EUCTR2011-000272-34-DE进行中（未招募）不适用
Phase II study assessing the maintenance treatment with vinflunine after first-line therapy with gemcitabine and cisplatin in patients with advanced or metastatic transitional cell carcinoma of the urothelial tract. - JASiMA - JAVLOR Switch in Maintenance
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 77
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1) Patients aged = 18 years
- •2) Histologically confirmed diagnosis of locally advanced or metastatic predominantly transitional cell carcinoma of the urothelium (TCCU) [urinary bladder, kidney, renal pelvis, or ureter]. Not amenable to definitive local/regional therapy.
- •3) Stable Disease, Partial Response or Complete Response as outcome of 1st line treatment with the gemcitabine-cisplatin combination for advanced/metastatic TCCU (confirmed or not).
- •4) Completion of 4 cycles of 1st line treatment with the gemcitabine-cisplatin combination for the chemo-naïve advanced/metastatic TCCU patient and no persistence of any adverse event > Grade 1 related to this treatment.
- •5) Last administration of gemcitabine and cisplatin (i.e. last day of administration of both compounds) = 6 weeks before registration.
- •6) The patient must give written (personally signed and dated) informed consent before completing any study-related procedure which means any assessment or evaluation that would not be part of the routine medical care of the patient.
- •7) Women of childbearing potential must be using a medically accepted method of contraception (i.e. hormonal contraceptives, intrauterine devices) 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 in such a manner that the risk of pregnancy is minimised. Women of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to the start of study treatment.
- •8) Fertile men must be using an effective method of birth control, if their partners are women of childbearing potential, during the study period and up to 3 months after last administration of study medication.
- •9) ECOG performance status of 0 or 1 (patients aged = 80 years with ECOG performance status 1 or ECOG performance status 0 and prior irradiation of the pelvic area are not eligible)
- •10) Estimated life expectancy of at least 3 months
- •11) Adequate haematological, renal and hepatic functions as evidenced by:
- •- Absolute Neutrophil Count = 1,500/mm³ (=1.5 x 10^9/L)
- •- Haemoglobin = 9 g/dL
- •- Platelet count = 100,000/mm³
- •- Serum total bilirubin =1.5 x upper limit of normal (ULN)
- •- Transaminases = 2.5 x ULN [ = 5 times ULN only in case of liver
- •metastasis]
- •- Alkaline phosphatase = 5 x ULN
- •- Calculated creatinine clearance (CrCL) (Cockroft-Gault):
- •= 20 mL/min for age < 75 years
- •= 40 mL/min for age = 75 to < 80 years
- •> 60 mL/min for age = 80 years
- •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 77
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 77
排除标准
- •1) Patients aged < 18 years.
- •2) Patients with predominantly non-TCCU (adenocarcinoma, squamous cell carcinoma or other).
- •3) Prior administration of any systemic anti-tumour therapy (other than Gemcitabine-cisplatin-combination) for treatment of TCCU.
- •4) Progressive Disease during or after 1st line treatment with the gemcitabine cisplatin combination for advanced/metastatic TCCU.
- •5) Known brain metastasis or leptomeningeal involvement (CT Scan/MRI not required to rule this out unless there is clinical suspicion of CNS disease).
- •6) Peripheral neuropathy = Grade 2.
- •7) Any serious, concurrent illness or uncontrolled medical disorder including active infection requiring antibiotics within 2 weeks before registration, uncontrolled cardiac arrhythmia, unstable diabetes mellitus, uncontrolled hypercalcaemia, congestive heart failure, poorly controlled hypertension, unstable angina pectoris, or myocardial infarction within 6 months before registration.
- •8) Screening-electrocardiogram with any significant modifications suggesting a high risk of occurrence of an acute clinical event (such as angina pectoris, high risk arrhythmia, etc.).
- •9) Prior other malignancy. Note: Patients who have had another malignancy and who have been disease-free for at least 3 years or patients with a history of successfully treated basal cell carcinoma of the skin or in-situ cervix carcinoma or localised prostate cancer with limited risk of recurrence (pT = 2b, Gleason score = 7) that was incidentally discovered and did not lead to any other treatment apart from prostatectomy are eligible.
- •10) Known hypersensitivity to vinca alkaloids.
- •11) Prior radiation to = 30% of the bone marrow or radiation not completed at least 28 days before registration or current persistence of any adverse event >Grade 1 related to this treatment.
- •12) Major surgery or trauma within 28 days before registration or presence of any major non-healing wound, fracture or ulcer.
- •13) Prior participation in an interventional clinical study investigating drugs within 30 days before registration, during the treatment period.
- •14) Current treatment with any potent CYP3A4-inhibitor or -inducer
- •15) Pregnant or lactating women or women with positive pregnancy test at screening.
- •16) Any serious and/or unstable pre-existing medical, psychiatric, psychological, familial, sociological, geographical or other condition that could interfere with the patient’s safety, provision of informed consent, or compliance with the study protocol.
- •17) Prisoners or persons who are compulsory detained (involuntary incarcerated).
研究者
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