ngr-htnf in combination with an anthracycline in platinum-resistant ovarian cancer (ngr018)

Conditions: Ovarian Cancer

Summary: the primary objective of this extension protocol is to evaluate the early safety of a new schedule of ngr-htnf given weekly, instead of every 3 or 4 weeks, in a cohort of 12 patients randomized to the experimental arm a, as compared to a reference cohort of 12 patients randomized to an anthracycline alone

in this extension protocol ipr/26 of completed ipr/24 study, considering the relatively short half-life of approximately 1 hour and the favourable toxicity profile of ngr-htnf, characterized by transient constitutional symptoms occurring during the first day of administration, an additional cohort of 24 patients will be randomized and the 12 patients enrolled in arm a will receive the same dose of ngr-htnf 0.8 mcg/m2 given as 60 minutes infusion every week. the weekly schedule of ngr-htnf 0.8 mcg/m2 has previously been tested in several studies

Eligibility criteria:
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 and absence of uncontrolled hypertension * 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: 1. surgery and radiation therapy: wash-out period of 14 days 2. 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 or contraindications 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

Keywords: ngr-htnf pegylated liposomal doxorubicin doxorubicin platinum-resistant progression or recurrence ovarian cancer ovarian cancer advanced or metastatic