NL-OMON38902招募中不适用
A randomised Phase II/III study of cabazitaxel versus vinflunine in metastatic or locally advanced transitional cell carcinoma of the urothelium - Cabazitaxel vs. vinflunine in metastatic or locally advanced TCC
Associació Per a la Recerca Oncològica (APRO)0 个研究点目标入组 50 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1) The patient has given written informed consent stating that he or she understands the
- •purpose of the study and the procedures involved and agrees to participate in the study.
- •2) The patient has histologically confirmed TCCU (urinary bladder, urethra, ureter or renal
- •pelvis). Patients with mixed histology may be enrolled if transitional cell carcinoma is the
- •predominant component (i.e., > 50% of the histopathology sample), with the exception of
- •neuroendocrine or small cell carcinoma.
- •3) The patient has advanced disease defined as a locally advanced tumour considered to
- •be unresectable (T4b), node involvement in the inguinal area or above the aortic
- •bifurcation (that are considered to be distant nodes and so metastasis) or metastasis in
- •distant organs.
- •4) The patient should have received one prior platinum-based chemotherapy treatment for
- •locally advanced or stage IV TCCU. Prior platinum-based adjuvant or neoadjuvant
- •therapy is allowed if more than 6 months have elapsed since the end of adjuvant or
- •neoadjuvant therapy till tumour relapse.
- •5) The patient has at least one measurable tumour lesion (measurable disease, as defined
- •by the RECIST criteria v1.1), for the phase II part of the study. If all sites of measurable
- •disease have been irradiated, one site must have demonstrated growth after irradiation.
- •For phase III part, patients with only non measurable disease are allowed for enrolment.
- •6) Age >=18 years.
- •7) ECOG PS 0 or 1.
- •8) The patient may have no more than ONE of the following unfavourable risk factors:
- •a) haemoglobin <10 g/dL
- •b) presence of liver metastasis
- •c) ECOG PS 1
- •9) Life expectancy of at least 12 weeks.
- •10) Adequate hematologic, hepatic, and renal function, defined by:
- •a) Platelet count >=100 x109/L
- •b) Absolute neutrophil count (ANC) >1.5x109/L
- •c) Serum creatinine <=1.5 times the upper limit of normality (ULN). If creatinine
- •1.0-1.5 xULN, creatinine clearance will be calculated according to Chronic Kidney
- •Disease Epidemiology group (CKD-EPI) formula and patients with creatinine
- •clearance <60 mL/min should be excluded
- •d) Alanine aminotransferase (ALT/SGPT), aspartate aminotransferase (AST/SGOT) and
- •alkaline phosphatase (AP) <=2.5 ×ULN (<5 ×ULN in the presence of liver metastasis),
- •and serum total bilirubin <=1.0 ×ULN.
- •11) Females of childbearing potential must have a negative serum pregnancy test within 7
- •days of study entry. Patients of childbearing potential who participate in this study must
- •use effective contraceptive methods (e.g., abstinence, intrauterine device, oral or
- •injectable contraceptives, a double barrier method or surgical sterility) to prevent
- •pregnancy starting as soon as the informed consent form is signed and continuing for at
- •least 13 weeks after the last dose of the study medication is administered
排除标准
- •1) Patients that have 2 or more of the following unfavourable risk factors:
- •a) Haemoglobin <10 g/L
- •b) Liver metastasis
- •c) ECOG PS 1
- •2) Women who are currently pregnant or breast-feeding.
- •3) Any unresolved non-hematologic AE grade >1 (NCI-CTCAE, Version 4.0) from previous
- •anti-cancer therapy (other than alopecia).
- •4) Patients who had undergone major surgery, radiation therapy or treatment with
- •chemotherapy or any investigational agent within 28 days prior to Study day 1.
- •5) Evidence of severe or uncontrolled systemic disease or any concurrent condition
- •(including uncontrolled diabetes mellitus) which in the Investigator*s opinion makes it
- •undesirable for the subject to participate in the study or which would jeopardize
- •compliance with the protocol.
- •6) History of another neoplasm. Patients with prior history of either non-metastatic
- •non-melanoma skin cancers; carcinoma in situ of the cervix; or cancer cured by surgery,
- •small field radiation or chemotherapy >=3 years prior to randomisation; or treated patients
- •with early stage and low risk prostate cancer (<=pT2 N0 M0, Gleason <=6 and PSA <=0.5
- •ng/mL) at study entry will be eligible.
- •7) History of hypersensitivity reactions to taxanes (docetaxel) (cabazitaxel specific criteria),
- •vinca alkaloids (vinflunine specific criteria) or to any of the formulation excipients,
- •including polysorbate 80 (cabazitaxel specific criteria).
- •8) Patients with clear evidence or symptoms of central nervous system metastasis
- •(cabazitaxel specific criteria).
- •9) Clinically significant cardiac condition demonstrated by myocardial infarction or
- •thromboembolic events in the 6 months prior to the study treatment initiation, serious or
- •unstable angina pectoris, New York Heart Association (NYHA) class III or IV congestive
- •heart failure, or left ventricular ejection fraction (LVEF) < 50% at baseline (see Appendix
- •VI) (vinflunine specific criteria).
- •10) Concurrent or planned treatment with strong inhibitors or strong inducers of cytochrome
- •P450 3A4/5 (a one week wash-out period is necessary for patients who are already on
- •these treatments) (see Appendix XII).
研究者
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