Overview
Study of NGR-hTNF in Combination With Doxorubicin in Patients Affected by Advanced or Metastatic Ovarian Cancer
Status:
Completed
Completed
Trial end date:
2016-06-01
2016-06-01
Target enrollment:
0
0
Participant gender:
Female
Female
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.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
AGC Biologics S.p.A.
MolMed S.p.A.Treatments:
Doxorubicin
Liposomal doxorubicin
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.