NCT01828736已完成2 期
Multicenter Randomized Phase 2 Trial of Gemcitabine - Platinum With or Without Trastuzumab in Advanced or Metastatic Urothelial Carcinoma With HER2 Overexpression
Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie15 个研究点 分布在 2 个国家目标入组 61 人开始时间: 2004年2月9日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 61
- 试验地点
- 15
- 主要终点
- Progression Free survival
研究概览
简要总结
A multicenter, randomized, Phase 2 trial to study the effectiveness and feasibility of association of trastuzumab with combination chemotherapy in advanced or metastatic bladder cancer patients. Combining monoclonal antibody therapy with combination chemotherapy may improve treatment efficacy on tumours overexpressed HER 2.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Transitional cell carcinoma of the urothelium or bladder histologically proven stage IV AJCC [locally advanced (T4b and / or N + M0) unresectable or metastatic (M1)]
- •Tumor and / or metastasis overexpressing HER2 immunohistochemistry (IHC 3 +) or IHC 2 + and FISH +. Centralized analysis.
- •Measurable disease with at least one lesion with a diameter> 2 cm for conventional methods (clinical examination, CT or MRI) or> 1 cm for the helical scanner. In case of single metastasis, metastatic disease should be histologically proven
- •Age ≥ 18 years and ≤80 years
- •Life expectancy> 3 months,
- •Index performance status <2 according to ECOG PS,
- •No prior chemotherapy other than adjuvant and / or neoadjuvant chemotherapy, without Herceptin ® and complete for more than 6 months (naive to any previous chemotherapy in the metastatic setting)
- •No radiotherapy within 4 weeks prior to inclusion,
- •Normal cardiac function as measured by ejection fraction (LVEF> 50%),
- •Blood and liver satisfactory constants:
- •Hematological criteria: - Neutrophils> 1.5 x 109 / L, - Chips> 100 x 109 / L - Hemoglobin> 10 g / dL, Liver function: - Alkaline phosphatase (unless bone metastases) <2 x N - Total bilirubin <1.5 x N - transaminases (AST, ALT) <1.5 x N, renal Constants: - Creatinine clearance > 30 ml / min (Cockcroft and Gault, cf. Annex XV protocol)
- •Patient's written consent after full information.
排除标准
- •Concurrent treatment with an experimental drug, participation in another clinical trial within <30 days
- •Patients previously treated with Herceptin ®, or another treatment targeting growth factors EGF (eg Iressa ®, Tarceva ®)
- •Existence of a severe pulmonary disease, liver or kidney is likely to be exacerbated by the treatment,
- •Other medical conditions: congestive heart failure or angina pectoris even if medically controlled failure, history of myocardial infarction before entering the trial, hypertension or uncontrolled arrhythmias, significant valvular disease,
- •Patient with dyspnoea at rest or requiring oxygen therapy or with respiratory failure,
- •Presence of a severe infection requiring antibiotics,
- •Presence of CNS metastases or meningeal
- •History of another malignancy uncured or cured for less than 5 years (except basal cell carcinoma, papillary thyroid carcinoma in situ of the cervix treated)
- •Pregnant or lactating or not using effective contraception Women,
- •For Cisplatin only: carrying a serious neurological disease, current events devices> NCI grade 2 neuropathy, hearing loss, creatinine clearance <60 ml / min, the patient can not support a patient hydration.
研究组 & 干预措施
Arm A: Platinum + Gemcitabine
Active Comparator
Gemcitabine = 1 000 mg/m2 Day1 and Day8 given every 21 days IV
- If Creatinin Clearance > 60 ml/min : Cisplatin = Day 1: 70 mg/m² given every 21 days If Creatinin Clearance < 60 ml/min : Carboplatin = Day 1: AUC 5 given every 21 days
干预措施: Gemcitabine (Drug)
Arm A: Platinum + Gemcitabine
Active Comparator
Gemcitabine = 1 000 mg/m2 Day1 and Day8 given every 21 days IV
- If Creatinin Clearance > 60 ml/min : Cisplatin = Day 1: 70 mg/m² given every 21 days If Creatinin Clearance < 60 ml/min : Carboplatin = Day 1: AUC 5 given every 21 days
干预措施: Carboplatin (Drug)
Arm A: Platinum + Gemcitabine
Active Comparator
Gemcitabine = 1 000 mg/m2 Day1 and Day8 given every 21 days IV
- If Creatinin Clearance > 60 ml/min : Cisplatin = Day 1: 70 mg/m² given every 21 days If Creatinin Clearance < 60 ml/min : Carboplatin = Day 1: AUC 5 given every 21 days
干预措施: Cisplatin (Drug)
Arm B: Platinum+Gemcitabine+Trastuzumab
Experimental
Trastuzumab: Charging dose = 8mg/kg on day 1; then 6mg/kg every 21 days given IV + Gemcitabine = 1 000 mg/m2 Day1 and Day8 given every 21 days IV
- If Creatinin Clearance > 60 ml/min : Cisplatin = Day 1: 70 mg/m² given every 21 days If Creatinin Clearance < 60 ml/min : Carboplatin = Day 1: AUC 5 given every 21 days
干预措施: Trastuzumab (Biological)
Arm B: Platinum+Gemcitabine+Trastuzumab
Experimental
Trastuzumab: Charging dose = 8mg/kg on day 1; then 6mg/kg every 21 days given IV + Gemcitabine = 1 000 mg/m2 Day1 and Day8 given every 21 days IV
- If Creatinin Clearance > 60 ml/min : Cisplatin = Day 1: 70 mg/m² given every 21 days If Creatinin Clearance < 60 ml/min : Carboplatin = Day 1: AUC 5 given every 21 days
干预措施: Gemcitabine (Drug)
Arm B: Platinum+Gemcitabine+Trastuzumab
Experimental
Trastuzumab: Charging dose = 8mg/kg on day 1; then 6mg/kg every 21 days given IV + Gemcitabine = 1 000 mg/m2 Day1 and Day8 given every 21 days IV
- If Creatinin Clearance > 60 ml/min : Cisplatin = Day 1: 70 mg/m² given every 21 days If Creatinin Clearance < 60 ml/min : Carboplatin = Day 1: AUC 5 given every 21 days
干预措施: Carboplatin (Drug)
Arm B: Platinum+Gemcitabine+Trastuzumab
Experimental
Trastuzumab: Charging dose = 8mg/kg on day 1; then 6mg/kg every 21 days given IV + Gemcitabine = 1 000 mg/m2 Day1 and Day8 given every 21 days IV
- If Creatinin Clearance > 60 ml/min : Cisplatin = Day 1: 70 mg/m² given every 21 days If Creatinin Clearance < 60 ml/min : Carboplatin = Day 1: AUC 5 given every 21 days
干预措施: Cisplatin (Drug)
结局指标
主要结局
Progression Free survival
时间窗: Participants will be followed from radomization until progression or death, up to 3 years
次要结局
- Number of participants with adverse events as a measure of safety and tolerability(Participants will be followed all along the study period, an expected average of 3 years)
- Overall survival(Participants will be followed from randomization until death or lost of follow-up, up to 3 years)
- Objective response rate(Objective Response Rate will be assessed during treatment period, every 3 cycles, up to 7 months)
- Quality of life(Quality of Life will be assessed during the study period, every 3 cycles (Arm A patients) or every 3 months (Arm B patients), up to 3 years)
研究者
研究点 (15)
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