A Multi-Institutional Phase II Trial Of Neoadjuvant Capecitabine (XELODA) And Oxaliplatin (ELOXATIN) For Resectable Colorectal Metastases In The Liver
I. Determine the efficacy and toxicity of neoadjuvant and adjuvant capecitabine and
oxaliplatin in patients with resectable liver metastases secondary to colorectal cancer who
are undergoing surgery.
II. Determine the rates of R0 resection in patients treated with this regimen before
I. Determine the response rate in patients treated with this regimen. II. Determine the
resectability in the subsets of patients defined as resectable preoperatively and treated
with this regimen.
III. Determine improvement in survival associated with downstaging based on metastatic
colorectal prognostic score in patients treated with this regimen.
IV. Determine the disease-free and overall survival of patients treated with this regimen.
V. Correlate drug-specific biomarkers with clinical response in patients treated with this
OUTLINE: This is a multicenter study.
Neoadjuvant chemotherapy: Patients receive oxaliplatin IV over 2 hours on day 1 and oral
capecitabine twice daily on days 1-14. Treatment repeats every 21 days for 4 courses in the
absence of disease progression or unacceptable toxicity.
Surgery: Four to six weeks after the completion of chemotherapy, patients undergo surgical
resection of the tumor.
Adjuvant chemotherapy: Patients with satisfactory response to therapy receive 4 additional
courses of oxaliplatin and capecitabine after surgery.
Patients are followed at 4-6 weeks after surgery, every 3 months for 2 years, every 4 months
for 1 year, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A maximum of 80 patients will be accrued for this study.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Rate of complete resection (R0 resection)
The design of Thall and Simon will be used.
Up to 5 years
M.D. Anderson Cancer Center
United States: Food and Drug Administration
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