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

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.

• Colorectal Carcinoma
• Liver Metastases

• Device: SIR-Spheres microspheres
  SIR-Spheres yttrium-90 microspheres
• Drug: FOLFOX6 cycles 1-3
  Oxaliplatin 60 mg/m2, IV infusion, q 2 weeks Leucovorin 200 mg/m2, IV infusion, q 2 weeks 5-Fluorouracil 400 mg/m2, IV bolus, q 2 weeks 5-Fluorouracil 2.4 g/m2, IV infusion, q 2 weeks
  Other Names:

  • Eloxatin
  • Folinic acid
  • 5-FU
• Drug: FOLFOX6 cycles 4 onwards
  Oxaliplatin 85 mg/m2 given, IV infusion, q 2 weeks Leucovorin 200 mg/m2 given, IV infusion, q 2 weeks 5-Fluorouracil 400 mg/m2, IV bolus, q 2 weeks 5-Fluorouracil 2.4 g/m2, IV infusion, q 2 weeks
  Other Names:

  • Eloxatin
  • Folinic acid
  • 5-FU
• Drug: Bevacizumab cycles 3 onwards
  Bevacizumab 10 mg/m2, IV infusion, q 2 weeks commencing with the third cycle of chemotherapy
  Other Name: Avastin

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).