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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
Sponsor:
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 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
Hide Arm/Group Description

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
Hide Arm/Group Description

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
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 3 participants 3 participants 10 participants 16 participants
60
(50 to 66)
54
(45 to 77)
53
(35 to 66)
56
(35 to 77)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 10 participants 16 participants
Female
1
  33.3%
2
  66.7%
3
  30.0%
6
  37.5%
Male
2
  66.7%
1
  33.3%
7
  70.0%
10
  62.5%
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%
1
  33.3%
2
  20.0%
3
  18.8%
Hispanic
1
  33.3%
0
   0.0%
2
  20.0%
3
  18.8%
Caucasian
2
  66.7%
2
  66.7%
5
  50.0%
9
  56.3%
Unknown
0
   0.0%
0
   0.0%
1
  10.0%
1
   6.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
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
Number Analyzed 3 participants 3 participants 10 participants 16 participants
90
(80 to 90)
90
(90 to 90)
90
(60 to 100)
90
(60 to 100)
[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.
1.Primary Outcome
Title Number of Participants With at Least One Dose Limiting Toxicity
Hide Description Dose Limiting Toxicity (DLT) defined as any treatment-related grade grade 3 nonhematologic toxicity not reversible to grade 2 or less within 24 hours, or any grade 4 toxicity.Up to three cycles of therapy were allowed with DLTs determined based on first cycle tolerance. Toxicity was graded using the National Cancer Institute Common Toxicity Criteria version 2.0.
Time Frame 4 weeks from start of treatment, up to 2 years.
Hide Outcome Measure Data
Hide Analysis Population Description
All patients receiving treatment were evaluated for DLT.
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
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 3 3 10
Measure Type: Number
Unit of Measure: participants with DLTs
0 0 1
2.Primary Outcome
Title Recommended Phase II Dose
Hide Description The maximum tolerated dose (MTD) of HAI FUdR in combination with intravenous gemcitabine and 90Y-DTPA-cT84.66 is based on toxicities observed during the first cycle and is defined as the highest dose tested in which fewer than 33% of patients experience an attributable DLT to the study drug, when at least 6 patients are treated at that dose and are evaluable for toxicity. Dose escalations proceeded according to a standard 3+3 design.
Time Frame 4 weeks from start of treatment, up to 2 years.
Hide Outcome Measure Data
Hide Analysis Population Description
All patients observed for 56 days while receiving a full course of therapy or who experienced a DLT. Patients withdrawing before completion of the first course, for reasons other than DLT, were replaced.
Arm/Group Title RIT/Gemcitabine/FUdR
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 10
Measure Type: Number
Unit of Measure: mg/kg/day
0.20
3.Secondary Outcome
Title Overall Survival
Hide Description Estimated using the product-limit method of Kaplan and Meier. Event defined as death due to any cause.
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
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
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 3 3 10
Median (95% Confidence Interval)
Unit of Measure: Months
23.2 [1] 
(18.9 to NA)
73.2
(27.4 to 132.9)
41.2
(18.4 to 65.5)
[1]
The upper limit of the 95% confidence interval was not calculable because an insufficient number of participants reached the event at the final time point for assessment.
4.Secondary Outcome
Title Progression-free Survival
Hide Description Estimated using the product-limit method of Kaplan and Meier. Progression is defined as a 25% increase in the sum of products of measurable lesions over the smallest sum observed, or appearance of any lesions that had disappeared, or appearance of any new lesion/site.
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
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
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 3 3 10
Median (95% Confidence Interval)
Unit of Measure: Months
8.3 [1] 
(5.0 to NA)
11.5
(6.6 to 12.9)
9.6
(1.0 to 19.0)
[1]
The upper limit of the 95% confidence interval was not calculable because an insufficient number of participants reached the event at the final time point for assessment.
Time Frame Adverse events were collected over a period of 6 years and 11 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 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
Hide Arm/Group Description

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.

