Phase II Study of NGR-hTNF in Combination With Doxorubicin in Platinum-resistant Ovarian Cancer

Inclusion Criteria: * Age ≥ 18 years * Histologically-proven ovarian cancer, fallopian tube and primary peritoneal cancer in advanced or metastatic stage * Patients previously treated with a maximum of two platinum-based regimen plus paclitaxel and with documented progressive disease on treatment (refractory patient population) or within 6 months from last chemotherapy cycle (resistant patient population) * ECOG Performance status 0 - 2 * Life expectancy of 12 weeks or more * Normal cardiac function * Adequate baseline bone marrow, hepatic and renal function defined as follows: 1. Neutrophils ≥ 1.5 x 109/L; platelets ≥ 100 x 109/L; hemoglobin ≥ 9 g/dL 2. Bilirubin ≤ 1.5 x ULN 3. AST and/or ALT ≤ 2.5 x ULN in absence of liver metastasis or ≤ 5 x ULN in presence of liver metastasis 4. Serum creatinine \< 1.5 x ULN * At least one (not previously irradiated) target lesion or non-measurable disease only, according to RECIST criteria * Patients may have had prior therapy providing the following conditions are met: * Surgery and radiation therapy: wash-out period of 14 days * Systemic anti-tumor therapy: wash-out period of 21 days * Patients must give written informed consent to participate in the study Exclusion Criteria: * Patients must not receive any other investigational agents while on study * More than two previous chemotherapy lines and previous treatment with anthracycline * Patients with myocardial infarction within the last six months, unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, or serious cardiac arrhythmia requiring medication * Prolonged QTc interval (congenital or acquired) \> 450 ms * History or evidence upon physical examination of CNS disease unless adequately treated * 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.