Phase III study comparing vinflunine-gemcitabine and gemcitabine-carboplatin combinations 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)MedDRA version: 18.1Level: LLTClassification code 10046722Term: Urothelial carcinoma bladder stage IVSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2014-005396-82-CZ
- Lead Sponsor
- PIERRE FABRE MEDICAMENT
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 162
- Histologically confirmed diagnosis of locally advanced or metastatic predominantly transitional cell carcinoma of the urothelium (TCC) [urinary bladder, kidney, renal pelvis, or ureter],
- Man or woman aged ³ 18 years and < 80 years,
- Signed written informed consent before completing any study-related procedure,
- Ineligibility for cisplatin-based therapy because of renal impaired function (calculated creatinine clearance by Cockroft-Gault formula < 60 mL/min),
- Presence of a measurable” disease which has not been previously irradiated with at least one uni-dimensional lesion according to RECIST guideline (version 1.1),
- ECOG performance status of 0 or 1 and estimated life expectancy more than 12 weeks
- Patient without prior systemic anticancer therapy for TCC unless cytotoxic agents have been administered in the peri-operative setting (neoadjuvant or adjuvant chemotherapy) and if documented relapse is ³ 6 months after the last dose of chemotherapy,
- Adequate bone marrow and hepatic functions as evidenced by:
o Absolute Neutrophil Count ³ 2.0 x 109/L, Platelet count ³ 100 x 109/L, Haemoglobin ³ 10.0 g/dL
o Serum total bilirubin £ 1.5 x upper limit of normal (ULN), Transaminases £ 2.5x 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 randomization in the trial,
- 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 6 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,
- Patient access to social insurance if applicable in the local regulation.
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 81
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 81
- ECOG performance status ³ 2,
- Calculated creatinine clearance < 30 mL/min (Cockcroft-Gault formula),
- Known brain metastasis or leptomeningeal involvement (computed tomography scans
not required to rule this out unless there is clinical suspicion of central nervous system
disease),
- Peripheral neuropathy Grade = 2 by National Cancer Institute Common Toxicity Criteria
[NCI CTC],
- Prior radiation to = 30% of the bone marrow or completed < 30 days ago or without full
recovery of toxicities,
- Other serious concomitant/uncontrolled medical condition including:
o Infection requiring systemic anti-infective therapy within 2 weeks before
randomization or suspected sepsis
o Any medical condition that might not be controlled such as unstable angina,
myocardial infarction within the previous 6 months, unstable congestive heart
failure (NYHA Stage III-IV) or uncontrolled diabetes,
- Electrocardiogram (ECG) with significant modifications suggesting a high risk of
occurrence of an acute clinical event (such as signs of angina pectoris, high risk
arrhythmia, QT/QTc prolongation),
- Prior systemic immunotherapy for advanced or metastatic urothelium carcinoma,
- Prior systemic neoadjuvant/adjuvant chemotherapy that was completed < 6 months
before documented progression,
- Patient who had received any investigational drug within 30 days before randomisation
- History of another malignancy except adequately treated basal carcinoma of the skin, insitu
cervix carcinoma, localised prostate cancer with limited risk of recurrence (pT = 2b,
Gleason score = 7) that did not lead to any other treatment apart from prostatectomy, or
any other tumor with a disease free interval = 5 years,
- Patients who require treatment with ketoconazole, itraconazole, ritonavir, amprenavir,
indinavir, rifampicine (any potent CYP3A4 inhibitor or inducer), phenytoine or
medicinal products known to prolong QT/QTc interval,
- Known hypersensitivity to the study drugs or to drugs with similar chemical structures,
- Any previous organ allograft or any chronic system disease requiring concurrent immune
therapy,
- 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 6 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.
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