EUCTR2007-001943-23-ES进行中（未招募）1 期
Randomized Study of LAROTAXEL + Cisplatin (LC) vs. Gemcitabine + Cisplatin (GC) in the First Line Treatment of Locally Advanced/Metastatic Urothelial Tract or Bladder Cancer.------------------------------------------------------------------------------------------------------Estudio aleatorizado de LAROTAXEL + Cisplatino (LC) versus Gemcitabina + Cisplatino (GC) en el tratamiento de primera línea de cáncer del tracto urotelial o vejiga localmente avanzado / metastásico. - CILAB
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 900
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
- •- Patients with histology/cytology confirmed Transitional Cell Carcinoma (TCC) with locally advanced (T4b) or metastatic (lymph node or visceral) urothelial tract or bladder cancer.
- •- ECOG Performans Status < ou = 2.
- •- No prior palliative chemotherapy.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Age < 18 years old.
- •- Disease localized only to the radiation fields without radiologically confirmed progression of the disease within the radiation fields after completion of prior radiotherapy.
- •PRIOR THERAPY:
- •- Time between end of (Neo)adjuvant chemotherapy and relapse < 6 months
- •- Less than 6 weeks or 3 weeks respectively from prior radiotherapy or surgery to time of randomization. Patients pN+ with no residual disease after surgery are not eligible.
- •- Treatment with an investigational agent within 4 weeks (6 weeks for immunotherapy) of study enrollment
- •BIOLOGICAL CRITERIA:
- •- Total Bilirubin > 1.0 x UNL
- •- Creatinine > ou = 1.0 x UNL, or actual creatinine clearance < 60 ml/min if creatinine > 1.0 x UNL and < ou = 1.5 UNL
- •PAST or CURRENT HISTORY
- •- Symptomatic brain metastases or leptomeningeal disease
- •- History of another neoplasm except non metastatic melanoma skin cancer, carcinoma in situ of the cervix, or cancer cured by surgery, small field radiation or chemotherapy < 5 years prior to randomization.
- •- Prior cisplatin as (neo)adjuvant chemotherapy with cumulative dose> 300 mg/m²
- •- Peripheral neuropathy > grade 1
- •- History of inflammatory bowel disease, significant bowel obstruction.
- •- History of hypersensitivity to platinum, gemcitabine, taxanes, polysorbate 80, or to compounds with similar chemical structures.
- •- Any other active illness such as uncontrolled infections, uncontrolled cardiac disease or hypertension, uncontrolled diabetes that would preclude safe administration of study therapy at the time of randomization.
- •CONCOMITANT TREATMENT
- •- Concurrent treatment with strong inhibitors of CYP P450 3A4. For patients who were receiving treatment with such agents, a one-week washout period is required prior to randomization
研究者
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