Neoadjuvant and Adjuvant Capecitabine and Oxaliplatin in Treating Patients With Resectable Liver Metastases Secondary to Colorectal Cancer
Liver Metastases, Recurrent Colon Cancer, Recurrent Rectal Cancer
About this trial
This is an interventional treatment trial for Liver Metastases
Eligibility Criteria
Inclusion Criteria: Histologically confirmed hepatic colorectal metastasis by percutaneous hepatic biopsy Imaging evidence of liver metastasis by CT helical scan Resectable disease, as determined by a surgeon with hepatic surgery expertise (at least 10 resections performed per year) Resectable, defined as a sparing of 2 adjacent liver segments with adequate vascular inflow and outflow and hepatic remnant volume Minor resections (less than a hemihepatectomy) or major resections (hemihepatectomy or extended hepatectomy) allowed Bilobar resection allowed, including atypical resections No evidence of extrahepatic disease by chest x-ray or CT scan of the chest, abdomen, and pelvis Performance status - Zubrod 0-1 WBC at least 3,000/mm^3 Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin at least 9.0 g/dL Bilirubin no greater than 2 mg/dL AST and ALT no greater than 300 IU/L No preexisting chronic hepatic disease (e.g., chronic active hepatitis or cirrhosis) that would preclude surgical resection of metastases Creatinine no greater than 1.5 mg/dL Creatinine clearance 60 mL/min No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No other malignancy within the past 5 years except completely resected nonmelanoma skin cancer or carcinoma in situ of the cervix No preexisting grade 2 or greater peripheral neuropathy No concurrent uncontrolled illness No ongoing or active infection No psychiatric illness or social situation that would preclude study compliance No concurrent biologic therapy No concurrent sargramostim (GM-CSF) More than 6 months since prior adjuvant fluorouracil-based chemotherapy No prior chemotherapy for liver metastasis No prior oxaliplatin for colorectal cancer No prior or concurrent hepatic artery infusion chemotherapy for metastatic disease No prior or concurrent radiotherapy for metastatic disease No prior or concurrent radiofrequency ablation for metastatic disease No prior or concurrent cryotherapy/other ablative techniques for metastatic disease No other concurrent investigational therapy No concurrent oral anticoagulation
Sites / Locations
- University of Texas
Arms of the Study
Arm 1
Experimental
Treatment (oxaliplatin, capecitabine, and surgery)
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.