study of ngr-htnf in combination with doxorubicin in patients affected by advanced or metastatic ovarian cancer

Conditions: Ovarian Cancer Metastatic Recurrent

Summary: the main objective of the trial is to document the response rate in patients affected by metastatic ovarian cancer, treated with ngr-htnf plus doxorubicin. safety will be established by clinical and laboratory assessment according to nci-ctc criteria.

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.

Eligibility criteria:
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.

Keywords: ngr-htnf ovarian cancer doxorubicin