NCT02818725已完成3 期
Intensified Methotrexate, Vinblastine, Doxorubicin and Cisplatin +/-Panitumumab as First-line Treatment of Advanced Urothelial Carcinoma in Patients Without Harvey Nor Kirsten Rat Sarcoma Viral Oncogene Homolog Mutations. Phase II Study
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- UNICANCER
- 入组人数
- 133
- 试验地点
- 17
- 主要终点
- Time to progression
研究概览
简要总结
OBJECTIVES OF THE TRIAL
Primary objective
Evaluation of efficacy in terms of progression-free survival at 9 months of the combination of intensified methotrexate, vinblastine, doxorubicin and cisplatin with or without panitumumab as first-line treatment of advanced urothelial carcinoma in patients without Harvey nor Kirsten rat sarcoma viral oncogene homolog mutations.
Secondary objectives
- To assess toxicity
- To assess response rate
- To assess overall survival
- To assess time to progression
- To study the correlation between response rate, time to progression, overall survival and biological parameters
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
- •Primary tumour of the bladder or upper urinary tract
- •Histologically confirmed infiltrating urothelial carcinoma (epidermoid and/or glandular forms are accepted)
- •Patients without Harvey and Kirsten-rat sarcoma viral oncogene homolog mutations
- •Advanced disease defined by a locally advanced stage (T4 and/or N+) ineligible for surgical resection, or a metastatic stage (M1)
- •Patients with at least 1 evaluable lesion as per Response evaluation criteria in solid tumors version 1.1 (RECIST v1.1)
- •18 ≤ age ≤ 75 years
- •General condition 0 or 1 as per the WHO scale
- •Absence of previous chemotherapy for advanced disease (chemotherapy with gemcitabine and platinum salt delivered as an adjuvant is accepted if this ended more than a year ago)
- •Haematological function: Haemoglobin >11 g/dl, neutrophils ≥1500/mm³, platelets ≥100,000/mm³
- •Liver function: Grade* 0 Aspartate aminotransferase and Alanine aminotransferase (< grade* 3 for liver metastases), grade* 0 alkaline phosphatases, normal bilirubin
- •Renal function: calculated (or measured) creatinine clearance >60 ml/min
- •Patients covered by a social security scheme
- •Patient having read the information sheet and signed the informed consent form.
排除标准
- •Pure adenocarcinoma or pure epidermoid carcinoma or mixed or pure small-cell neuroendocrine carcinoma
- •Previous treatment with one of the following molecules: methotrexate, vinblastine, doxorubicin or Epidermal Growth Factor inhibitor
- •History of interstitial pneumonitis or pulmonary fibrosis
- •History of cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, uncontrolled serious cardiac arrhythmia) in the year prior to randomisation (≤1 year)
- •Ventricular ejection fraction <50%
- •Blood calcium and/or magnesium ≥ grade* 1
- •History of cancer in the 5 years prior to entry in the trial other than basal cell skin cancer or in situ epithelioma of the cervix,
- •Treatment with radiotherapy for analgesic purposes (unless treatment was discontinued at least 15 days prior to inclusion in the trial)
- •Potential allergy to panitumumab
- •Male or female patients not agreeing to use an effective method of contraception throughout the duration of treatment and for 6 months after treatment discontinuation
- •Pregnant women, or female subjects liable to become pregnant or currently breast-feeding,
- •Patient already included in another therapeutic trial on an investigational medicinal product,
- •Persons deprived of their freedom or under judicial protection (including guardianship),
- •Unable to receive medical follow-up during the trial owing to geographical, social or psychological reasons.
研究组 & 干预措施
Chemotherapy
Active Comparator
Intensified- Methotrexate Vinblastin Doxorubicin Cisplatin
干预措施: Chemotherapy (Drug)
Arm B: chemotherapy + panitumumab
Experimental
Intensified- Methotrexate Vinblastin Doxorubicin Cisplatin +/- panitumumab
干预措施: Chemotherapy (Drug)
Arm B: chemotherapy + panitumumab
Experimental
Intensified- Methotrexate Vinblastin Doxorubicin Cisplatin +/- panitumumab
干预措施: Panitumumab (Drug)
结局指标
主要结局
Time to progression
时间窗: 9 months
Progression-Free Survival at 9 months post-treatment
次要结局
- Evaluation of time to progression(24 months)
- Toxicities assessment(24 months)
- Evaluation of response(24 months)
- Evaluation of overall survival(24 months)
研究者
研究点 (17)
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