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