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

This is a phase II, open-label,single arm, non-randomized study that will be conducted in patients affected by metastatic ovarian cancer, that will be conducted using Simon's two-stage design method.

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.