Neoadjuvant FOLFOX6 + Cetuximab in Patients With Colorectal Cancer and Unresectable Liver Metastasis

• Status: Completed
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: All

Summary

An innovative therapeutic strategy to increase the complete resection rate is of utmost importance in order to enhance survival in colorectal cancer patients with unresectable liver-only metastasis. Therefore, the investigators propose a prospective study of neoadjuvant chemotherapy using FOLFOX6 plus cetuximab to convert initially unresectable liver metastasis to potentially resectable disease.

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

Details

• Lead Sponsor: Samsung Medical Center
• Treatments: Cetuximab

Criteria

Inclusion Criteria:

• Histologically proven colorectal cancer with metastatic lesion(s) in the liver that is (are) unresectable

• Age ≥ 18

• ECOG performance 0 - 1

• Adequate organ function ((hepatic transaminases ≤ 5x upper limit of normal, bilirubin < 2.0 x upper limit of normal, and creatinine ≤ 1.5x upper limit of normal, platelet > 100,000/ul, absolute neutrophil count ≥ 1,500/ul)

• At least one measurable lesion by RECIST criteria

• Written informed consent

Exclusion Criteria:

• Resectable liver metastasis

• Extrahepatic metastases, regardless of their resectability

• Chronic active hepatitis or cirrhosis

• Prior therapy for metastatic disease

• Pregnant or lactating women

• Uncontrolled medical illnesses including medically uncontrolled infection, uncontrolled hypertension, unstable angina, symptomatic congestive heart failure, myocardial infarction within 6 months

• Previous adjuvant FOLFOX chemotherapy

• Prior adjuvant chemotherapy, if administered within 6 months before study entry

• Known hypersensitivity reaction to any of the components of study treatment

• Prior agents directed against EGFR

• Prior allergic reaction (known sensitivity) to chimerized or murine monoclonal antibody therapy

• Known alcohol or drug abuse

• Participation in another clinical study within the 30 days before registration

• Peripheral neuropathy > grade 1

• Other previous malignancy with exception of a history of a previous curatively treated basal cell carcinoma of the skin of pre-invasive carcinoma of the cervix.