Phase Ib/II study assessing the neo-adjuvant combination therapy of vinflunine with cisplatin followed by radical cystectomy in patients with muscle-invasive bladder cancer - JaNEO

igartis GmbH0 sites42 target enrollmentFebruary 9, 2016

Overview

No summary available.

Registry

who.int

Start Date

February 9, 2016

End Date

TBD

Last Updated

8 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

igartis GmbH

•1\. Male or female patients aged \= 18 years and \= 75 years with legal capacity
•2\. Signed written informed consent
•3\. Histologically confirmed muscle\-invasive urothelial cell carcinoma of the bladder (MIBC) with clinical T2\-T4a (N0/Nx, M0\) assessed by primary PDD\-guided TUR\-B and by the screening magnetic resonance imaging (MRI)
•4\. Confirmed adequate complete resection of all visible tumor during TUR\-B according to current treatment guidelines before registration; the latest TUR\-B must have been done \= 8 weeks before registration
•5\. ECOG performance status of 0 or 1
•6\. Adequate bone marrow, renal and hepatic functions as evidenced by the following:
•Absolute Neutrophil Count \= 2,000 mm3 and \= 7,500 mm3
•Hemoglobin \= 12 g/dL for the safety phase of the study; if the study treatment proved to be adequate tolerated during this safety phase, the threshold can be lowered to \= 10 g/dL according to the decision of the study steering committee
•Platelet count \= 100,000 mm3
•Serum albumin within normal range

•1\. Prior systemic chemotherapy for any kind of malignancy; prior intravesical chemo¬therapy or treatment with BCG is allowed
•2\. Prior radiation of the pelvis or any prior radiation to \>\= 30% of the bone marrow
•3\. Evidence of lymph node (N\+) or distant metastasis (M1\) in the screening MRI assessment, iningcluding known brain metastases or leptomeneal involvement (however, brain\-MRI\-scans are not required to rule out CNS\-involvement, unless there is clinical suspicion of central nervous system (CNS) disease)
•4\. Other malignancies except adequately treated basal carcinoma of the skin, localized prostate cancer Gleason \= 6, in\-situ cervix carcinoma or any other tumor with a disease free interval \= 5 years
•5\. Peripheral neuropathy Grade \= 2 NCI CTCAE v4\.03 or hearing impairment Grade \= 2 NCI CTCAE v.4\.03
•6\. Any concurrent chronic system immune therapy or previous organ allograft
•7\. Weight loss \>5% within the last 3 months before registration
•8\. Any other serious illness or medical condition including:
•Infection requiring systemic anti\-infective therapy within the last 2 weeks before registration
•History of cardio\-vascular disease that might compromise the safe administration of cisplatin