Patients affected by advanced or metastatic ovarian cancer previously treated with platinum regimens (cis or carboplatin) plus paclitaxel MedDRA version: 14.1 Level: PT Classification code 10057529 Term: Ovarian cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Doxorubicin
Concentration unit: mg/ml milligram(s)/millilitre
Concentration number: 2-
Pharmaceutical Form: Solution for infusion
INN o
Sponsors
MOLMED
Eligibility
Sex/Gender
All
Inclusion 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 unidimentionally 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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Antitumor activity defined as response rate according to RECIST criteria;Secondary Objective: ?Progression Free Survival (PFS) ?Overall survival (OS) ?CA125 (U/mL) measurement ?Safety;Primary end point(s): Antitumor activity defined as response rate according to RECIST criteria | — |
Countries
Italy
Outcome results
None listed