Study of NGR-hTNF in Combination With Doxorubicin in Patients Affected by Advanced or Metastatic Ovarian Cancer

Inclusion Criteria:

* Patients ≥18 years old affected by advanced or metastatic ovarian cancer previously treated with platinum regimens (cis or carboplatin) plus paclitaxel and with documented progression disease within 6 months from last chemotherapy administered (refractory/resistant population) or in progression disease after 6 months from last chemotherapy (platinum regimens plus paclitaxel) administered
* Rechallenge with platinum regimens
* No previous exposure to anthracyclines
* Histologically or cytologically confirmed ovarian carcinoma
* Life expectancy more than 3 months
* ECOG Performance status 0 - 1
* Normal cardiac function (LVEF ≥55%) and absence of uncontrolled hypertension
* Measurable disease defined as ≥1 unidimensional measurable lesion ≥ 20 mm by conventional technics or ≥ 10 mm ( spiral CT scan or PET); ascites is allowed if present with peritoneal carcinosis
* 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
* Patients may have had prior therapy providing the following conditions are met:

  * Chemotherapy and radiotherapy: wash-out period of 28 days
  * Surgery: wash-out period of 14 days
* Absence of any conditions in which hypervolaemia and its consequences (e.g. increased stroke volume, elevated blood pressure) or haemodilution could represent a risk for the patient (take as reference "Technical data sheet human albumin" specifically used in Pharmacy Department for NGR-hTNF dilution)
* 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
* New York Heart Association class II-IV cardiac disease
* Acute angina
* Patients with myocardial infarction within the last six (6) months
* Patient with significant peripheral vascular disease
* Thrombosis of main portal vein
* 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
* Known hypersensitivity/allergic reaction to human albumin preparations or to any of the excipients
* Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol
* Pregnancy or lactation. Patients 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.