EUCTR2010-020620-22-DE进行中（未招募）不适用
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
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
- 68
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
- •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
排除标准
- •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…)
研究者
相似试验
进行中（未招募）
不适用
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 1Histologically 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 10044412EUCTR2010-020620-22-ITPIERRE FABRE MEDICAMENT68
撤回
2 期
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 urothelium10004994bladder cancerNL-OMON36397Pierre Fabre5
进行中（未招募）
不适用
phase II study assessing the combination of Vinflunine with Gemcitabine versus Vinflunine with Carboplatin in patients ineligible to cisplatin with advanced or metastatic bladder cancerEUCTR2010-020620-22-BEPIERRE FABRE MEDICAMENT68
进行中（未招募）
不适用
phase II study assessing the combination of Vinflunine with Gemcitabine versus Vinflunine with Carboplatin in patients ineligible to cisplatin with advanced or metastatic bladder cancerThe 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)EUCTR2010-020620-22-ATPIERRE FABRE MEDICAMENT68
进行中（未招募）
1 期
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 urotheliumIt 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 < 60 mL/min.MedDRA version: 13.1Level: LLTClassification code 10046722Term: <Manually entered code. Term in E.1.1>EUCTR2010-020620-22-FRPIERRE FABRE MEDICAMENT68