FOLFOX6 Plus Sir-Spheres Microspheres Plus Avastin in Patients With Nonresectable Liver Metastases From Colorectal Carcinoma

Pilot Study of FOLFOX6 Plus Sir-Spheres® Microspheres (Chemo-radiotherapy) in Combination With Bevacizumab (Avastin) as a First Line Treatment in Patients With Nonresectable Liver Metastases From Primary Colorectal Carcinoma

This pilot study will evaluate the safety and effectiveness of chemo-radiotherapy comprising a regimen of FOLFOX6 chemotherapy plus SIR-Spheres yttrium-90 microspheres (chemo-radiotherapy, also known as "chemo-SIRT"), in combination with the biologic therapy Bevacizumab (Avastin), for the first-line treatment of patients with liver metastases from colorectal carcinoma in whom surgical resection is not feasible.

Inclusion Criteria:

• Histologically confirmed adenocarcinoma of the colon or rectum.
• Unequivocal and measurable CT evidence of liver metastases which are not treatable by surgical resection or local ablation with curative intent.
• ECOG performance status 0 - 1.
• Adequate hematological, renal and hepatic function.

Exclusion Criteria:

• Evidence of ascites, cirrhosis, portal hypertension, main portal vein tumor involvement or thrombosis as determined by clinical or radiologic assessment.
• Any extra-hepatic metastases other than metastases in the lungs and/or bones and/or abdominal or hilar lymph nodes. Central nervous system (CNS) metastases are not allowed.
• Previous radiotherapy delivered to the upper abdomen.
• Peripheral neuropathy > grade 1 (NCI-CTCv3).