It concerns patients who cannot receive a cisplatin-based regimen as first line chemotherapy for an advanced or metastatic Transitional Cell Carcinoma of the Urothelium (TCCU), in particular those having a creatinine clearance
Conditions
Interventions
Trade Name: Javlor
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: VINFLUNINE
CAS Number: 162652951
Current Sponsor code: L0070
Concentration unit: mg/ml milligram(s)/m
Sponsors
PIERRE FABRE MEDICAMENT
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Man or woman aged > or = 18 years and or = 6 months after the last dose of CT (prior intravesical CT allowed) •Adequate bone marrow and hepatic functions as evidenced by: -Absolute Neutrophil Count = 2,000/mm3 (= 2.0 x 10^9/L) -Haemoglobin = 10 g/dL -Platelet count =100,000/mm3 -Serum total bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: •ECOG performance status = 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 child-bearing 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 = 2 by NCI CTC [National Cancer Institute Common Terminology Criteria] •Prior radiation to =30% of the bone marrow or completed < 30 days ago or without full recovery of toxicities •Other serious illness or medical condition including: -Infection requiring systemic anti-infective therapy -Any medical condition that might not be controlled, for instance patients with unstable angina, patients with myocardial infarction within 6 months or uncontrolled diabetes •Prior systemic chemotherapy for advanced or metastatic disease or neoadjuvant/adjuvant chemotherapy that was completed < 6 months before documented progression •Patient who had received any other investigational drug or anti-cancer therapy within 30 days before randomisation •Other malignancies except adequately treated basal carcinoma of the skin, in-situ cervix carcinoma or any other tumor with a disease free interval =5 years •Inadequate renal function defined by a serum creatinine clearance < 30 mL/min (Cockcroft-Gault formula) •Known hypersensitivity to the study drugs or to drugs with similar chemical structures •Patients who require treatment with ketoconazole, itraconazole, ritonavir, amprenavir, indinavir, rifampicine (any potent CYP3A4 inhibitor or inducer) or phenytoine •Any concurrent chronic system immune therapy or previous organ allograft •Electrocardiogram (ECG) with significant modifications suggesting a high risk of occurrence of an acute clinical event (such as signs of angina pectoris or high risk arrhythmia…)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the disease control rate as defined by RECIST assessment criteria [Complete Response (CR) + Partial Response (PR) + Stable Disease (SD) rates] for both Vinflunine-Gemcitabine and Vinflunine-Carboplatin combinations;Secondary Objective: 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). ;Primary end point(s): The primary endpoint is to determine the disease control rate as defined by RECIST assessment criteria [Complete Response (CR) + Partial Response (PR) + Stable Disease (SD) rates] for both Vinflunine-Gemcitabine and Vinflunine-Carboplatin combinations | — |
Countries
Austria, Belgium, France, Germany, Italy, Spain
Outcome results
None listed