Study of NGR-hTNF in Combination With Doxorubicin in Patients Affected by Advanced or Metastatic Ovarian Cancer

• Status: Completed
• Trial end date: 2016-06-01
• Target enrollment: 0
• Participant gender: 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 2
• Accepts Healthy Volunteers?: No

Details

• 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.