Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 17 of 435 for:    colon cancer AND Capecitabine

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm 1: Capecitabine + Oxaliplatin Arm 2: Floxuridine + Oxaliplatin + Capecitabine
Hide 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
Arm/Group Title Capecitabine + Oxaliplatin Floxuridine + Oxaliplatin + Capecitabine Total
Hide Arm/Group Description Capecitabine + Oxaliplatin Floxuridine + Oxaliplatin + Capecitabine Total of all reporting groups
Overall Number of Baseline Participants 10 12 22
Hide 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
1.Primary Outcome
Title Progression-free Interval (PFI)
Hide Description Time to first recurrence of colon cancer at any site
Time Frame Time from randomization through year 5
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1: Capecitabine + Oxaliplatin Arm 2: Floxuridine + Oxaliplatin + Capecitabine
Hide 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.
Hide 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.
Hide 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
Hide 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
Hide 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
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
Hide Arm/Group Description Capecitabine + Oxaliplatin Floxuridine + Oxaliplatin + Capecitabine
All-Cause Mortality
Capecitabine + Oxaliplatin Floxuridine + Oxaliplatin + Capecitabine
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Capecitabine + Oxaliplatin Floxuridine + Oxaliplatin + Capecitabine
Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/6 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide 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
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
Layout table for Results Point of Contact information
Name/Title: Director, Division of Regulatory Affairs
Organization: NSABP Foundation, Inc.
Phone: 412-330-4600
Layout table for additonal information
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