A Phase II Trial Evaluating Multiple Metastasectomy Combined With Hepatic Artery Infusion Of Floxuridine (FUDR) And Dexamethasone (DXM), Alternating With Systemic Oxaliplatin (OXAL) And Capecitabine (CAPCIT) For Colorectal Carcinoma Metastatic To The Liver
I. Determine the safety and toxicity of hepatic arterial infusion with floxuridine and
dexamethasone followed by systemic therapy with oxaliplatin and capecitabine in patients
with surgically resected liver metastases from primary colorectal carcinoma.
II. Determine the 2-year survival rate of patients treated with this regimen. III. Determine
the 2-year recurrence rate and time to recurrence in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive floxuridine and dexamethasone intra-arterially continuously on days 1-14,
oxaliplatin IV over 2 hours on day 22, and oral capecitabine twice daily on days 22-35.
Treatment repeats every 6 weeks for 4 courses in the absence of disease recurrence or
unacceptable toxicity. After completion of the fourth course, patients receive oxaliplatin
IV over 2 hours on day 1 and oral capecitabine twice daily on days 1-14. Treatment repeats
every 3 weeks for 2 courses in the absence of disease recurrence or unacceptable toxicity.
Patients are followed every 3 months for 1 year and then every 6 months for 2.5 years.
PROJECTED ACCRUAL: A total of 15-75 patients will be accrued for this study within 9
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Toxicity of oxaliplatin as assessed by the National Cancer Institute (NCI) Common Terminology Criteria (CTC) version 2.0
Up to 6 months
North Central Cancer Treatment Group
United States: Food and Drug Administration
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