Efficacy of Neoadjuvant XELOX/AVASTIN Therapy for Nonresectable Colorectal Liver Metastases With Secondary Hepatic Resection/Radiofrequency
- Evaluate the conversion rate of nonresectable disease to resectable disease in patients
with nonresectable liver metastases secondary to colorectal adenocarcinoma treated with
neoadjuvant therapy comprising oxaliplatin, capecitabine, and bevacizumab followed by
hepatic resection and/or radiofrequency ablation.
- Evaluate progression-free survival of patients treated with this regimen.
- Determine disease-free and overall survival of patients treated with this regimen.
- Determine the toxicities of this regimen in these patients.
- Neoadjuvant therapy: Patients receive oxaliplatin IV over 2 hours and bevacizumab IV
over 1 hour on day 1 and oral capecitabine twice daily on days 1-14. Treatment repeats
every 3 weeks for 4-6 courses in the absence of disease progression or unacceptable
toxicity or until conversion to resectable disease.
- Surgery and/or radiofrequency ablation (RFA): Patients undergo hepatic resection (with
or without RFA) when tumor is deemed resectable. Patients with stable (< 8 lesions) and
unresectable disease undergo laparoscopic or percutaneous RFA. RFA repeats once 4-6
- Adjuvant therapy: Beginning 6-8 weeks after surgery and/or RFA, patients may receive
adjuvant therapy comprising oxaliplatin, capecitabine, and bevacizumab, as in
neoadjuvant therapy, for up to 4 courses.
After completion of study treatment, patients are followed every 4 months.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
Masking: Open Label, Primary Purpose: Treatment
Conversion rate of nonresectable disease to resectable disease
Vijay Khatri, MD, FACS
University of California, Davis
|University of California Davis Cancer Center||Sacramento, California 95817|