EUCTR2013-002417-35-FI进行中（未招募）1 期
A multicenter, randomized phase II trial of vinflunine/gemcitabine versus carboplatin /gemcitabine as first line treatment in patients with metastatic urothelial carcinoma unfit for cisplatin based chemotherapy due to impaired renal function. - NUCOG I-VINGEM
Department of Oncology, Karolinska University Hospital0 个研究点目标入组 62 人开始时间: 2015年12月4日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 62
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
- •Signed informed consent.
- •Histological or cytological confirmed transitional cell carcinoma of the urothelial tract (mixed histology including transitional cell carcinoma are allowed).
- •Unresectable (T4b), locally advanced (lymph node positive (N+)) or metastatic (M1) urothelial carcinoma (including renal pelvic tumours, urethral tumours, urinary bladder tumours and urethral primary tumours).
- •No prior chemotherapy or other anti-cancer drugs. Patients who have received neoadjuvant or adjuvant platinum containing chemotherapy and who are diagnosed with loco regional recurrent or metastatic disease after 6 months are eligible.
- •Impaired renal function, creatinine clearance 30 – 60 ml/min (measured by Iohexol or Cr-EDTA technique)
- •ECOG/WHO Performance Status (PS) 0-1.
- •= 4 weeks since prior surgery, = 2 weeks since prior radiation therapy.
- •Measurable and/or non-measurable disease using the RECIST criteria defined as:
- •-Measurable disease: lesions that can be measured in at least one dimension and which have not been previously irradiated. Longest diameter = 20 mm with conventional techniques or = 10 mm with spiral CT scan or MRI.
- •-Non-measurable disease: lesions which have not been previously irradiated, longest diameter < 20 mm with conventional techniques or < 10 mm with spiral CT scan or MRI, or truly non measurable lesions including bone lesions, ascites, pleural/pericardial effusion, and lymphangitis cutis/pulmonitis.
- •CNS metastases and/or leptomeningeal metastases are allowed provided these have been adequately treated with radiotherapy, are stable and not generation any symptoms.
- •Spinal cord compression due to metastatic lesions is allowed provided adequate surgery and/or radiotherapy has been delivered, the metastases are stable and not generating any symptoms.
- •No known or suspected allergy to the investigational agents or any agents given in association with this trial.
- •18 years of age or older.
- •Fertile men and women of childbearing potential must use secure contraception from before entering the study until 6 months after end of 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 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •Not fulfilling inclusion criteria as described above
- •Pure non-transitional cell carcinoma of the urothelial.
- •Impaired bone marrow function defined as WBC < 3.0 x 109/L, neutrophils < 1.5 x 109/L, platelets < 125 x 109/L, haemoglobin < 100 g/L.
- •Impaired liver function defined as serum bilirubin > 1.5 x upper limit of normal (ULN) and/or ASAT/ALAT > 2.5 x ULN (> 5 x ULN if known liver metastasis).
- •Electrocardiogram (ECG) with significant modifications suggesting a high risk of occurrence of angina pectoris or high risk arrhythmia.
- •Other malignancies, except adequately treated basal carcinoma or squamos cell carcinoma of the skin or in-situ cervix carcinoma or incidental prostate cancer (T1a, Gleason score = 6, PSA < 0.5 ng/ml), or any other tumour with a disease free survival of = 5 years.
- •History of serious or concurrent illness or uncontrolled medical disorder; any medical condition that might be aggravated by chemotherapy treatment or which could not be controlled; including, but not restricted to:
- •-Active infection requiring antibiotics within 2 weeks before the study inclusion,
- •-Unstable diabetes mellitus,
- •-Hypercalcaemia >2.9 mmol/L or grade ? 2 according to CTCAE v 4.0,
- •-Concurrent congestive heart failure NYHA (class III-IV),
- •-Unstable angina pectoris, or myocardial infarction within 6 months and/or poorly controlled hypertension,
- •-Inflammatory bowel disease,
- •-Peripheral neuropathy grade = 2 according to CTCAE v 4.0,
- •Patients who require treatment with ketoconazole, itraconazole, ritonavir, amprenavir, indinavir, rifampicine (any potent CYP3A4 inhibitor or inducer) or phenytoine.
- •Pregnant or lactating women.
- •Any psychological, familial, sociological, or geographical condition which does not permit protocol compliance and medical follow-up.
研究者
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