Ovarian Cancer Metastatic Recurrent
Conditions
Keywords
NGR-hTNF, Ovarian cancer, Doxorubicin
Brief 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.
Detailed description
This is a phase II, open-label,single arm, non-randomized study that will be conducted in patients affected by metastatic ovarian cancer, that will be conducted using Simon's two-stage design method.
Interventions
DRUGNGR-hTNF
NGR-hTNF: 0.8 mcg/m² as 60-minute intravenous infusion every 3 week until confirmed evidence of disease progression or unacceptable toxicity occurs
DRUGdoxorubicin
Doxorubicin: 60mg/m² every 3 weeks, until cumulative dose of 550 mg/m²
Sponsors
AGC Biologics S.p.A.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Antitumor activity defined as response rate | during the study | Evaluated according to Response evaluation criteria in solid tumors (RECIST) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival (PFS) | during the study | PFS evaluated according to Response evaluation criteria in solid tumors (RECIST) |
| Overall survival (OS) | from the date of randomization to the date of death, assessed up to 6 months | Defined as the time from the date of randomization until the date of death due to any cause or the last date the patient was known to be alive |
| CA125 (U/mL) measurement | from the randomization, every 6 weeks until the end of treatment | Tumor marker evaluation |
| Safety according to NCI-CTCAE criteria (version 3) | during the study | To evaluate safety profile related to NGR-hTNF |
Countries
Italy
Outcome results
None listed