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About
The primary objective of this randomized phase II trial is to compare progression-free survival (PFS) in patients randomized to NGR-hTNF plus an anthracycline versus patients randomized to an anthracycline alone
Full description
Considering the safety/toxicity profile of NGR-hTNF characterized by mild-to-moderate constitutional symptoms, the reversibility of these adverse events generally occurring only during the infusion time; the absence of overlapping toxicities with chemotherapeutic agents; the safety and preliminary antitumor activity observed in previous trial with doxorubicin; and the objective response rate (RR) registered in a phase II trial in previously treated ovarian cancer patients seems justified to evaluate in a randomized phase II trial the efficacy of NGR-hTNF against a doxorubicin-based option in advanced ovarian cancer patients progressing or recurrent after a standard platinum/taxane-based chemotherapy.
Enrollment
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Volunteers
Inclusion criteria
Age ≥ 18 years
Histologically-proven ovarian cancer, fallopian tube and primary peritoneal cancer in advanced or metastatic stage
Patients previously treated with a maximum of two platinum-based regimen plus paclitaxel and with documented progressive disease on treatment (refractory patient population) or within 6 months from last chemotherapy cycle (resistant patient population)
ECOG Performance status 0 - 2
Life expectancy of 12 weeks or more
Normal cardiac function
Adequate baseline bone marrow, hepatic and renal function defined as follows:
At least one (not previously irradiated) target lesion or non-measurable disease only, according to RECIST criteria
Patients may have had prior therapy providing the following conditions are met:
Patients must give written informed consent to participate in the study
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
119 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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