Pre- and Post-operative FOLFOX Based Therapy for Patients With Colorectal Cancer With Liver Involvement

• Status: Terminated
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the effect of short-duration pre-operative FOLFOX based therapy on postoperative problems after liver surgery for patients with metastatic colorectal cancer.

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

Details

• Lead Sponsor: Washington University School of Medicine
• Treatments: Bevacizumab; Cetuximab; Fluorouracil; Leucovorin; Oxaliplatin

Criteria

Inclusion Criteria:

• Synchronous or metachronous colorectal metastases

• Technically resectable liver metastases

• Four or fewer metastases

• No tumors in porta hepatis

• Resection of no more than 70% of liver needed

• Medically suitable candidate for major liver resection

• FDG-PET scan without metastatic disease outside the liver

Exclusion Criteria:

• Near-obstructing or obstructing colon lesions in patients in whom combined resection is planned (as delay for preoperative chemotherapy would be medially impossible)

• Treatment with FOLFOX or cetuximab within 12 months

• Treatment with irinotecan within 12 months

• Abnormal liver function (ALT or AST > 5x ULN, bilirubin > 3x ULN)

• Body mass index >/= 35 kg/m² (as the risk for steatohepatitis is increased)

• Renal insufficiency (Cr > 2.5mg/dL)

• Interstitial lung disease (because cetuximab has been rarely associated with development of interstitial lung disease)

• ECOG performance score >/= 3

• Patients unable to give informed consent

• Pregnant patient (as cetuximab is a Class C drug)

• Peripheral neuropathy >/= grade II (as oxaliplatin causes neuropathy to worsen)