EUCTR2011-003498-27-ES进行中（未招募）不适用
A phase II open label study of cabazitaxel in patients with advanced or metastatic transitional cell carcinoma of the urothelium who have progressed ?12 months after a previous platinum based chemotherapy.?Estudio fase II de cabazitaxel en pacientes con cáncer avanzado o metastásico de células transicionales de urotelio que han progresado en un intervalo inferior a 12 meses después de una quimioterapia basada en cisplatino.? - N/A
Grupo Español de Tratamiento de Tumores Genitourinarios (SOGUG)-Spanish Genitourinary Oncologic Group0 个研究点开始时间: 2011年10月28日最近更新:
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. Histologically confirmed transitional carcinoma of the urothelium (bladder, urethra, ureter,
- •or renal pelvis). Patients with mixed histology are eligible if transitional carcinoma is
- •predominant component (i.e. >50% of the pathologic specimen).
- •2. One previous cisplatin-based chemotherapy (with a minimum of 4 cycles).
- •a. Patients with unresectable locally advanced tumors or metastatic transitional cell
- •tumors of the urothelium who have progressed or relapsed after a maximum of 12
- •months since the last course of cisplatin-based chemotherapy.
- •b. Patients treated with adjuvant / neoadjuvant chemotherapy are eligible if their
- •relapse occurs ?12 months after the last cisplatin course; in this case, adjuvant or
- •neoadjuvant chemotherapy will be considered as the first line.
- •c. Patients with stable or responding disease at the end of first-line therapy should be
- •included only if they stabilization occurs after 6 cycles of chemotherapy.
- •3. Age ?18 years
- •4. Eastern Cooperative Oncology Group (ECOG) performance status of ?2.
- •5. Subjects must have signed an informed consent indicating that they understand the
- •purpose of and procedures required for the study and are willing to participate in the
- •6. At least one measurable lesion (RECIST criteria, Version 1.1).
- •7. At least 4 weeks and recovery from effects of the last chemotherapy course, prior surgery,
- •prior radiotherapy, or other therapy with an approved or investigational agent.
- •8. Adequate hematologic, hepatic, and renal function: Hemoglobin ?9.0 g/dL (transfusion
- •allowed), Platelet count ?100,000/?L, absolute neutrophil count > 1500/mm3, Serum
- •creatinine <1.5 x upper limit of normal (ULN) or a calculated creatinine clearance ? 50
- •ALT, AST and bilirrubin < 1.5 x ULN (<5xULN if liver metastasis are present). In
- •patients with previously documented Glibert?s disease, the upper limit of serum bilirubin
- •allowed is 3 mg/dL).
- •9. In female with childbearing potential, a pregnancy test have to be negative within 72 hours
- •priors to first dose of study drug. If fertile, patient have to agree to use an effective
- •method of contraception to avoid pregnancy for the duration of the study.
- •10. Estimated life expectancy of >12 weeks.
- •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 105
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 105
排除标准
- •Any patient who relapse after more than 12 months since the last chemotherapy course.
- •Patients who have received more than one prior chemotherapeutic regimen. Adjuvant or
- •neoadjuvant chemotherapy will be considered to have been first line (in this case, patients
- •will be eligible only if progression occurs within 12 months of the last course).
- •Tumors with neuroendocrine differentiation or small cell histology in any percentage of the
- •Non cisplatinum regimen as first chemotherapy.
- •Patients who received more than one cytotoxic chemotherapy regimen (either as adjuvant,
- •neoadjuvant or metastatic treatment).
- •Serious or uncontrolled coexistent nonmalignant disease, particularly active and
- •uncontrolled infection.
- •Neuropathy grade ? 2 (NCI CTC, Version 4.0), either post chemotherapy or secondary to a
- •different disease (diabetes, etc.).
- •Known metastasis or symptoms of metastasis to the central nervous system.
- •Clinically significant heart disease as evidenced by myocardial infarction, or arterial
- •thrombotic events in the past 6 months, severe or unstable angina, or New York Heart
- •Association (NYHA) Class III or IV heart disease or left ventricular ejection fraction (LVEF)
- •of <50% at baseline.
- •Subjects with childbearing potential who are not willing to use a method of birth control
- •with adequate barrier protection as determined to be acceptable by the principal
- •investigator and sponsor during the study and for 13 weeks after last study drug
- •administration.
- •Pregnancy or lactancy.
- •Condition or situation which, in the investigator?s opinion, may put the subjects at
- •significant risk, may confound the study results, or may interfere significantly with
- •subject?s participation in the study.
- •Prior treatment with a taxane or other tubulin-targeted agent including a vinca alkaloid.
- •Need to continue any regularly-taken medication that is a potent inhibitor or inducer of the
- •CYP3A pathway.
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