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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
37
NGR-hTNF: 0.8 mcg/m² as 60-minute intravenous infusion every 3 week until confirmed evidence of disease progression or unacceptable toxicity occurs
Doxorubicin: 60mg/m² every 3 weeks, until cumulative dose of 550 mg/m²
Fondazione San Raffaele del Monte Tabor
Milan, Italy
Policlinico Universitario A. Gemelli
Rome, Italy
Antitumor activity defined as response rate
Evaluated according to Response evaluation criteria in solid tumors (RECIST)
Time frame: during the study
Progression Free Survival (PFS)
PFS evaluated according to Response evaluation criteria in solid tumors (RECIST)
Time frame: during the study
Overall survival (OS)
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
Time frame: from the date of randomization to the date of death, assessed up to 6 months
CA125 (U/mL) measurement
Tumor marker evaluation
Time frame: from the randomization, every 6 weeks until the end of treatment
Safety according to NCI-CTCAE criteria (version 3)
To evaluate safety profile related to NGR-hTNF
Time frame: during the study
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