Oxaliplatin and Capecitabine With or Without an Hepatic Arterial Infusion With Floxuridine in Treating Patients Who Are Undergoing Surgery and/or Ablation for Liver Metastases Due to Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT00268463

Recruitment Status : Terminated (The study was terminated due to low accrual.)

First Posted : December 22, 2005

Results First Posted : March 15, 2013

Last Update Posted : May 15, 2013

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by (Responsible Party):

NSABP Foundation Inc

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Conditions	Colorectal Cancer Metastatic Cancer
Interventions	Drug: capecitabine Drug: floxuridine Drug: oxaliplatin
Enrollment	22

Participant Flow

Recruitment Details
Pre-assignment Details


Arm/Group Title	Arm 1: Capecitabine + Oxaliplatin	Arm 2: Floxuridine + Oxaliplatin + Capecitabine
Arm/Group Description	Oxaliplatin 130 mg/m2 IV over 2 hou...	Oxaliplatin 130 mg/m2 IV over 2 hou...
Arm/Group Description	Oxaliplatin 130 mg/m2 IV over 2 hours on day 1 every 21 days for 8 cycles: Arm 1 Oral capecitabine 850 mg/m2 twice daily on days 1-14 every 21 days for 8 cycles: Arm 1	Oxaliplatin 130 mg/m2 IV over 2 hours on day 22 every 42 days for 4 cycles and then on day 1 every 21 days for 4 cycles Oral capecitabine 850 mg/m2 twice daily on days 22-35 every 42 days for 4 cycles and then on days 1-14 every 21 days for 4 cycles Continuous hepatic arterial infusion of floxuridine 0.2 mg/kg on days 1-14 every 42 days for 4 cycles
Period Title: Overall Study
Started	10	12
Completed	0	0
Not Completed	10	12
Reason Not Completed
study terminated due to low accrual	10	12

Baseline Characteristics

Arm/Group Title		Capecitabine + Oxaliplatin	Floxuridine + Oxaliplatin + Capecitabine	Total
Arm/Group Description		Capecitabine + Oxaliplatin	Floxuridine + Oxaliplatin + Capecit...	Total of all reporting groups
Arm/Group Description		Capecitabine + Oxaliplatin	Floxuridine + Oxaliplatin + Capecitabine	Total of all reporting groups
Overall Number of Baseline Participants		10	12	22
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	10 participants	12 participants	22 participants
		60 (10.4)	59 (9.4)	59 (9.7)
Sex/Gender, Customized Measure Type: Number Unit of measure: Participants	Number Analyzed	10 participants	12 participants	22 participants
Female		3	4	7
Male		7	7	14
Unknown		0	1	1

Outcome Measures

1.Primary Outcome

Title	Progression-free Interval (PFI)
Description	Time to first recurrence of colon cancer at any site
Description	Time to first recurrence of colon cancer at any site
Time Frame	Time from randomization through year 5

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Arm 1: Capecitabine + Oxaliplatin	Arm 2: Floxuridine + Oxaliplatin + Capecitabine
Arm/Group Description:	Oxaliplatin 130 mg/m2 IV over 2 hou...	Oxaliplatin 130 mg/m2 IV over 2 hou...
Arm/Group Description:	Oxaliplatin 130 mg/m2 IV over 2 hours on day 1 every 21 days for 8 cycles: Arm 1 Oral capecitabine 850 mg/m2 twice daily on days 1-14 every 21 days for 8 cycles: Arm 1	Oxaliplatin 130 mg/m2 IV over 2 hours on day 22 every 42 days for 4 cycles and then on day 1 every 21 days for 4 cycles Oral capecitabine 850 mg/m2 twice daily on days 22-35 every 42 days for 4 cycles and then on days 1-14 every 21 days for 4 cycles Continuous hepatic arterial infusion of floxuridine 0.2 mg/kg on days 1-14 every 42 days for 4 cycles
Overall Number of Participants Analyzed	0	0

No data displayed because Outcome Measure has zero total analyzed.

