bladder cancer
Conditions
Interventions
* Arm A:
+ Day 1: Vinflunine 280 or 250 mg/m² (20 min IV infusion) + Gemcitabine 1000
or 750 mg/m² (30 min IV infusion)
+ Day 8: Gemcitabine 1000 or 750 mg/m² (30 min IV infusion)
* Arm B:
+ Day
Sponsors
Pierre Fabre
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Man or woman aged > or equal to 18 years and or equal to 6 months after the last dose of CT (prior intravesical CT allowed) - Adequate bone marrow and hepatic functions as evidenced by: + Absolute Neutrophil Count > or equal to 2,000/mm3 (> or equal to 2.0 x 109/L) + Haemoglobin > or equal to 10 g/dL + Platelet count > or equal to 100,000/mm3 + Serum total bilirubin > or equal to 1.5 x upper limit of normal (ULN) + Transaminases
Exclusion criteria
Exclusion criteria: - ECOG performance status > or equal to 2 - Woman if pregnant or lactating or with positive pregnancy test at inclusion; woman of child-bearing potential who did not use or is unwilling or unable to use an acceptable method to avoid pregnancy during the 2 months preceding the start of study treatment, for the entire study period and for up to 3 months after the last dose of study treatment; sexually active fertile man not using effective birth control during the study and up to 6 months after the last dose of study treatment if his partner is a woman of childbearing potential - Known brain metastasis or leptomeningeal involvement. (Computed Tomography (CT)-scans are not required to rule this out unless there is clinical suspicion of central nervous system (CNS) disease) - Peripheral neuropathy Grade > or equal to 2 by NCI CTC [National Cancer Institute Common Terminology Criteria] - Prior radiation to > or equal to 30% of the bone marrow or completed or equal to 5 years - Inadequate renal function defined by a serum creatinine clearance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy Measures: - Will be determined by using RECIST criteria (version 1.1). as follows: assessment of lesions (measurable and non-measurable) at baseline and every 2 cycles. - Progression and tumor response will be evaluated for all randomized patients by the investigators. - Duration of disease control and response will be evaluated for all patients with disease control and responding patients, respectively. - Moreover, clinical parameters as pain intensity will be performed every 2 cycles. · Safety Measures: physical examination and vital signs, performance status, complete blood counts, serum biochemistry, clinical safety, adverse events using the NCI Common Toxicity Criteria (version 2.0). | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the safety profile of the treatment. To evaluate other efficacy parameters: Objective Response Rate (CR + PR rates), duration of response and duration of disease control, Time to treatment failure (TTF), Progression free survival (PFS) and Overall survival (OS). | — |
Countries
Netherlands
Outcome results
None listed