NGR-hTNF Administered in Combination With a Standard Oxaliplatin Based Regimen in Patients With Metastatic Colorectal Cancer

Inclusion Criteria:

• Patients ≥ 18 years with metastatic colorectal cancer (CRC) treated with no more than three standard systemic regimens (including biologic agents) for metastatic disease
• Life expectancy more than 3 months
• ECOG Performance status 0-1

• Adequate baseline bone marrow, hepatic and renal function, defined as follows:

  • Neutrophils >1.5 x 10^9/L and platelets > 100 x 10^9/L
  • Bilirubin <1.5 x ULN
  • AST and/or ALT <2.5 x ULN in absence of liver metastasis
  • AST and/or ALT <5 x ULN in presence of liver metastasis
  • Serum creatinine <1.5 x ULN
  • Creatinine clearance (estimated according to Cockcroft-Gault formula) ≥ 50 ml/min

• Patients may have had prior therapy providing the following conditions are met:

  • Chemotherapy, radiation therapy, hormonal therapy or immunotherapy: wash-out period of 28 days before start treatment
  • Surgery: wash-out period of 14 days before start treatment
• Patients must give written informed consent to participate in the study

Exclusion Criteria:

• Concurrent anticancer therapy
• Patients must not receive any other investigational agents while on study
• Patients with myocardial infarction within the last six (6) months, unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, or serious cardiac arrhythmia requiring medication
• Uncontrolled hypertension
• Prolonged QTc interval (congenital or acquired)
• Patient with significant peripheral vascular disease
• Clinical signs of CNS involvement
• Patients with active or uncontrolled systemic disease/infections or with serious illness or medical conditions, which is incompatible with the protocol
• Symptomatic peripheral neuropathy ≥ grade 1 according the NCI CTCAE v.3.0.
• Known hypersensitivity/allergic reaction or contraindications to human albumin preparations or to any of the excipients
• Known hypersensitivity/allergic reaction or contraindications to platinum compounds or fluoropyrimidines
• Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol
• Pregnancy or lactation.
• Patients - both males and females - with reproductive potential (i.e. menopausal for less than 1-year and not surgically sterilized) must practice effective contraceptive measures throughout the study.
• Women of childbearing potential must provide a negative pregnancy test (serum or urine) within 14 days prior to registration