All-Cause Mortality
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
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/3 (66.67%)      3/3 (100.00%)      8/10 (80.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
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
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/3 (0.00%)      1/3 (33.33%)      2/10 (20.00%)    
Gastrointestinal disorders       
Ear, nose and throat examination abnormal * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/10 (10.00%)  1
Mucositis oral * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/10 (10.00%)  1
Oral pain * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/10 (10.00%)  1
General disorders       
Fever * 2  0/3 (0.00%)  0 1/3 (33.33%)  1 0/10 (0.00%)  0
Metabolism and nutrition disorders       
Dehydration * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/10 (10.00%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Treatment related secondary malignancy * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/10 (10.00%)  2
Vascular disorders       
Hypotension * 2  0/3 (0.00%)  0 1/3 (33.33%)  1 0/10 (0.00%)  0
1
Term from vocabulary, meddra10.0
2
Term from vocabulary, meddra9.0
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
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
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/3 (100.00%)      3/3 (100.00%)      10/10 (100.00%)    
Blood and lymphatic system disorders       
Hemoglobin decreased * 1  1/3 (33.33%)  3 2/3 (66.67%)  4 9/10 (90.00%)  16
Cardiac disorders       
Arrhythmia * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/10 (0.00%)  0
Cardiac disorder * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/10 (0.00%)  0
Palpitations * 2  1/3 (33.33%)  1 0/3 (0.00%)  0 0/10 (0.00%)  0
Premature ventricular contractions * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/10 (0.00%)  0
Sinus bradycardia * 1  0/3 (0.00%)  0 2/3 (66.67%)  3 1/10 (10.00%)  1
Sinus tachycardia * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 1/10 (10.00%)  1
Eye disorders       
Vision blurred * 1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/10 (0.00%)  0
Gastrointestinal disorders       
Abdominal distension * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 1/10 (10.00%)  1
Abdominal pain * 1  0/3 (0.00%)  0 3/3 (100.00%)  3 3/10 (30.00%)  4
Anal pain * 2  0/3 (0.00%)  0 0/3 (0.00%)  0 1/10 (10.00%)  1
Constipation * 1  2/3 (66.67%)  3 2/3 (66.67%)  2 3/10 (30.00%)  5
Diarrhea * 1  3/3 (100.00%)  4 2/3 (66.67%)  4 7/10 (70.00%)  11
Dry mouth * 1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/10 (0.00%)  0
Dyspepsia * 1  0/3 (0.00%)  0 1/3 (33.33%)  2 2/10 (20.00%)  3
Ear, nose and throat examination abnormal * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 2/10 (20.00%)  2
Esophageal pain * 2  0/3 (0.00%)  0 0/3 (0.00%)  0 1/10 (10.00%)  1
Gastritis * 2  0/3 (0.00%)  0 0/3 (0.00%)  0 1/10 (10.00%)  1
Gastrointestinal disorder * 2  0/3 (0.00%)  0 0/3 (0.00%)  0 1/10 (10.00%)  1
Mucositis oral * 1  1/3 (33.33%)  1 0/3 (0.00%)  0 2/10 (20.00%)  2
Nausea * 1  3/3 (100.00%)  8 3/3 (100.00%)  4 7/10 (70.00%)  13
Oral hemorrhage * 2  0/3 (0.00%)  0 0/3 (0.00%)  0 1/10 (10.00%)  1
Vomiting * 1  0/3 (0.00%)  0 3/3 (100.00%)  3 4/10 (40.00%)  5
General disorders       
Chest pain * 2  0/3 (0.00%)  0 0/3 (0.00%)  0 1/10 (10.00%)  1
Chills * 1  2/3 (66.67%)  2 2/3 (66.67%)  3 1/10 (10.00%)  1
Disease progression * 2  1/3 (33.33%)  1 0/3 (0.00%)  0 1/10 (10.00%)  1
Edema limbs * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 1/10 (10.00%)  1
Fatigue * 1  3/3 (100.00%)  9 3/3 (100.00%)  11 10/10 (100.00%)  25
Fever * 1  2/3 (66.67%)  3 2/3 (66.67%)  3 2/10 (20.00%)  2
Localized edema * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/10 (0.00%)  0
Pain * 1  2/3 (66.67%)  2 1/3 (33.33%)  2 6/10 (60.00%)  8
Hepatobiliary disorders       
Bile duct stenosis * 2  0/3 (0.00%)  0 0/3 (0.00%)  0 1/10 (10.00%)  1