2.Secondary Outcome

Title	Liver PFI as Measured by Time to Hepatic Progression.
Description	[Not Specified]
Description	[Not Specified]
Time Frame	Time from randomization through year 5

Outcome Measure Data Not Reported

3.Secondary Outcome

Title	Survival as Measured by Time to Death From Any Cause.
Description	[Not Specified]
Description	[Not Specified]
Time Frame	Time from randomization through year 5

Outcome Measure Data Not Reported

4.Secondary Outcome

Title	Scales Specific to Social/Family, Emotional, and Functional Well-being, Perceived Convenience of Care, and Self-reported Symptoms
Description	[Not Specified]
Description	[Not Specified]
Time Frame	Prior to randomization, 4-6 weeks after surgery, 18 weeks after starting chemotherapy and after completion of chemotherapy

Outcome Measure Data Not Reported

5.Secondary Outcome

Title	Quality of Life as Measured by the Functional Assessment of Cancer Therapy Trial Outcome Index at Baseline, at 4-6 Weeks Following Surgery (Before Initiation of Chemotherapy), and Periodically During Study
Description	[Not Specified]
Description	[Not Specified]
Time Frame	Prior to randomization, 4-6 weeks after surgery, 18 weeks after the start of chemotherapy and after completion of chemotherapy

Outcome Measure Data Not Reported

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	Participants at Risk includes any patient who submitted an AE form.

Arm/Group Title	Capecitabine + Oxaliplatin	Floxuridine + Oxaliplatin + Capecitabine
Arm/Group Description	Capecitabine + Oxaliplatin	Floxuridine + Oxaliplatin + Capecit...
Arm/Group Description	Capecitabine + Oxaliplatin	Floxuridine + Oxaliplatin + Capecitabine
All-Cause Mortality
	Capecitabine + Oxaliplatin	Floxuridine + Oxaliplatin + Capecitabine
	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--
Serious Adverse Events Serious Adverse Events
	Capecitabine + Oxaliplatin	Floxuridine + Oxaliplatin + Capecitabine
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/8 (0.00%)	0/6 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Capecitabine + Oxaliplatin	Floxuridine + Oxaliplatin + Capecitabine
	Affected / at Risk (%)	Affected / at Risk (%)
Total	6/8 (75.00%)	3/6 (50.00%)
Eye disorders
Blurred vision ^† 1	1/8 (12.50%)	0/6 (0.00%)
Gastrointestinal disorders
Abdominal pain ^† 1	0/8 (0.00%)	2/6 (33.33%)
Constipation ^† 1	0/8 (0.00%)	1/6 (16.67%)
Dental caries ^† 1	1/8 (12.50%)	0/6 (0.00%)
Diarrhea ^† 1	1/8 (12.50%)	1/6 (16.67%)
Nausea ^† 1	3/8 (37.50%)	1/6 (16.67%)
Vomiting ^† 1	2/8 (25.00%)	2/6 (33.33%)
General disorders
Fatigue ^† 1	0/8 (0.00%)	2/6 (33.33%)
Fever ^† 1	0/8 (0.00%)	1/6 (16.67%)
Hepatobiliary disorders
Bile duct stenosis ^† 1	0/8 (0.00%)	1/6 (16.67%)
Investigations
Alanine aminotransferase increased (ALT/SGPT) ^† 1	0/8 (0.00%)	1/6 (16.67%)
Aspartate aminotransferase increased (AST/SGOT) ^† 1	0/8 (0.00%)	1/6 (16.67%)
Blood bilirubin increased ^† 1	0/8 (0.00%)	1/6 (16.67%)
Neutrophil count decreased ^† 1	2/8 (25.00%)	1/6 (16.67%)
Metabolism and nutrition disorders
Anorexia ^† 1	1/8 (12.50%)	1/6 (16.67%)
Dehydration ^† 1	1/8 (12.50%)	1/6 (16.67%)
Hyperglycemia ^† 1	2/8 (25.00%)	0/6 (0.00%)
Glucose intolerance ^† 1	1/8 (12.50%)	0/6 (0.00%)
Nervous system disorders
Dizziness ^† 1	0/8 (0.00%)	1/6 (16.67%)
Dysgeusia ^† 1	1/8 (12.50%)	1/6 (16.67%)
Peripheral sensory neuropathy ^† 1	3/8 (37.50%)	1/6 (16.67%)
Skin and subcutaneous tissue disorders
Nail loss ^† 1	1/8 (12.50%)	0/6 (0.00%)
Palmar-plantar erythrodysesthesia syndrome ^† 1	1/8 (12.50%)	1/6 (16.67%)
† Indicates events were collected by systematic assessment 1 Term from vocabulary, CTCAE v4.0

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title: Director, Division of Regulatory Affairs

Organization: NSABP Foundation, Inc.

Phone: 412-330-4600

Responsible Party:	NSABP Foundation Inc
ClinicalTrials.gov Identifier:	NCT00268463 History of Changes
Other Study ID Numbers:	NSABP C-09 U10CA012027 ( U.S. NIH Grant/Contract )
First Submitted:	December 20, 2005
First Posted:	December 22, 2005
Results First Submitted:	February 5, 2013
Results First Posted:	March 15, 2013
Last Update Posted:	May 15, 2013

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