Neoadjuvant and Adjuvant Capecitabine and Oxaliplatin in Treating Patients With Resectable Liver Metastases Secondary to Colorectal Cancer

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Drugs used in chemotherapy, such as capecitabine and oxaliplatin, use different ways to stop tumor cells from dividing so they stop growing or die. Giving capecitabine and oxaliplatin before surgery may shrink the tumor so that it can be removed. Giving capecitabine and oxaliplatin after surgery may kill any remaining tumor cells. This phase II trial is studying how well capecitabine and oxaliplatin work when given before and after surgery in treating patients with resectable liver metastases that is secondary to colorectal cancer

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Capecitabine; Oxaliplatin

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