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

• 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: City of Hope Medical Center
• Information provided by (Responsible Party): City of Hope Medical Center

• Study Type: Interventional
• 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

Participant Flow

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
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

Baseline Characteristics

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
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
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.

Outcome Measures

1. Primary Outcome

Title	Number of Participants With at Least One Dose Limiting Toxicity
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.

Outcome Measure Data

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
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
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.

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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.

Adverse Events

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
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%)
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
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

Limitations and Caveats

[Not Specified]

More Information

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
• 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