EUCTR2012-002552-16-GB进行中（未招募）1 期
Cabazitaxel in platinum pre-treated patients with locally advanced or metastatic transitional cell carcinoma who developed disease progression within 12 months of platinum based chemotherapy. - Cab B1
niversity Hospitals Birmingham NHS Foundation Trust0 个研究点目标入组 20 人开始时间: 2012年10月15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
- 20
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. Written informed consent
- •2. Age = 18
- •3. Life expectancy = 12 weeks
- •4. Patients with histology/cytology confirmed Transitional Cell Carcinoma (TCC) including mixed pathology with predominantly TCC, with Locally advanced (T4b) or metastatic (lymph node or visceral) TCC arising from bladder or upper urinary tracts
- •5. Treated patients with incidental prostate cancer (pT2, Gleason = 6) and PSA (Prostate Specific Antigen) = 0.5 ng/mL are eligible
- •6. Measurable disease as per RECIST Criteria 1.1
- •7. ECOG Performance Status 0-1
- •8. Previously received first line platinum based treatment
- •9. Recurrence within 12 months (by RECIST criteria version 1.1) from last cycle of chemotherapy
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 26
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 70
排除标准
- •1. Previous therapy with a taxane
- •2. Pure non TCC histologies
- •3. Grade II or more peripheral neuropathy
- •4. Prior surgery, radiation, chemotherapy, or other anti-cancer therapy within 4 weeks prior to enrolment in the study
- •5. Uncontrolled severe illness or medical condition (including uncontrolled diabetes mellitus)
- •6. Inadequate organ and bone marrow function as evidenced by:
- •Hemoglobin <9.0 g/dL
- •Absolute neutrophil count <1.5 x 109/L,
- •Platelet count <100 x 109/L,
- •AST/SGOT and/or ALT/SGPT >2.5 x ULN;
- •Total bilirubin >1.0 x ULN,
- •Serum creatinine >1.5 x ULN. If creatinine 1.0 - 1.5 x ULN, creatinine clearance will be calculated according to CKD-EPI formula and patients with creatinine clearance = 30 mL/min should be excluded (see Appendix 6 for formula)
- •7. Symptomatic brain metastases or leptomeningeal disease (CT or MRI scan of the brain required only in case of clinical suspicion of central nervous system involvement)
- •8. History of another neoplasm except non-metastatic melanoma skin cancers, carcinoma in situ of the cervix, or cancer cured by surgery, small field radiation or chemotherapy < 5 years prior to randomization
- •9. History of inflammatory bowel disease, significant bowel obstruction
- •10. History of hypersensitivity to platinum, gemcitabine, taxanes, Polysorbate-80, or to compounds with similar chemical structures
- •11. Any of the following events within 6 months prior to randomization: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft surgery, clinically symptomatic and uncontrolled cardiovascular disease, or clinically significant arrhythmias (grade 3-4)
- •12. Concurrent treatment with strong inhibitors of cytochrome P450 3A4 or patients planning to receive these treatments (patients who were receiving treatment with such agents, a one-week washout period is required prior to randomization)
- •13. Women who are breastfeeding and women of child bearing potential (not postmenopausal (12 months of amenorrhea) or surgically sterile (absence of ovaries and/or uterus)) unless in agreement to use an adequate method of contraception during the treatment period and for 6 months after the last dose of the study drug. Men unless in agreement that they will use effective contraception (and condom to protect against exposure to seminal liquid) whilst participating in the trial and for 6 months after the last dose of study medication.
研究者
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