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