6/22 (27.27%)  12
Platelets * 1  4/22 (18.18%)  17
Prothrombin Time * 1  4/22 (18.18%)  6
SGOT/SGT * 1  9/22 (40.91%)  39
WBC * 1  7/22 (31.82%)  19
Weight gain * 2  1/22 (4.55%)  1
Weight loss * 2  3/22 (13.64%)  5
Metabolism and nutrition disorders   
Weight (Food Intake) * 1  1/22 (4.55%)  2
Anorexia * 2  7/22 (31.82%)  8
Dehydration * 2  6/22 (27.27%)  6
Hypercalcemia * 2  1/22 (4.55%)  1
Hyperglycemia * 2  10/22 (45.45%)  31
Hypoalbuminemia * 2  8/22 (36.36%)  25
Hypocalcemia * 2  11/22 (50.00%)  29
Hypoglycemia * 2  2/22 (9.09%)  2
Hypokalemia * 2  3/22 (13.64%)  6
Hypomagnesemia * 2  3/22 (13.64%)  4
Hyponatremia * 2  3/22 (13.64%)  3
Musculoskeletal and connective tissue disorders   
Muscle weakness * 2  1/22 (4.55%)  1
Nervous system disorders   
Cortical/State of Consciousness * 1  1/22 (4.55%)  1
Depressed level of consciousness * 2  1/22 (4.55%)  1
Dizziness * 2  3/22 (13.64%)  3
Headache * 1  2/22 (9.09%)  4
Motor Activity * 1  1/22 (4.55%)  1
Peripheral Nervous System Sensory * 1  1/22 (4.55%)  1
Peripheral motor neuropathy * 2  5/22 (22.73%)  7
Taste alteration * 2  1/22 (4.55%)  1
Psychiatric disorders   
Anxiety * 2  4/22 (18.18%)  7
Depression * 2  1/22 (4.55%)  1
Insomnia * 2  1/22 (4.55%)  1
Mood * 1  1/22 (4.55%)  1
Respiratory, thoracic and mediastinal disorders   
Respiratory disorder * 2  2/22 (9.09%)  2
Skin and subcutaneous tissue disorders   
Alopecia * 1  3/22 (13.64%)  6
Extensive Skin Rash * 1  1/22 (4.55%)  1
Hand-and-foot syndrome * 2  1/22 (4.55%)  1
Local Skin Rash * 1  3/22 (13.64%)  4
Nail disorder * 2  1/22 (4.55%)  1
Rash desquamating * 2  9/22 (40.91%)  12
Sweating * 2  1/22 (4.55%)  2
Vascular disorders   
Hypertension * 1  1/22 (4.55%)  1
Hypotension * 2  4/22 (18.18%)  6
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, COH
2
Term from vocabulary, meddra9.0
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jeffrey Longmate, Ph.D.
Organization: City of Hope
Phone: 626-256-4673
EMail: jlongmate@coh.org
Layout table for additonal information
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