Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:25 PM
Ignite Modification Date:
2025-12-24 @ 9:25 PM
NCT ID:
NCT00484432
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.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00484432
Study Brief:
Protocol Section:
NCT00484432