EUCTR2009-011882-10-FR进行中（未招募）不适用
Intensified methotrexate, vinblastine, doxorubicin and cisplatin (I-MVAC) with or without panitumumab as first-line treatment of advanced urothelial carcinoma in patients without H-Ras nor K-Ras mutations. Randomised phase II study.
FNCLCC (Fédération Nationale des Centres de Lutte Contre le Cancer)0 个研究点开始时间: 2010年1月4日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •1. Primary tumour of the bladder or upper urinary tract
- •2. Histologically confirmed infiltrating urothelial carcinoma (epidermoid and/or glandular forms are accepted)
- •3. Patients without H-Ras nor K-Ras mutations
- •4. Advanced disease defined by a locally advanced stage (T4 and/or N+) ineligible for surgical
- •resection, or a metastatic stage (M1)
- •5. Patients with at least 1 evaluable lesion as per RECIST criteria (version 1.1)
- •6. 18 = age = 75 years
- •7. General condition 0 or 1 as per the WHO scale
- •8. 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)
- •9. Haematological function: Haemoglobin > 11 g/dl, neutrophils = 1500/mm3, platelets =
- •100,000/mm3
- •10. Liver function: Grade* 0 ASAT and ALAT (< grade* 3 for liver metastases), grade* 0 alkaline
- •phosphatases, normal bilirubin
- •11. Renal function: calculated (or measured) creatinine clearance > 60 ml/min
- •12. Patients covered by a social security scheme
- •13. Patient having read the information sheet and signed the informed consent form.
- •* CTC AE v4.0
- •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
- •1. Pure adenocarcinoma or pure epidermoid carcinoma or mixed or pure small-cell neuroendocrine carcinoma
- •2. Previous treatment with one of the following molecules: methotrexate, vinblastine, doxorubicin or EGF-R inhibitor
- •3. History of interstitial pneumonitis or pulmonary fibrosis
- •4. 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)
- •5. Ventricular ejection fraction < 50%
- •6. Blood calcium and/or magnesium = grade* 1
- •7. 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,
- •8. Treatment with radiotherapy for analgesic purposes (unless treatment was discontinued at least 15 days prior to inclusion in the trial)
- •9. Potential allergy to panitumumab
- •10. 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
- •11. Pregnant women, or female subjects liable to become pregnant or currently breast-feeding,
- •12. Patient already included in another therapeutic trial on an investigational medicinal product,
- •13. Persons deprived of their freedom or under judicial protection (including guardianship),
- •14. Unable to receive medical follow-up during the trial owing to geographical, social or psychological reasons.
- •* CTC AE v4.0
研究者
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