A Multicenter, Randomized Phase II Trial of Vinflunine/Gemcitabine vs Carboplatin/Gemcitabine as First Line Treatment in Patients With Metastatic Urothelial Carcinoma Unfit for Cisplatin Based Chemotherapy Due to Impaired Renal Function.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
This study aim to compare the efficacy, safety and quality of life of vinflunine/gemcitabine and carboplatin/gemcitabine in patients with metastatic urothelial cancer and impaired renal function.
详细描述
Rational The standard first line treatment for patients with metastatic urothelial carcinoma unfit for cisplatin due to renal impairment is carboplatin containing chemotherapy, with a median overall survival of approximately 8-10 month. New, more effective regimens in terms of tumor control and quality of life are urgently needed. Vinflunine has proven efficacy in urothelial carcinoma and is registered as second line treatment. The combination of gemcitabine and vinflunine has not yet been evaluated in first line treatment for patients with metastatic urothelial carcinoma.
Objectives
- To compare the progression free survival (FPS) of vinflunine/gemcitabine versus carboplatin/gemcitabine in patients with locally advanced or metastatic transitional cell carcinoma of the urothelial tract unfit for cisplatin based chemotherapy due to impaired renal function.
- To evaluate the tumour response (ORR), overall survival (OS) and disease control rate (DCR) of vinflunine/gemcitabine versus carboplatin/gemcitabine
- To assess the safety and toxicity of vinflunine/gemcitabine versus carboplatin/gemcitabine.
- To investigate and compare Quality of life during treatment with vinflunine/gemcitabine and carboplatin/gemcitabine respectively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Vinflunine + gemcitabine
Vinflunine will be given intravenously once every 21 days, starting at a dose of:
- 280 mg/m2 in patients with GFR 40-60 ml/min
- 250 mg/m2 in patients aged >80 years and/or GFR 30-40 ml/min
Gemcitabine will be given intravenously on day 1 and day 8 of every 21 day cycle, starting at a dose of 1000 mg/m2
干预措施: Vinflunine (Drug)
Vinflunine + gemcitabine
Vinflunine will be given intravenously once every 21 days, starting at a dose of:
- 280 mg/m2 in patients with GFR 40-60 ml/min
- 250 mg/m2 in patients aged >80 years and/or GFR 30-40 ml/min
Gemcitabine will be given intravenously on day 1 and day 8 of every 21 day cycle, starting at a dose of 1000 mg/m2
干预措施: Gemcitabine (Drug)
Carboplatin + gemcitabine
Carboplatin will be given intravenously once every 21 days, starting at a dose of AUC 4.5
Gemcitabine will be given intravenously on day 1 and day 8 of every 21 day cycle, starting at a dose of 1000 mg/m2
干预措施: Gemcitabine (Drug)
Carboplatin + gemcitabine
Carboplatin will be given intravenously once every 21 days, starting at a dose of AUC 4.5
Gemcitabine will be given intravenously on day 1 and day 8 of every 21 day cycle, starting at a dose of 1000 mg/m2
干预措施: Carboplatin (Drug)
结局指标
主要结局
Progression-free survival (PFS)
时间窗: From randomization through study completion, on average within 9 months
Defined as the duration from randomization to either confirmed progression (by RECIST) or death from any cause.
次要结局
- Overall response rate (ORR = CR + PR)(From randomization through study completion, on average within 9 months)
- Overall survival (OS)(From randomization to death from any cause, on average within 18 months)
- Disease control rate, DCR (=CR + PR + SD)(From randomization through study completion, on average within 9 months)
- Number of patients with treatment-related adverse events as assessed by CTCAE v4.0(From the date the informed consent is signed up to 30 days after the last dose)
- Quality of Life (QoL) assessed by QLQ-C30(From the date the informed consent is signed up to 30 days after the last dose)
研究者
Dr Anders Ullén
MD, PhD
Karolinska University Hospital