phase II study assessing the combination of Vinflunine with Gemcitabine versus Vinflunine with Carboplatin in patients ineligible to cisplatin with advanced or metastatic bladder cancer
- Conditions
- The trial concerns patients suffering from advanced or metastatic Transitional Cell Carcinoma of the Urothelium (TCCU) who are unfit for Cisplatin-containing first-line treatment due to reduced renal function (GFR 30-60 mL/min) or due to reduced cardiac function (NYHA II-III)MedDRA version: 14.1Level: LLTClassification code 10046722Term: Urothelial carcinoma bladder stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2010-020620-22-BE
- 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 = 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 = 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 = 1.5 x upper limit of normal (ULN)
- Transaminases = 2.5 x ULN [= 5 x ULN only in case of liver metastasis]
• Absence of psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; these conditions should be assessed with the patient before registration in the trial
• Patient access to social insurance if applicable in the local regulations
• Women of childbearing potential must be using a medically accepted method of contraception to avoid pregnancy during the 2 months preceding the start of study treatment, throughout the study period and for up to 3 months after the last dose of study treatment; women of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to the start of study treatment
• Fertile men must be using an effective method of birth control during the study and up to 6 months after the last dose of study treatment if their partners are women of childbearing potential
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 68
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 68
• 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, localised prostate cancer with limited risk of recurrence (pT < or = 2b, Gleason score < or =7) that was incidentally discovered and did not lead to any other treatment apart from prostatectomy, 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…)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method