Hepatic failure * 2  0/3 (0.00%)  0 0/3 (0.00%)  0 1/10 (10.00%)  1
Infections and infestations       
Skin infection * 2  0/3 (0.00%)  0 0/3 (0.00%)  0 1/10 (10.00%)  1
Upper respiratory infection * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 2/10 (20.00%)  2
Urinary tract infection * 1  1/3 (33.33%)  1 1/3 (33.33%)  1 1/10 (10.00%)  1
Injury, poisoning and procedural complications       
Bruising * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 3/10 (30.00%)  3
Vascular access complication * 2  0/3 (0.00%)  0 0/3 (0.00%)  0 1/10 (10.00%)  1
Investigations       
Alanine aminotransferase increased * 1  3/3 (100.00%)  11 3/3 (100.00%)  9 10/10 (100.00%)  21
Alkaline phosphatase increased * 1  2/3 (66.67%)  5 2/3 (66.67%)  4 7/10 (70.00%)  15
Aspartate aminotransferase increased * 1  3/3 (100.00%)  11 3/3 (100.00%)  12 9/10 (90.00%)  22
Bilirubin increased * 2  0/3 (0.00%)  0 0/3 (0.00%)  0 2/10 (20.00%)  2
Creatinine increased * 2  0/3 (0.00%)  0 0/3 (0.00%)  0 1/10 (10.00%)  1
Haptoglobin decreased * 2  0/3 (0.00%)  0 0/3 (0.00%)  0 1/10 (10.00%)  1
Hyperbilirubinemia * 1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/10 (0.00%)  0
Hypercholesterolemia * 1  1/3 (33.33%)  1 3/3 (100.00%)  4 1/10 (10.00%)  1
Leukocyte count decreased * 2  1/3 (33.33%)  2 0/3 (0.00%)  0 9/10 (90.00%)  19
Leukopenia * 1  3/3 (100.00%)  8 3/3 (100.00%)  9 2/10 (20.00%)  2
Lymphocyte count decreased * 2  0/3 (0.00%)  0 0/3 (0.00%)  0 9/10 (90.00%)  13
Lymphopenia * 1  3/3 (100.00%)  5 3/3 (100.00%)  11 1/10 (10.00%)  1
Neutrophil count decreased * 1  2/3 (66.67%)  6 2/3 (66.67%)  6 10/10 (100.00%)  16
Platelet count decreased * 1  2/3 (66.67%)  5 2/3 (66.67%)  8 7/10 (70.00%)  14
Serum cholesterol increased * 2  0/3 (0.00%)  0 0/3 (0.00%)  0 1/10 (10.00%)  2
Weight gain * 1  1/3 (33.33%)  1 3/3 (100.00%)  3 3/10 (30.00%)  6
Weight loss * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/10 (0.00%)  0
Metabolism and nutrition disorders       
Anorexia * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 5/10 (50.00%)  6
Blood bicarbonate decreased * 2  0/3 (0.00%)  0 0/3 (0.00%)  0 1/10 (10.00%)  1
Blood glucose increased * 2  0/3 (0.00%)  0 0/3 (0.00%)  0 5/10 (50.00%)  12
Dehydration * 2  0/3 (0.00%)  0 0/3 (0.00%)  0 2/10 (20.00%)  2
Hypercalcemia * 1  1/3 (33.33%)  2 0/3 (0.00%)  0 0/10 (0.00%)  0
Hyperglycemia * 1  2/3 (66.67%)  3 2/3 (66.67%)  6 0/10 (0.00%)  0
Hypernatremia * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/10 (0.00%)  0
Hypertriglyceridemia * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/10 (0.00%)  0
Hyperuricemia * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/10 (0.00%)  0
Hypoalbuminemia * 1  1/3 (33.33%)  3 2/3 (66.67%)  2 1/10 (10.00%)  1
Hypocalcemia * 1  2/3 (66.67%)  3 1/3 (33.33%)  2 0/10 (0.00%)  0
Hypoglycemia * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 2/10 (20.00%)  2
Hypokalemia * 1  0/3 (0.00%)  0 1/3 (33.33%)  2 0/10 (0.00%)  0
Hypomagnesemia * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/10 (0.00%)  0
Hyponatremia * 1  0/3 (0.00%)  0 1/3 (33.33%)  3 0/10 (0.00%)  0
Hypophosphatemia * 1  2/3 (66.67%)  2 1/3 (33.33%)  1 1/10 (10.00%)  1
Obesity * 1  0/3 (0.00%)  0 1/3 (33.33%)  6 1/10 (10.00%)  4
Serum albumin decreased * 2  0/3 (0.00%)  0 0/3 (0.00%)  0 3/10 (30.00%)  3
Serum calcium increased * 2  1/3 (33.33%)  2 0/3 (0.00%)  0 1/10 (10.00%)  1
Serum glucose decreased * 2  0/3 (0.00%)  0 0/3 (0.00%)  0 1/10 (10.00%)  2
Serum magnesium decreased * 2  0/3 (0.00%)  0 0/3 (0.00%)  0 1/10 (10.00%)  1
Serum potassium decreased * 2  1/3 (33.33%)  1 0/3 (0.00%)  0 2/10 (20.00%)  3
Serum sodium increased * 2  0/3 (0.00%)  0 0/3 (0.00%)  0 1/10 (10.00%)  1
Serum triglycerides increased * 2  0/3 (0.00%)  0 0/3 (0.00%)  0 1/10 (10.00%)  1
Musculoskeletal and connective tissue disorders       
Back pain * 1  0/3 (0.00%)  0 2/3 (66.67%)  3 2/10 (20.00%)  2
Bone pain * 2  0/3 (0.00%)  0 0/3 (0.00%)  0 2/10 (20.00%)  2
Chest wall pain * 2  0/3 (0.00%)  0 0/3 (0.00%)  0 1/10 (10.00%)  1
