Hepatic Arterial Infusion of Floxuridine, Gemcitabine Hydrochloride, and Radiolabeled Monoclonal Antibody Therapy in Treating Liver Metastases in Patients With Metastatic Colorectal Cancer Previously Treated With Surgery
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ClinicalTrials.gov Identifier: NCT00645710 |
Recruitment Status :
Completed
First Posted : March 28, 2008
Results First Posted : March 28, 2019
Last Update Posted : March 28, 2019
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Study Type | Interventional |
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Study Design | Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Conditions |
Liver Metastases Recurrent Colon Cancer Recurrent Rectal Cancer Stage IV Colon Cancer Stage IV Rectal Cancer |
Interventions |
Drug: gemcitabine hydrochloride Drug: floxuridine Genetic: proteomic profiling Other: matrix-assisted laser desorption/ionization time of flight mass spectrometry Other: liquid chromatography Radiation: yttrium Y 90 anti-CEA monoclonal antibody cT84.66 Other: laboratory biomarker analysis Other: mass spectrometry Other: pharmacological study |
Enrollment | 16 |
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Dose Level 1- FUdR 0.10 mg/kg/Day | Dose Level 2 - FUdR 0.15 mg/kg/Day | Dose Level 3 - FUdR 0.20 mg/kg/Day |
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Patients receive floxuridine as a continuous hepatic arterial infusion on days 1-14 (dose level 0.10 mg/kg/day) and gemcitabine hydrochloride IV (105 mg/m^2) over 30 minutes on days 9 and 11. Patients also receive yttrium Y 90 anti-CEA monoclonal antibody cT84.66 IV (16.6 mCi/m^2) over 25 minutes on day 9. Treatment repeats every 6 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients may receive an additional course of floxuridine in combination with systemic therapy at the discretion of the treating physician. |
Patients receive floxuridine as a continuous hepatic arterial infusion on days 1-14 (dose level 0.15 mg/kg/day) and gemcitabine hydrochloride IV (105 mg/m^2) over 30 minutes on days 9 and 11. Patients also receive yttrium Y 90 anti-CEA monoclonal antibody cT84.66 IV (16.6 mCi/m^2) over 25 minutes on day 9. Treatment repeats every 6 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients may receive an additional course of floxuridine in combination with systemic therapy at the discretion of the treating physician. |
Patients receive floxuridine as a continuous hepatic arterial infusion on days 1-14 (dose level 0.20 mg/kg/day) and gemcitabine hydrochloride IV (105 mg/m^2) over 30 minutes on days 9 and 11. Patients also receive yttrium Y 90 anti-CEA monoclonal antibody cT84.66 IV (16.6 mCi/m^2) over 25 minutes on day 9. Treatment repeats every 6 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients may receive an additional course of floxuridine in combination with systemic therapy at the discretion of the treating physician. |
Period Title: Overall Study | |||
Started | 3 | 3 | 10 |
Completed | 3 | 3 | 10 |
Not Completed | 0 | 0 | 0 |
Arm/Group Title | Dose Level 1 - FUdR 0.10 mg/kg/Day | Dose Level 2 - FUdR 0.15 mg/kg/Day | Dose Level 3 - FUdR 0.20 mg/kg/Day | Total | |
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Patients receive floxuridine as a continuous hepatic arterial infusion on days 1-14 (starting dose level 0.10 mg/kg/day) and gemcitabine hydrochloride IV (105 mg/m^2) over 30 minutes on days 9 and 11. Patients also receive yttrium Y 90 anti-CEA monoclonal antibody cT84.66 IV (16.6 mCi/m^2) over 25 minutes on day 9. Treatment repeats every 6 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients may receive an additional course of floxuridine in combination with systemic therapy at the discretion of the treating physician. |
Patients receive floxuridine as a continuous hepatic arterial infusion on days 1-14 (starting dose level 0.15 mg/kg/day) and gemcitabine hydrochloride IV (105 mg/m^2) over 30 minutes on days 9 and 11. Patients also receive yttrium Y 90 anti-CEA monoclonal antibody cT84.66 IV (16.6 mCi/m^2) over 25 minutes on day 9. Treatment repeats every 6 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients may receive an additional course of floxuridine in combination with systemic therapy at the discretion of the treating physician. |
Patients receive floxuridine as a continuous hepatic arterial infusion on days 1-14 (starting dose level 0.20 mg/kg/day) and gemcitabine hydrochloride IV (105 mg/m^2) over 30 minutes on days 9 and 11. Patients also receive yttrium Y 90 anti-CEA monoclonal antibody cT84.66 IV (16.6 mCi/m^2) over 25 minutes on day 9. Treatment repeats every 6 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients may receive an additional course of floxuridine in combination with systemic therapy at the discretion of the treating physician. |
Total of all reporting groups | |
Overall Number of Baseline Participants | 3 | 3 | 10 | 16 | |
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[Not Specified]
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Age, Continuous
Median (Full Range) Unit of measure: Years |
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Number Analyzed | 3 participants | 3 participants | 10 participants | 16 participants | |
60
(50 to 66)
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54
(45 to 77)
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53
(35 to 66)
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56
(35 to 77)
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 3 participants | 3 participants | 10 participants | 16 participants | |
Female |
1 33.3%
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2 66.7%
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3 30.0%
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6 37.5%
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|
Male |
2 66.7%
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1 33.3%
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7 70.0%
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10 62.5%
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Race/Ethnicity, Customized
Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 3 participants | 3 participants | 10 participants | 16 participants |
Asian |
0 0.0%
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1 33.3%
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2 20.0%
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3 18.8%
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Hispanic |
1 33.3%
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0 0.0%
|
2 20.0%
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3 18.8%
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|
Caucasian |
2 66.7%
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2 66.7%
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5 50.0%
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9 56.3%
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Unknown |
0 0.0%
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0 0.0%
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1 10.0%
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1 6.3%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 3 participants | 3 participants | 10 participants | 16 participants |
3 | 3 | 10 | 16 | ||
Karnofsky Performance Status for Assessment of Functional Impairment
[1] Median (Full Range) Unit of measure: Units on a scale |
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Number Analyzed | 3 participants | 3 participants | 10 participants | 16 participants | |
90
(80 to 90)
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90
(90 to 90)
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90
(60 to 100)
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90
(60 to 100)
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[1]
Measure Description: 100 - Normal no complaints. 90 - Able to carry on normal activity; minor signs or symptoms of disease.80 - Normal activity with effort. 70 - Cares for self; unable to carry on normal activity or active work. 60 - Requires occasional assistance, but is able to care for most personal needs. 50 - Requires considerable assistance and frequent medical care. 40 - Disabled; requires special care and assistance. 30 - Severely disabled; hospitalization indicated although death not imminent. 20 - Very sick. Hospitalization necessary. Active supportive treatment necessary.10 - Moribund. 0 - Dead.
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Name/Title: | Paul Frankel, Ph.D. |
Organization: | City of Hope |
Phone: | 626-218-5265 |
EMail: | pfrankel@coh.org |
Responsible Party: | City of Hope Medical Center |
ClinicalTrials.gov Identifier: | NCT00645710 |
Other Study ID Numbers: |
04122 NCI-2010-01229 CDR0000590335 ( Registry Identifier: PDQ ) |
First Submitted: | March 27, 2008 |
First Posted: | March 28, 2008 |
Results First Submitted: | December 21, 2018 |
Results First Posted: | March 28, 2019 |
Last Update Posted: | March 28, 2019 |