Randomized phase II study assessing the combination of Vinflunine with Gemcitabine and Vinflunine with Carboplatin in patients ineligible to cisplatin with advanced or metastatic transitional cell carcinoma of the urothelium. - JASINT 1
- Conditions
- Histologically confirmed diagnosis of locally advanced or metastatic predominantly transitional cell carcinoma of the urothelium (TCCU) [urinary bladder, kidney, renal pelvis, or ureter]MedDRA version: 9.1Level: LLTClassification code 10044412
- Registration Number
- EUCTR2010-020620-22-IT
- Lead Sponsor
- PIERRE FABRE MEDICAMENT
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 68
• Man or woman aged >or=18 years and < 80 years • Signed written informed consent • Histologically confirmed diagnosis of locally advanced or metastatic predominantly transitional cell carcinoma of the urothelium (TCCU) [urinary bladder, kidney, renal pelvis, or ureter] • With the following disease conditions : - Ineligibility for cisplatin-based therapy because of at least one of the following two medical conditions: ? Calculated creatinine clearance (Cockroft-Gault formula) < 60 mL/min ? New York Heart Association Classification Stage II-III Congestive Heart Failure (documented by medical history) • Measurable” disease with at least one uni-dimensional lesion according to RECIST guideline (version 1.1) • ECOG performance status of 0 or 1 • Estimated life expectancy of at least 12 weeks • Patient without prior systemic anticancer therapy unless if it had been administered as neoadjuvant or adjuvant CT for TCCU and if the patient has documented relapse >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 (>or= 2.0 x 109/L); - Haemoglobin >or= 10 g/dL; - Platelet count >or=100,000/mm3; - Serum total bilirubin Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
• ECOG performance status >or= 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 >or= 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 >or=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…)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 end point is to determine the disease control rate as defined by RECIST assessment criteria for both Vinflunine-Gemcitabine and Vinflunine-Carboplatin combinations
- Secondary Outcome Measures
Name Time Method