Joint pain * 1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/10 (0.00%)  0
Myalgia * 1  1/3 (33.33%)  2 0/3 (0.00%)  0 2/10 (20.00%)  2
Pain in extremity * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 1/10 (10.00%)  1
Nervous system disorders       
Dizziness * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 3/10 (30.00%)  3
Headache * 1  1/3 (33.33%)  1 2/3 (66.67%)  2 5/10 (50.00%)  8
Neuralgia * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 1/10 (10.00%)  1
Peripheral sensory neuropathy * 1  2/3 (66.67%)  5 2/3 (66.67%)  4 6/10 (60.00%)  8
Taste alteration * 1  1/3 (33.33%)  1 1/3 (33.33%)  1 1/10 (10.00%)  1
Psychiatric disorders       
Agitation * 1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/10 (0.00%)  0
Anxiety * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 3/10 (30.00%)  3
Depression * 1  1/3 (33.33%)  1 1/3 (33.33%)  1 1/10 (10.00%)  1
Insomnia * 2  0/3 (0.00%)  0 0/3 (0.00%)  0 2/10 (20.00%)  2
Renal and urinary disorders       
Bladder pain * 2  0/3 (0.00%)  0 0/3 (0.00%)  0 1/10 (10.00%)  1
Proteinuria * 1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/10 (0.00%)  0
Renal hemorrhage * 1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/10 (0.00%)  0
Urinary frequency * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 1/10 (10.00%)  1
Urine discoloration * 2  0/3 (0.00%)  0 0/3 (0.00%)  0 2/10 (20.00%)  2
Reproductive system and breast disorders       
Erectile dysfunction * 2  0/3 (0.00%)  0 0/3 (0.00%)  0 1/10 (10.00%)  1
Pelvic pain * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/10 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Allergic rhinitis * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/10 (10.00%)  1
Atelectasis * 2  0/3 (0.00%)  0 0/3 (0.00%)  0 1/10 (10.00%)  1
Cough * 1  0/3 (0.00%)  0 1/3 (33.33%)  2 3/10 (30.00%)  3
Dyspnea * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 1/10 (10.00%)  1
Hiccough * 1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/10 (0.00%)  0
Hypoxia * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/10 (0.00%)  0
Nasal congestion * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 2/10 (20.00%)  2
Pharyngolaryngeal pain * 2  0/3 (0.00%)  0 0/3 (0.00%)  0 1/10 (10.00%)  1
Pleural effusion * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/10 (0.00%)  0
Pneumonitis * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/10 (0.00%)  0
Respiratory disorder * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 2/10 (20.00%)  2
Skin and subcutaneous tissue disorders       
Alopecia * 2  0/3 (0.00%)  0 0/3 (0.00%)  0 2/10 (20.00%)  2
Decubitus ulcer * 1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/10 (0.00%)  0
Hand-and-foot syndrome * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 1/10 (10.00%)  1
Nail disorder * 1  1/3 (33.33%)  1 1/3 (33.33%)  1 0/10 (0.00%)  0
Pain of skin * 1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/10 (0.00%)  0
Pruritus * 2  0/3 (0.00%)  0 0/3 (0.00%)  0 1/10 (10.00%)  1
Rash desquamating * 1  1/3 (33.33%)  1 2/3 (66.67%)  2 4/10 (40.00%)  4
Skin disorder * 1  2/3 (66.67%)  3 0/3 (0.00%)  0 1/10 (10.00%)  1
Sweating * 2  0/3 (0.00%)  0 0/3 (0.00%)  0 3/10 (30.00%)  3
Vascular disorders       
Flushing * 1  1/3 (33.33%)  1 1/3 (33.33%)  1 0/10 (0.00%)  0
Hemorrhage * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/10 (0.00%)  0
Hot flashes * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/10 (0.00%)  0
Hypertension * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 1/10 (10.00%)  3
Hypotension * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 2/10 (20.00%)  3
1
Term from vocabulary, meddra9.0
2
Term from vocabulary, meddra10.0
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Paul Frankel, Ph.D.
Organization: City of Hope
Phone: 626-218-5265
Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT00645710     History of Changes
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